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Past Calendar of Events

The SOT Calendar of Events is a comprehensive listing of all the scientific meetings that are happening over the next several months domestically and abroad.

We invite you to contribute an event listing to the SOT Web site. Only postings related to the field of toxicology or pertinent to science are permissible. All submission are reviewed and approved before they display in the Calendar of Events.

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Event Type: Other Scientific Events
Organization: ExL Pharma
Event Title: 5th CMO Quality Oversight and Risk Management
Event Date or Start Date: 4/23/2015
End Date: 4/24/2015
Country: UNITED STATES
State or Region: MA
Meeting Web Site: atnd.it/19481-0
Additional Meeting Information: Strategic Insights on Drug Development Outsourcing to a Contract Manufacturing Organization in an Evolving Regulatory Landscape.

The 5th CMO Quality Oversight and Risk Management Summit will bring together industry innovators to connect and discuss the latest outsourcing trends and hot button issues in pharmaceutical, biotechnology and medical device contract manufacturing.

Designed to optimize partnerships between pharma companies and CMO, the Summit serves as a networking platform while offering professionals vital information on how to strategically navigate the outsourcing space. Participants will learn best practices to effectively oversee and manage external manufacturers, tips on utilizing Big Data analytics to improve CMO results, the newest FDA policies and their impact on CMO partnerships, effective risk management strategies to help pharma companies get the best bang for their buck, the latest outsourcing trends, and additional regulatory challenges.

Time: 9:00 am to 5:00 pm

Venue details
Wyndham Boston Beacon Hill
5 Blossom Street, Boston 02114, United States


Event Type: Other Scientific Events
Organization: UBM EMEA
Event Title: CPhI Japan 2015
Event Date or Start Date: 4/22/2015
End Date: 4/24/2015
Country: JAPAN
State or Region:
Meeting Web Site: atnd.it/19655-0
Additional Meeting Information: CPhI Japan and co-located events ICSE, P-MEC | LABWorld, BioPh, and InnoPack are the ultimate one-stop-shop for all pharma relevant activity concerning Japan.

Event Type: Webinars
Organization: Society of Toxicology
Event Title: CCT Webinar: Science-Based Decision-Making to Enhance Regulatory Success
Event Date or Start Date: 4/16/2015
End Date: 4/16/2015
Country:
State or Region:
Meeting Web Site: www.toxicology.org/ms/cctWebinars.asp#risk_assessment
Additional Meeting Information: Diversity is increasing in the biological targets, pharmacological strategies, and types of chemistry being investigated in first time in human (FTIH) studies; similarly, there is growing information, guidance, and experience to protect volunteer/patient safety. In response, regulatory toxicology strategies have diversified and evolved from those practiced only a decade ago reflecting advances in science and technology and the experiences of individuals and organizations. These webinars will address how we understand and work with this diversity both now and in the future to bring important new (and safer) medicines to patients.

These webinars will focus on four key areas: small molecules, traditional biologics, innovative biologics, and nucleotide constructs. For each of these we will address the relevant aspects of science and technology, strategic and tactical issues (study design, species selection, target organ toxicity profiles), and regulatory guidance relevant to safety assessment, including approaches in rare diseases. There will also be a future focus as we consider new directions in the field, including reducing or moving away from animal testing. These webinars will be of broad interest to academic, industry, regulatory, and consultant toxicologists who wish to be updated in this critical and evolving area.

Event Type: Other Scientific Events
Organization: CARTaGENE
Event Title: Symposium: Cohort, BIG Data and Personalized Medicine—Challenges and Solutions
Event Date or Start Date: 4/16/2015
End Date: 4/17/2015
Country: CANADA
State or Region:
Meeting Web Site: symposium.cartagene.qc.ca/
Additional Meeting Information: The first Canadian Symposium bringing together regional, national and international population cohorts under one roof.

The primary objective of the Symposium is to highlight current resources and utilization of population cohort data in an interactive format. The key challenges associated with managing, analyzing and capturing novel findings from complex heterogeneous sources will be raised and the conclusions written as a white paper, which will inform decision makers on the importance of the immediate need for new analytical solutions and resources.

Event Type: SOT Sponsored Non-SOT Meeting
Organization: Society of Toxicology in conjunction with US FDA Center for Food Safety and Applied Nutrition
Event Title: SOT FDA Colloquia: Immunotoxicology in Food and Ingredient Safety Assessment: Approaches and Case Studies
Event Date or Start Date: 4/14/2015
End Date: 4/14/2015
Country: UNITED STATES
State or Region: MD
Meeting Web Site: www.toxicology.org/ai/meet/fda/fdacolloquia041415.asp
Additional Meeting Information: The focus of this colloquium is on the methods used in safety assessment of substances present in foods that may target the immune system. The immune system is a complex set of cellular, chemical, and soluble mediators that protects the body against foreign substances. Immunotoxicology is the subdiscipline of toxicology that focuses on unintended modulation of the immune system following exposure to environmental chemicals or therapeutics. Adverse effects may include immunosuppression, immunostimulation, allergic hypersensitivity, or autoimmunity, and may result in outcomes such as increased incidences of infectious diseases or neoplastic diseases, allergy/asthma, or autoimmune diseases, respectively. The majority of immunotoxicity testing efforts to date have focused on the potential for xenobiotics to suppress immune function or induce dermal sensitization. With the increased use and development of immune-based or immune-targeted therapeutic proteins, unintended stimulation of the immune system has also become an area of concern. The colloquium will begin with a brief overview of the cells and soluble mediators critical to immune function and the tiered testing strategies used to identify substances that may target immune effectors. Following this introduction, experts will provide a state of the art review of methodological approaches using case studies to elucidate how immunotoxicology data can be used in assessing the safety of ingested materials.

Event Type: Other Scientific Events
Organization: IQPC Worldwide Pte Ltd
Event Title: 6th annual Bio/Pharmaceutical Cold Chain China 2015
Event Date or Start Date: 4/14/2015
End Date: 4/15/2015
Country: CHINA
State or Region: Shanghai
Meeting Web Site: atnd.it/20594-0
Additional Meeting Information: From July 1, 2013, newly established pharmaceutical trading enterprises and those applying for the reconstruction or expansion of their business premises and warehouses shall comply with the new requirements outlined in the Revised GSP Standards. Such enterprises will be issued the new Pharmaceutical Trading License and Pharmaceutical GSP Certificate if they are qualified.

By December 31, 2014, wholesale enterprises entrusted with drug storage and distribution and enterprises engaged in the wholesale of the following pharmaceutical products shall comply with the requirements prescribed by the Revised GSP Standards—Vaccines; Narcotic drugs; Psychotropic substances; Anabolic agents; and Peptide hormones.

Qualified enterprises will be issued the new Pharmaceutical Trading License and Pharmaceutical GSP Certificate, while for those failing to comply with the new standards, their corresponding business scope will be narrowed and relevant qualifications will be cancelled.

By December 31, 2015, all pharmaceutical trading enterprises must satisfy the new requirements regardless of the validity status of their Pharmaceutical Trading License and Pharmaceutical GSP Certificate.

From January 1, 2016, pharmaceutical trading enterprises that fail to meet the requirements prescribed by the Revised GSP Standards are not allowed to continue drug operation activities in the country.

To ensure that your pharmaceutical cold chain is in compliant with the new regulation, 6th Annual Bio/Pharmaceutical Cold Chain is going to gather 120+ senior practitioners from pharmaceutical manufacturers, distributors, third party logistics providers and other solution providers to share the best practice improve the pharmaceutical cold chain quality in China.


Event Type: Other Scientific Events
Organization: DIA Europe
Event Title: 8th Annual Clinical Forum
Event Date or Start Date: 4/14/2015
End Date: 4/15/2015
Country: FRANCE
State or Region: Paris
Meeting Web Site: atnd.it/11031-0
Additional Meeting Information: The DIA Clinical Forum is widely recognized as the only European conference that brings together industry thought leaders across the key disciplines of data management, clinical operations, drug safety, and medical writing.

The conference shares experience, case studies, lessons learned and best practices with professional colleagues from all disciplines. The increasing success of the cross-functional sessions has secured their place in the program.


Event Type: Other Scientific Events
Organization: DIA Europe
Event Title: 27th DIA Annual EuroMeeting
Event Date or Start Date: 4/13/2015
End Date: 4/15/2015
Country: FRANCE
State or Region: Paris
Meeting Web Site: atnd.it/11043-0
Additional Meeting Information: The DIA’s Annual EuroMeeting is global in scope and attracts well over 3,000 professionals from more than 50 countries.

It brings together professionals from the biopharmaceutical industry, contract research and service organizations, academic research centers, regulatory agencies and health ministries as well as delegates from patient organizations.

This convergence affords participants the opportunity to network with professional colleagues from around the world.


Event Type: Webinars
Organization: Massachusetts Society for Medical Research (MSMR)
Event Title: Introduction to IACUCs, Revised, and Updated
Event Date or Start Date: 4/10/2015
End Date: 4/10/2015
Country:
State or Region:
Meeting Web Site: www.msmrcourses.org/courses/introduction-to-animal-care-and-use-committees/
Additional Meeting Information: This 6-week course covers all the basics for a new community member. It is also good adjunct training for new IACUC adminstrators or members who have not yet had the chance to take IACUC 101 or a similar course.

Event Type: Other Scientific Events
Organization: Massachusetts Society for Medical Research (MSMR)
Event Title: Laboratory Animal Enrichment Symposium
Event Date or Start Date: 4/9/2015
End Date: 4/9/2015
Country: UNITED STATES
State or Region: MA
Meeting Web Site: events.r20.constantcontact.com/register/eventReg?llr=iewyzvcab&oeidk=a07eaia4vscd04b020f&oseq
Additional Meeting Information: Free to MSMR members. Our 7th Enrichment Symposium. These are always sellouts.

Event Type: Other Scientific Events
Organization: UBM EMEA
Event Title: CPhI South East Asia, P-MEC, InnoPack
Event Date or Start Date: 4/8/2015
End Date: 4/10/2015
Country: INDONESIA
State or Region:
Meeting Web Site: atnd.it/20672-0
Additional Meeting Information: Join the 3 Pharma Events under one roof Meet the movers and shakers in Indonesia’s within the three most important sectors of pharma manufacturing: ingredients, machinery and equipment and packaging for competitive advantage that will help grow your business. Expand your professional network in the ASEAN pharma market at CPhI South East Asia, where you will meet key decision makers and business partners who can help you capitalize on opportunities presented in this dynamic, growing market.

Event Type: Webinars
Organization: MentorHealth
Event Title: Issues with Risk Assessments for Cross Contamination of OSD Facilities
Event Date or Start Date: 4/8/2015
End Date: 4/8/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: bit.ly/1DTiNzL
Additional Meeting Information: The webinar will explore the typical processes used in Oral Solid Dosage. Equipment issues will be explored and critical issues outlined We will look at facility, HVAC and equipment issues.

Event Type: Webinars
Organization: MentorHealth
Event Title: Modern Science & Ancient Wisdom Combine to Accelerating Personal Wellbeing & Transformation through Neuroscience - Webinar by Mentorhealth
Event Date or Start Date: 4/7/2015
End Date: 4/7/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: cellgenetherapy.conferenceseries.com/
Additional Meeting Information: This webinar will address these and more. Significant breakthroughs in neuroscience, an interdisciplinary brain-based science, have led to new advancements in emotional healing, personal transformation and healthy lifestyle.

Higher Brain Living® uses knowledge of the body''s energy systems with a physiological gentle-touch and self-directed personal change process.

The Higher Brain is awakened and energized over a 22-session process. This results in a shift in brain dominance to the Higher Brain.

Event Type: Webinars
Organization: MentorHealth
Event Title: Physician Hospital Integration
Event Date or Start Date: 4/7/2015
End Date: 4/7/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: bit.ly/1aIrS5j
Additional Meeting Information: This presentation and discussion will deal with the history of integration towards large healthcare systems and that pace is rapidly increasing. It is important that leaders and managers should understand the pros and cons and the good and the bad and the ugly of integration.

Event Type: Other Scientific Events
Organization: GCPseminars
Event Title: GCPseminars Workshop on Applied Statistics for QA, QC, Manufacturing, and Design Control
Event Date or Start Date: 3/26/2015
End Date: 3/27/2015
Country: UNITED STATES
State or Region: MA
Meeting Web Site: www.gcpseminars.com
Additional Meeting Information: The 2-day seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics. Basic vocabulary and concepts are then reviewed and discussed.

Event Type: Specialty Section
Organization: Clinical and Translational Toxicology Specialty Section
Event Title: Clinical and Translational Toxicology Specialty Section Meeting/Reception
Event Date or Start Date: 3/25/2015
End Date: 3/25/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/isot/ss/CTTSS/index.asp
Additional Meeting Information: San Diego Convention Center 6:00 PM– 7:30 PM

Event Type: Specialty Section
Organization: Dermal Toxicology Specialty Section
Event Title: Dermal Toxicology Specialty Section Meeting/Reception
Event Date or Start Date: 3/25/2015
End Date: 3/25/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/dtss/index.html
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Specialty Section
Organization: Ethical, Legal, and Social Issues Specialty Section
Event Title: Ethical, Legal, and Social Issues Specialty Section Luncheon/Reception
Event Date or Start Date: 3/25/2015
End Date: 3/25/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/ELSI/index.asp
Additional Meeting Information: San Diego Convention Center 12:00 Noon–1:30 PM

Event Type: Specialty Section
Organization: Biological Modeling Specialty Section
Event Title: Biological Modeling Specialty Section Meeting/Reception
Event Date or Start Date: 3/25/2015
End Date: 3/25/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/BMSS/
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Specialty Section
Organization: Biotechnology Specialty Section
Event Title: Biotechnology Specialty Section Meeting/Reception
Event Date or Start Date: 3/25/2015
End Date: 3/25/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/isot/ss/btss/index.asp
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Specialty Section
Organization: In Vitro and Alternative Methods Specialty Section
Event Title: In Vitro and Alternative Methods Specialty Section Luncheon/Meeting
Event Date or Start Date: 3/25/2015
End Date: 3/25/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/ivss/index.htm
Additional Meeting Information: San Diego Convention Center 12:00 Noon–1:30 PM

Event Type: Specialty Section
Organization: Mechanisms Specialty Section Meeting
Event Title: Mechanisms Specialty Section Meeting/Reception
Event Date or Start Date: 3/25/2015
End Date: 3/25/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/mechanisms/Index.html
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Specialty Section
Organization: Reproductive and Developmental Toxicology Specialty Section
Event Title: Reproductive and Developmental Toxicology Specialty Section Meeting/Reception
Event Date or Start Date: 3/25/2015
End Date: 3/25/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/repdevtox/
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Specialty Section
Organization: Stem Cells Specialty Section
Event Title: Stem Cells Specialty Section Meeting/Reception
Event Date or Start Date: 3/25/2015
End Date: 3/25/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/isot/ss/scss/index.asp
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Specialty Section
Organization: Drug Discovery Toxicology Specialty Section
Event Title: Drug Discovery Toxicology Specialty Section Meeting/Reception
Event Date or Start Date: 3/24/2015
End Date: 3/24/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/isot/ss/DDTSS/index.asp
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Specialty Section
Organization: Cardiovascular Toxicology Specialty Section
Event Title: Cardiovascular Toxicology Specialty Section Luncheon/Meeting
Event Date or Start Date: 3/24/2015
End Date: 3/24/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/CVTSS/index.asp
Additional Meeting Information: San Diego Convention Center 12:00 Noon–1:30 PM

Event Type: Specialty Section
Organization: Food Safety Specialty Section
Event Title: Food Safety Specialty Section Meeting/Reception
Event Date or Start Date: 3/24/2015
End Date: 3/24/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/foodsafe/index.asp
Additional Meeting Information: San Diego Convention Center 6:00 PM - 7:30 PM

Event Type: Specialty Section
Organization: Immunotoxicology Specialty Section
Event Title: Immunotoxicology Specialty Section Meeting/Reception
Event Date or Start Date: 3/24/2015
End Date: 3/24/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/imtox/Index.asp
Additional Meeting Information: San Diego Convention Center 6:00 PM– 7:30 PM

Event Type: Specialty Section
Organization: Medical Device and Combination Product Specialty Section
Event Title: Medical Device and Combination Product Specialty Section Meeting/Reception
Event Date or Start Date: 3/24/2015
End Date: 3/24/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/mdcpss/Index.asp
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Specialty Section
Organization: Metals Specialty Section
Event Title: Metals Specialty Section Meeting/Reception
Event Date or Start Date: 3/24/2015
End Date: 3/24/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/Metals/Index.asp
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Specialty Section
Organization: Nanotoxicology Specialty Section
Event Title: Nanotoxicology Specialty Section Meeting/Reception
Event Date or Start Date: 3/24/2015
End Date: 3/24/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/isot/ss/nano/index.asp
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Specialty Section
Organization: Neurotoxicology Specialty Section
Event Title: Neurotoxicology Specialty Section Meeting/Reception
Event Date or Start Date: 3/24/2015
End Date: 3/24/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/isot/ss/NTSS/index.asp
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Specialty Section
Organization: Occupational and Public Health Specialty Section
Event Title: Occupational and Public Health Specialty Section Luncheon/Meeting
Event Date or Start Date: 3/24/2015
End Date: 3/24/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/ophss/index.asp
Additional Meeting Information: San Diego Convention Center 12:00 Noon–1:30 PM

Event Type: Specialty Section
Organization: Ocular Toxicology Specialty Section
Event Title: Ocular Toxicology Specialty Section Meeting/Reception
Event Date or Start Date: 3/24/2015
End Date: 3/24/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/isot/ss/otss/index.asp
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Specialty Section
Organization: Risk Assessment Specialty Section
Event Title: Risk Assessment Specialty Section Meeting/Reception
Event Date or Start Date: 3/24/2015
End Date: 3/24/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/RiskAssess/index.asp
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Other Scientific Events
Organization: IQPC Germany
Event Title: 6th International Conference Clinically Relevant Drug Transporters
Event Date or Start Date: 3/24/2015
End Date: 3/26/2015
Country: GERMANY
State or Region: Berlin
Meeting Web Site: atnd.it/21106-0
Additional Meeting Information:

Successfully implementing regulatory guidelines and enhancing innovative assessment strategies by applying optimized modelling tools

Venue details: Maritim proArte Hotel Berlin, Friedrichstraße 151, Berlin 10117, Germany


Event Type: Other Scientific Events
Organization: Pharma IQ
Event Title: PAT and Quality by Design
Event Date or Start Date: 3/23/2015
End Date: 3/25/2015
Country: UNITED KINGDOM
State or Region: London
Meeting Web Site: atnd.it/21114-1
Additional Meeting Information: Maximize Production Efficiency, Reduce Production Cycle Time, Reduce Cost, and Increase Product Quality with PAT and Quality by Design

The annual PAT and QbD Conference is heading into its 12th year with an outstanding line up of speakers and content. Bringing you exclusive regulatory insight, brand new case studies of PAT and QbD implementation, strategies to achieve process control and movement towards continuous manufacturing.

This event is focused on interaction, with a goal to facilitate discussion and problem solving through a variety of panel discussions and round table sessions!

Event Type: Specialty Section
Organization: Mixtures Specialty Section
Event Title: Mixtures Specialty Section Meeting/Reception
Event Date or Start Date: 3/23/2015
End Date: 3/23/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/isot/ss/Mix/index.asp
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Specialty Section
Organization: Molecular and Systems Biology Specialty Section
Event Title: Molecular and Systems Biology Specialty Section Meeting/Reception
Event Date or Start Date: 3/23/2015
End Date: 3/23/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/molecular/index.asp
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Specialty Section
Organization: Regulatory and Safety Evaluation Specialty Section
Event Title: Regulatory and Safety Evaluation Specialty Section Meeting/Reception
Event Date or Start Date: 3/23/2015
End Date: 3/23/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/RSESS/index.asp
Additional Meeting Information: San Diego Convention Center 6:00 PM–7:30 PM

Event Type: Specialty Section
Organization: Toxicologic and Exploratory Pathology Specialty Section
Event Title: Toxicologic and Exploratory Pathology Specialty Section Luncheon/Meeting
Event Date or Start Date: 3/23/2015
End Date: 3/23/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/ISOT/SS/TEP/index.html
Additional Meeting Information: San Diego Convention Center 12:00 Noon–1:30 PM

Event Type: Webinars
Organization: Partnerships for Environmental Public Health
Event Title: Risk Communication: Addressing the Needs of Your Community
Event Date or Start Date: 3/20/2015
End Date: 3/20/2015
Country:
State or Region:
Meeting Web Site: webmeeting.nih.gov/peph
Additional Meeting Information: Communicating risk to the public is important for mitigating existing exposures or preventing future exposures that may adversely affect health. However, communicating effectively requires using appropriate methods and techniques. Scientists and communication specialists have been examining the impact that different types of risk communication have played in real and perceived public health risks in order to guide translational efforts. Such research has identified optimal approaches for how messages can be communicated to achieve the desired results. This webinar features two investigators from the NIEHS-funded Deepwater Horizon Research Consortium who have developed communication approaches for at-risk populations in the context of disaster events. They will discuss approaches for building trust and respect with research partners, creating culturally sensitive communications, and delivering actionable risk messages to individuals and communities.

Event Type: Other Scientific Events
Organization: Stereology Resource Center
Event Title: 2015 Spring Stereology Workshop
Event Date or Start Date: 3/20/2015
End Date: 3/21/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.stereologyresourcecenter.com/services/workshops/
Additional Meeting Information: The 2015 Spring Stereology Workshop will be held prior to the 54th Annual Meeting of the Society for Toxicology in San Diego, California.

Workshop Goals:

  • Teach participants to recognize and avoid all known sources of stereology and non stereology bias.
  • Provide a sound background in the theoretical and practical foundations of stereology.
  • Offer participants one-on-one reviews of their projects with study design experts.
  • Review the histological requirements for reliable stereology studies.
  • Train participants in the overall configuration and operation of computerized stereology systems.
  • Instruct participants in the techniques available to optimize tissue sampling for maximal efficiency.

Event Type: Annual Meeting
Organization: GTCbio
Event Title: 7th Ocular Diseases Drug Discovery Conference
Event Date or Start Date: 3/19/2015
End Date: 3/20/2015
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.gtcbio.com/conferences/ocular-diseases-drug-discovery-overview
Additional Meeting Information: The conference continues to offer presentations on novel therapeutics in ocular drug development and discovery. This is a platform for excellent networking, exchanging ideas, and sharing challenges; all with a united goal of bringing innovative and progressive treatments to patients in the field of ophthalmology.

The conference promotes the discovery of drug development and therapeutics in ocular diseases by gathering leading scientists, researchers, and experts to discuss and collaborate on the latest R&D, safety assessment, regulatory issues, and drugs in development for combating and curing age-related macular degeneration (AMD), diabetic retinopathy, glaucoma, diabetic macular edema (DME), uveitis, and other ocular diseases.

Event Type: Other Scientific Events
Organization: GCPseminars
Event Title: GCPseminars Workshop on Using Statistical Methods for ICH Guidelines
Event Date or Start Date: 3/19/2015
End Date: 3/20/2015
Country: UNITED STATES
State or Region: DC
Meeting Web Site: www.gcpseminars.com
Additional Meeting Information: This hands-on course will provide attendees with an understanding of how to apply statistical methods to the ICH Q series guidelines. The course will deliver tools, templates and insight that will allow participants to immediately begin implementation within their organization/firm.

This two day hands-on workshop explores the unique challenges facing all facets of a pharmaceutical or biotechnology company. Practical implementation solutions as well as best practice descriptions that will allow management to effectively assess, manage, and mitigate risk of poorly designed studies.

Participants will learn the major aspects of the statistical methods and discover how organizations and external authorities expect organizations to meet these guidelines.

Areas Covered in the Session:

  • Introduction to ICH Q Series
  • Introduction/Fundamentals - Statistics
  • Integrating Statistics into protocols
  • Regression - Q1
  • Design of Experiments and ANOVA - Q8
  • Sample Size - Q6
  • Probability - Q9
  • Interactive Discussion/Questions
  • Developing a risk strategy

Who Will Benefit:

  • Quality Managers
  • Assay Development Scientists
  • Quality Analysts
  • Research Scientists
  • Risk Managers
  • Quality Managers

Agenda

Day One
Lecture 1: Introduction/Fundamentals - Statistics

  • Summary Statistics
  • Graphical Techniques
  • Hypothesis Testing
  • Confidence Intervals and Tolerance Intervals
  • Interactive Discussion/Questions

Event Type: Other Scientific Events
Organization: SMi Group Ltd
Event Title: Containment of Highly Potent APIs
Event Date or Start Date: 3/17/2015
End Date: 3/17/2015
Country: UNITED KINGDOM
State or Region: London
Meeting Web Site: atnd.it/20018-0
Additional Meeting Information:

SMi is delighted to announce that the Containment of Highly Potent API''s masterclass will take place on the 17th March 2015 in London, UK

SMi Group are proud to introduce its masterclass taking place on 17th March 2015 in Central London, Containment of Highly Potent APIs. A significant proportion of new drugs under development contain high-potency active pharmaceutical ingredients (HPAPIs), which is leading to explosive growth in demand for their production. The cytotoxicity of HPAPIs, however, presents handling challenges and requires heavy investment in specialized containment to ensure that employees and their environment are protected from exposure.

This workshop examines the planning, equipment, and facility design of chemical and biologic HPAPIs as well as biologic—HPAPI conjugate manufacture. It also outlines the efforts made by the pharmaceutical industry to develop voluntary standards for HPAPI production and handling and will assess how to improve understanding on containment and identifying how to minimize the risks of exposure.

Why you should attend:

Hazard Assessment of Potent Pharmaceutical Compounds —What to Trust

  • Choosing Control and Containment Strategies
  • Designing for Both Potent Compound Safety and Quality
  • Demonstrating Control to Employers, Customers and Others

Hosted by: Justin Mason-Home, Managing Director, SafeBridge Europe Limited and Scott Patterson, Vice President Commercial Sales, ILC Dover Inc

HOW TO REGISTER Book before 30 January & save £100 Register online at www.smi-online.co.uk/2015containment-api1.asp Contact Fateja Begum on +44 (0) 20 7827 6184 or email fbegum@smi-online.co.uk

URLs: Booking: http://atnd.it/20018-1

Price Masterclass: GBP 599.00

Speakers: Justin Mason-Home, Managing Director, SafeBridge Europe Limited and Scott Patterson, Vice President Commercial Sales, ILC Dover Inc

Time: 8:30 AM to 4:20 PM

Venue details Holiday Inn Bloomsbury Coram Street, London, WC1N 1HT, United Kingdom


Event Type: Other Scientific Events
Organization: SMi Group Ltd
Event Title: An Insight into Diabetes
Event Date or Start Date: 3/17/2015
End Date: 3/17/2015
Country: UNITED KINGDOM
State or Region: London
Meeting Web Site: atnd.it/20017-1
Additional Meeting Information:

SMi is delighted to announce that the An Insight into Diabetes masterclass will take place on the March 17, 2015 in London UK.

Time: 8:30 AM - 4:15 PM

Price: Masterclass: GBP 599

Speakers: Wim Wientjens, Ambassador, International Diabetes Federation


Event Type: Other Scientific Events
Organization: GCPseminars
Event Title: GCPseminars Workshop on Applied Statistics for Scientists and Engineers
Event Date or Start Date: 3/12/2015
End Date: 3/13/2015
Country: UNITED STATES
State or Region: PA
Meeting Web Site: https://www.gcpseminars.com
Additional Meeting Information: Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices.

Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Simple linear regression and analysis-of-covariance (ANCOVA) are used for setting expiries and conducting stability analysis studies. Two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used for analyzing designed experiment for process development and validation studies. Descriptive statistics (distribution, summary statistics), run charts, and probability (distributions) are used for developing process control charts and developing process capability indices.

This course provides instruction on how to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building. Once competence in each of these areas is established, industry-specific applications will be presented for the participants.


Event Type: Other Scientific Events
Organization: GCPseminars
Event Title: GCPseminars Workshop on The A to Z’s of Microbial Control, Monitoring and validation of Pharmaceutical Water Systems
Event Date or Start Date: 3/12/2015
End Date: 3/13/2015
Country: UNITED STATES
State or Region: PA
Meeting Web Site: www.gcpseminars.com
Additional Meeting Information: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not necessary. The instructor can provide the background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system design and control are merely managed by a set of rules that often don''t work and can cause very costly system downtime or even product recalls.

Why should you attend:

(Fear, uncertainty and doubt (FUD) liner for the marketing purpose)—Are you having persistent water system problems—nothing you do seems to help for very long if at all? Are your water systems excursion investigations always inconclusive because you can never confirm the original out-of-limit result and the bad results come and go? Are you concerned that FDA will not think your water system validation was not stringent enough because of your current microbial problems? Are you afraid that biofilm has taken over and you can''t get rid of it?

These are common concerns that primarily originate out of ignorance of appropriate design, maintenance, sanitization, sampling, and testing for your water system. Attending this two-day course will open your eyes to what is really going on in your water system.

Event Type: Other Scientific Events
Organization: GCPseminars
Event Title: GCPseminars Workshop on Regulatory Compliance for Dietary Supplements in the US, EU and Canada
Event Date or Start Date: 3/12/2015
End Date: 3/13/2015
Country: UNITED STATES
State or Region: PA
Meeting Web Site: www.gcpseminars.com
Additional Meeting Information: The course will cover basic regulatory requirements for marketing of dietary supplements in the U.S. and Canada including product safety, manufacturing, product claims, and labelling requirements. A general overview of EU regulations will also be given.

Why you should attend:

In order to successfully market dietary supplements in the U.S. and Canada, it''s essential to understand and implement regulatory requirements for these regions. This 2 day seminar will help you understand these basic requirements to assure regulatory compliance necessary for product marketing.

Who Will Benefit:

  • Executives of Dietary Supplement companies
  • Regulatory Compliance Professionals
  • Quality Assurance Professionals
  • Dietary Supplement Manufacturers
  • Dietary Supplement Distributors
  • Sales/Marketing Personnel

Agenda

For the U.S.: Key requirements for how dietary supplements are regulated including dietary supplement sale, marketing, manufacturing, labelling, claims, advertising and adverse event reporting.

For Canada: NHP licensing and submission requirements, manufacturing requirements, site license requirements, labelling and consumer advertising of NHP products. EU: EU Regulatory framework, the EU Food Supplements Directive and the role of the EFSA will be covered in general.

Day One

Lecture 1: US Dietary Supplement history & background:
  • In depth look at the Dietary Supplement Health & Education Act and how US FDA defines acceptable dietary supplements vs. those that aren’t in compliance.
Lecture 2: US FDA requirements for Dietary Supplement Labeling and Adverse Event reporting.
  • A thorough review of US Dietary Supplement labeling compliance requirements with emphasis on Supplement Facts label regulations.
  • Adverse Event reporting will also be covered.

Lecture 3: Dietary Supplement Claims & Advertising in the US Covers different types of allowable dietary supplement claims and how to make the best claims in labeling and advertising without violating US FDA regulations.
  • Structure/Function claims will be covered in depth.
  • FTC’s role in regulating dietary supplement advertising will also be covered.

Lecture 4: Dietary Supplement Manufacturing GMPs in the US
  • How GMPs establish standards for identity, purity, strength and composition of dietary supplements and their component dietary ingredients.
  • Specific GMP requirements for control, testing, and record keeping will be covered, as well as FDA facility registration requirements.

Day Two

Lecture 5: Canada’s Natural Health Product (NHP) regulations:
  • How they differ from US regulations.
  • Health Canada’s NHP requirements and submission process will be covered.
  • The role of Canada’s Natural Health Products Directorate will be reviewed.
Lecture 6: Canadian NHP product licensing & site licensing requirements.
  • What applicants need to obtain a Canadian license to market NHP products and the Health Canada approval process will be covered as will compliance with Canadian GMP regulations.
Lecture 7: Safety & Efficacy and labelling & advertising requirements for Canadian NHPs and how adverse events are handled.
  • Canadian evidence requirements for safety and efficacy and NHP labelling requirements will be covered as well as Canadian health claim requirements and adverse event reporting.
Lecture 8: EU Dietary Supplement regulation and framework and EU Food Supplement Directive—a general overview.
  • The EU Food Supplements Directive of 2002, which applies to vitamin & mineral supplements, will be covered.
  • A general review of the EU Commission’s harmonized rules for food supplements and the role of the EFSA will be given.

Speaker:

Norma Skolnik has over 30 years of US regulatory experience, starting in the drug industry. She was Associate Director of Regulatory Affairs at Lederle Laboratories and then became Associate Director of Regulatory Affairs at Lederle Consumer Health where she helped launch Centrum vitamins. When Lederle was acquired by Wyeth, she became Associate Director of Regulatory Affairs, there acquiring more experience in the Dietary Supplement and OTC drug fields.

Event Type: Other Scientific Events
Organization: SMi Group Ltd
Event Title: CNS Orphan Diseases - The Alternative Route in CNS
Event Date or Start Date: 3/10/2015
End Date: 3/10/2015
Country: UNITED KINGDOM
State or Region: London
Meeting Web Site: atnd.it/20076-1
Additional Meeting Information: This master class will look at the challenges and potential advantages of developing drugs in CNS Orphan diseases and much more.

Event Type: Annual Meeting
Organization: SMi Group Ltd
Event Title: Biosimilars: Designing and Building the Clinical Package
Event Date or Start Date: 3/10/2015
End Date: 3/10/2015
Country: UNITED KINGDOM
State or Region: London
Meeting Web Site: atnd.it/20080-1
Additional Meeting Information:

The patent expiry of a number of biologics that have revolutionized medical practice is imminent. Numerous programs have been initiated to develop corresponding follow-on products. Regulatory agencies have issued guidance on abbreviated clinical requirements for marketing authorizations tailored to such replicates.

This workshop will provide a detailed overview over the thinking behind the abbreviated clinical evidence base, and the purpose the different components serve. The Master-class will speak to aspects such as the“sensitivity” of the selected clinical model, the role of clinical evidence in the “totality of evidence,” as well as operational aspects of the clinical trials. As product safety plays a central role in stakeholder expectations particular attention will be given to means to address this important topic.

Why you should attend:

  • Biosimilars has become a very active and exciting arena. This master class will give you valuable insights into the principles that shape this space, including its challenges and opportunities.
  • Network with your peers and gain new and valuable insights
Hosted by:
Uwe Gudat
Head of Safety Biosimilars
Merck Serono

Event Type: Other Scientific Events
Organization: CAAT, US FDA, NIEHS, NIH, and US EPA
Event Title: Workshop on Systematic Review: What is Systematic Review? An Introductory Course
Event Date or Start Date: 3/9/2015
End Date: 3/9/2015
Country: UNITED STATES
State or Region: MD
Meeting Web Site: www.surveymonkey.com/r/GYGDBM9
Additional Meeting Information: News from the Johns Hopkins Center for Alternatives to Animal Testing (CAAT) Workshop on Systematic Review: What is Systematic Review? An Introductory Course Organized by CAAT, FDA, NIEHS, NIH, and EPA March 9, 2015 • 9am-12:30pm College Park, Maryland Systematic review and related evidence-based approaches are beginning to be translated from healthcare to toxicology. They provide transparent, objective, and consistent tools to identify, select, appraise, and extract evidence across studies. Systematic review methodologies provide objectivity and transparency to the process of collecting and synthesizing scientific evidence in reaching conclusions on specific research questions. Procedures are explicitly defined in advance, in order to ensure that the exercise is transparent and can be replicated. This practice is also designed to minimize bias. Systematic review procedures are being adopted by other federal agencies, including US EPA and NIEHS.

Studies included in a systematic review are screened for quality, so that the findings of a large number of studies can be combined.

Event Type: Other Scientific Events
Organization: GCPseminars
Event Title: GCPseminars Workshop on HIPAA 2015—Upcoming Changes
Event Date or Start Date: 3/5/2015
End Date: 3/6/2015
Country: UNITED STATES
State or Region: MD
Meeting Web Site: https://www.gcpseminars.com
Additional Meeting Information: We will be discussing some of the changes taking place in Washington with the Health and Human Services in regards to the enforcement of the HIPAA laws already on the books and also touching on some of the risks for business associates.

I will go over the new changes for 2015 affecting covered entities and business associates. I will also be discussing factors might cause an unwanted visit or letter from the Office of Civil Rights and how to prepare for the audit and deal with the Feds.

Why should you attend:

  • What’s going on in the world of HIPAA at 2015?
  • Have you proactively prepared your practice or business?
  • Why has it taken so long for enforcement and why is it all of a sudden happening?
  • How can you limit risks of an audit?
  • What factors may cause a HIPAA audit?

Areas Covered in the Session:

  • HIPA A 2015—what’s new
  • How to reduce risk
  • What factors may prompt an OCR audit
  • HIPAA a History
  • Who will benefit:

    • Practice Managers
    • Compliance Officers
    • Any business associates privy to private health information and under the auspices of this law

    Agenda

    Day One

    Lecture 1: HIPAA - History
    Lecture 2: HIPAA Privacy Rule vs HIPAA Security Rule
    Lecture 3: HITECH Act
    Lecture 4: Breach Notification Rule
    Lecture 5: Omnibus Rule
    Lecture 6: Business Associates
    Lecture 7: Current Court Cases (precedence)
    Lecture 8: Paper Based PHI Concerns
    Lecture 9: Disaster Recovery Concerns (Paper)
    Lecture 10: Psych and Infectious Disease

    Day Two

    Lecture 1: How to Conduct a Risk Assessment
    Lecture 2: How to Write Policies and Procedures
    Lecture 3: Choosing a HIPAA Consultant
    Lecture 4: Choosing an IT Group
    Lecture 5: Disaster Recovery Concerns (Electronic)
    Lecture 6: Physical Setup
    Lecture 7: What the Feds are Looking For (low hanging fruit)
    Lecture 8: What are Factors That Can Get Your Practice Audited
    Lecture 9: State Laws and Patient Ability to Sue

    Speaker:

    Brian L Tuttle is a Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified Business Resilience Auditor (CBRA) with over 15 years experience in Health IT and Compliance Consulting. Mr. Tuttle has worked all of those 15 years with MAG Mutual Healthcare Solutions and is now Senior Compliance Consultant and IT Manager with InGauge Healthcare Solutions (previously named MAG Mutual Healthcare Solutions).


    Event Type: Other Scientific Events
    Organization: GCPseminars
    Event Title: GCPseminars Workshop on Marketing Products Without Getting Hammered by US FDA
    Event Date or Start Date: 3/5/2015
    End Date: 3/6/2015
    Country: UNITED STATES
    State or Region: MD
    Meeting Web Site: www.gcpseminars.com
    Additional Meeting Information: With this seminar you will learn how to navigate US FDA’s legal requirements and its interpretations for enforcement purposes.

    The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA’s legal corral.

    This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to US FDA enforcement. Most importantly, you will understand the boundaries that the US FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm’s regulatory profile for advertising and promotion.


    Event Type: Other Scientific Events
    Organization: GCPseminars
    Event Title: GCPseminars Workshop on Clinical Drug Development and Approval Process
    Event Date or Start Date: 3/5/2015
    End Date: 3/6/2015
    Country: UNITED STATES
    State or Region: MD
    Meeting Web Site: https://www.gcpseminars.com
    Additional Meeting Information: Drug development is the process of incorporating data from multiple disciplines into a logical and coherent argument for the efficacy and safety of a drug product resulting in regulatory approval.

    The course will focus on the clinical aspect.

    The primary goal of the course will provide students with the basic principles and process for taking a chemical and developing it into a drug product. Medical, pharmaceutical, pharmacokinetics, and statistical principles will be reviewed and utilized in the course. Examples will be provided by my experience, experiences in the literature, and approvals from the US Food and Drug Administration website.

    The outline for the class will include organization of a pharmaceutical company including preclinical, pharmaceutical development, clinical pharmacology, clinical, and regulatory. Several therapeutic areas will be used in examples. The valuable use of teams will be described by membership and responsibilities. Interactions with different drug company teams will be examined along with interaction with FDA teams.

    The stages of development (Phases 1–4) along with formal meetings with the US FDA along with important regulatory submissions (IND, Phase I, II, III, NDA) will be described and discussed.

    Importance of regulatory interaction will be described and discussed along with strategies for providing a successful outcome for both parties. While dynamic tension between the regulatory authority and the pharmaceutical company will occur, it can be used to provide the energy for generating a successful outcome. While the company develops the clinical strategy, the US FDA often provides changes that improve it. Reviews of real life drugs will be used as examples along with developing the prescribing information. Pharmacokinetic approaches will be described without the need for understanding the math. The use of pharmacokinetic information will be described.


    Event Type: Other Scientific Events
    Organization: GCPseminars
    Event Title: GCPseminars Workshop on Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Pharmaceutical Water Systems
    Event Date or Start Date: 3/5/2015
    End Date: 3/6/2015
    Country: SWITZERLAND
    State or Region: Zurich
    Meeting Web Site: www.gcpseminars.com
    Additional Meeting Information: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not necessary. The instructor can provide the background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system design and control are merely managed by a set of rules that often don''t work and can cause very costly system downtime or even product recalls.

    Why should you attend:

    (Fear, uncertainty and doubt (FUD) liner for the marketing purpose)—Are you having persistent water system problems —nothing you do seems to help for very long if at all? Are your water systems excursion investigations always inconclusive because you can never confirm the original out-of-limit result and the bad results come and go? Are you concerned that US FDA will not think your water system validation was not stringent enough because of your current microbial problems? Are you afraid that biofilm has taken over and you can’t get rid of it?


    Event Type: Other Scientific Events
    Organization: GCPseminars
    Event Title: GCPseminars Workshop on The A to Z’s of HIPAA Privacy, Security, and Breach Notification Rules
    Event Date or Start Date: 3/5/2015
    End Date: 3/6/2015
    Country: UNITED STATES
    State or Region: AZ
    Meeting Web Site: https://www.gcpseminars.com
    Additional Meeting Information: This session is designed to provide intensive, two-day training in HIPAA compliance, including what’s new in the regulations, what’s changed recently, and what needs to be addressed for compliance by covered entities and business associates.

    The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate.

    Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided.

    Who Will Benefit:

    • Information Security Officers
    • Risk Managers
    • Compliance Officers
    • Privacy Officers
    • Health Information Managers
    • Information Technology Managers
    • Medical Office Managers
    • Chief Financial Officers
    • Systems Managers
    • Legal Counsel
    • Operations Directors
    • Physicians
    • Health Lawyers

    Agenda

    Day One

    Day one sets the stage with an overview of the HIPAA regulations and then continues with presentation of the specifics of the Privacy Rule, recent changes to the rules, and the basics of the Security Rule

    Lecture 1: Overview of HIPAA Regulations

    • The Origins and Purposes of HIPAA
    • Privacy Rule History and Objectives
    • Security Rule History and Objectives
    • Breach Notification Requirements, Benefits, and Results

    Lecture 2: HIPAA Privacy Rule Principles, Policies and Procedures

    • Patient Rights under HIPAA
    • Limitations on Uses and Disclosures
    • Required Policies and Procedures
    • Training and Documentation Requirements

    Lecture 3: Recent and Proposed Changes to the HIPAA Rules

    • New Penalty Structure
    • New HIPAA Audit Program
    • New Patient Rights
    • New Obligations for Business Associates

    Lecture 4: HIPAA Security Rule Principles

    • General Rules and Flexibility Provisions
    • The Role of Risk Analysis
    • Security Safeguards
    • Training and Documentation

    Day Two

    Day two begins with a detailed examination of HIPAA Security Rule requirements and what must be done to survive audits by the US Department of Health and Human Services, including an examination of how risk analysis can be used to drive compliance by the systematic examination of information flows and mitigation of risks discovered, and an exploration of the official HHS HIPAA Audit Protocol, including how to use the protocol to help manage your compliance work and its documentation.

    Finally, the day concludes with a session on the essential activities of documenting policies, procedures, and activities, training staff and managers in the issues and policies they need to know about, and examining compliance readiness through drills and self-audits.

    Lecture 5: HIPAA Security Policies and Procedures and Audits

    • HIPAA Security Policy Framework
    • Sample Security Policy Content
    • Recommended Level of Detail for Policies and Procedures
    • The New HIPAA Compliance Audit Protocol

    Lecture 6: Risk Analysis for Security and Meaningful Use

    Principles of Risk Analysis for Information Security Information Security Management Process Risk Analysis Methods Risk Analysis Example

    Lecture 7: Risk Mitigation and Compliance Remediation

  • Typical Security Risks
  • Social Media, Texting, email, and Privacy
  • Dealing with Portable Devices and Remote Access
  • Compliance Planning
  • Lecture 8: Documentation, Training, Drills and Self-Audits

    • How to Organize and Use Documentation to Your Advantage
    • Training Methods and Compliance Improvement
    • Conducting Drills in Incident Response
    • Using the HIPAA Audit Protocol for Documentation and Self-Auditing

    Speaker:

    Jim Sheldon-Dean is the founder and director of compliance services at Lewis Creek Systems, LLC, a Vermont-based consulting firm founded in 1982, providing information privacy and security regulatory compliance services to a wide variety of health care entities.

    Sheldon-Dean serves on the HIMSS Information Systems Security Workgroup, has co-chaired the Workgroup for Electronic Data Interchange Privacy and Security Workgroup, and is a recipient of the WEDI 2011 Award of Merit.

    Quick Contact:

    GCPseminars
    Support
    Toll free: +1.800.921.1537
    Fax: 302 288 6884

    Event Type: Other Scientific Events
    Organization: Massachusetts Society for Medical Research
    Event Title: IACUSs, IBCs, & IRBs: The 3 I's & Biosecurity...Compliant or Complacent?
    Event Date or Start Date: 3/4/2015
    End Date: 3/6/2015
    Country: UNITED STATES
    State or Region: NC
    Meeting Web Site: www.ncabr.org/researchers/conferences/3i/
    Additional Meeting Information: Massachusetts Society for Medical Research together with the FBI Weapons of Mass Destruction Directorate and the North Carolina Association for Biomedical Research, and recognized industry experts and compliance professionals will impart concrete strategies that will provide you a way to stay ahead of challenging regulatory and security issues.

    Panels and interactive discussion groups promise to offer a multifaceted learning experience!


    Event Type: Other Scientific Events
    Organization: GCPseminars
    Event Title: GCPseminars Workshop on Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Pharmaceutical Water Systems
    Event Date or Start Date: 3/2/2015
    End Date: 3/3/2015
    Country: UNITED STATES
    State or Region: CA
    Meeting Web Site: www.gcpseminars.com
    Additional Meeting Information: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not necessary. The instructor can provide the background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system design and control are merely managed by a set of rules that often don''t work and can cause very costly system downtime or even product recalls.

    Why should you attend:

    (Fear, uncertainty and doubt (FUD) liner for the marketing purpose)- Are you having persistent water system problems—nothing you do seems to help for very long if at all? Are your water systems excursion investigations always inconclusive because you can never confirm the original out-of-limit result and the bad results come and go? Are you concerned that FDA will not think your water system validation was not stringent enough because of your current microbial problems? Are you afraid that biofilm has taken over and you can’t get rid of it?


    Event Type: Other Scientific Events
    Organization: GCPseminars
    Event Title: 2-Day In-Person Seminar US FDA Device Software Regulation—2-day In-person Seminar
    Event Date or Start Date: 2/26/2015
    End Date: 2/27/2015
    Country: UNITED STATES
    State or Region: MA
    Meeting Web Site: https://www.gcpseminars.com
    Additional Meeting Information: Software’s level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles. Software may be a standalone device, control a device’s performance, make calculations, identify treatment options or begin to play a more active role in making clinical decisions regarding patient management and treatment. FDA’s risk classification will gradually clarify how it intends to manage the health risks.

    Software use has become increasingly complicated with the expansion of software applications, for example: cybersecurity, interoperability, and mobile medical.


    Event Type: Other Scientific Events
    Organization: GCPseminars
    Event Title: Supplier Management for Medical Device Manufacturers—2-day Comprehensive Workshop
    Event Date or Start Date: 2/26/2015
    End Date: 2/27/2015
    Country: UNITED STATES
    State or Region: MN
    Meeting Web Site: https://www.gcpseminars.com
    Additional Meeting Information: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the US FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment.

    How well do you understand the requirements for supplier management?

    Could you pass a regulatory audit or inspection without any issues?

    This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program.

    This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding.

    In addition, the course uses US FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers’ location, supplier auditing techniques, and supplier issues in management review.

    The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation.

    Quick Contact:

    GCPseminars
    Support
    Toll free: +1.800.921.1537 Fax: 302.288.6884

    Event Type: Other Scientific Events
    Organization: GCPseminars
    Event Title: Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Pharmaceutical Water Systems—In-person Training Workshop
    Event Date or Start Date: 2/26/2015
    End Date: 2/27/2015
    Country:
    State or Region:
    Meeting Web Site: www.gcpseminars.com
    Additional Meeting Information: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, although a plus, it is not necessary.

    The instructor can provide the background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system design and control are merely managed by a set of rules that often don’t work and can cause very costly system downtime or even product recalls.

    Quick Contact:

    GCPseminars
    Support
    Toll free: +1.800.921.1537 Fax: 302.288.6884


    Event Type: Webinars
    Organization: Society of Toxicology
    Event Title: CCT Webinar: Science-Based Decision-Making to Enhance Regulatory Success
    Event Date or Start Date: 2/25/2015
    End Date: 2/25/2015
    Country: UNITED STATES
    State or Region:
    Meeting Web Site: www.toxicology.org/ms/cctWebinars.asp#regulatory_toxicology
    Additional Meeting Information: Diversity is increasing in the biological targets, pharmacological strategies, and types of chemistry being investigated in first time in human (FTIH) studies; similarly, there is growing information, guidance, and experience to protect volunteer/patient safety. In response, regulatory toxicology strategies have diversified and evolved from those practiced only a decade ago reflecting advances in science and technology and the experiences of individuals and organizations. These webinars will address how we understand and work with this diversity both now and in the future to bring important new (and safer) medicines to patients.

    These webinars will focus on four key areas: small molecules, traditional biologics, innovative biologics, and nucleotide constructs. For each of these we will address the relevant aspects of science and technology, strategic and tactical issues (study design, species selection, target organ toxicity profiles), and regulatory guidance relevant to safety assessment, including approaches in rare diseases. There will also be a future focus as we consider new directions in the field, including reducing or moving away from animal testing. These webinars will be of broad interest to academic, industry, regulatory, and consultant toxicologists who wish to be updated in this critical and evolving area.

    Event Type: SOT Sponsored Non-SOT Meeting
    Organization: Society of Toxicology in conjunction with US FDA Center for Food Safety and Applied Nutrition
    Event Title: SOT FDA Colloquia: Application of ADME/PK Studies to Improve Safety Assessments for Foods and Cosmetics
    Event Date or Start Date: 2/23/2015
    End Date: 2/23/2015
    Country: UNITED STATES
    State or Region: MD
    Meeting Web Site: www.toxicology.org/ai/meet/fda/fdacolloquia022315.asp
    Additional Meeting Information: The focus of this colloquium is on the application of ADME/PK studies to improve safety assessments for foods and cosmetics. Pharmacokinetic data on the time-course of a chemical in the body can be used to support the key extrapolations that are typically necessary for chemical risk assessments. In the past, the primary concern has been to extrapolate the doses in animal studies showing effects to equivalent doses in the human. With the recent emphasis on in vitro-based risk assessment, pharmacokinetic information is now being used to support the extrapolation from media concentrations associated with effects in vitro to the equivalent in vivo dose. This colloquium will provide a synopsis of the current state of the art for the application of pharmacokinetic data and modeling to risk assessments for foods, food contaminants and cosmetic ingredients. Three case studies will be provided illustrating the process of incorporating pharmacokinetic data in risk assessments based either on traditional or emerging toxicity study approaches. A panel discussion will enhance interaction with the attendees.

    Event Type: Other Scientific Events
    Organization: Maarefah Management
    Event Title: Pharmaceutical Commercial Excellence MENA Congress
    Event Date or Start Date: 2/16/2015
    End Date: 2/19/2015
    Country: UNITED ARAB EMIRATES
    State or Region:
    Meeting Web Site: http://www.mepharmaexcellence.com/
    Additional Meeting Information: The Pharmaceutical Commercial Excellence MENA Congress will reflect the current market changes, impart new information and share peer-to-peerr experience on overcoming the most pressing issues facing pharmaceutical companies today. The congress will provide new strategies to increase commercial excellence, featuring plenary strategy sessions and two streams: Sales and Marketing Management and Human Resources and Leadership. This format will enable you to network with all leading pharmaceutical experts and understand the need for driving commercial excellence throughout your organization.

    Event Type: Annual Meeting
    Organization: Pharma IQ
    Event Title: Predictive Toxicology Summit 2015
    Event Date or Start Date: 2/16/2015
    End Date: 2/18/2015
    Country: UNITED KINGDOM
    State or Region:
    Meeting Web Site: www.predictivetoxicology.com/
    Additional Meeting Information: Pharma IQ’s Predictive Toxicology Summit is back, in its 7th year as an industry leading event specifically tailored to Predictive Toxicology.

    The power of predictive Toxicology is not to be underestimated as it is one of the most important stages in drug development, it reduces the number of late stage drug attrition by highlighting toxicity at an earlier stage in drug development.

    The 7th Annual Predictive Toxicology Summit is your tool kit to the forthcoming drug development year covering topics such as:

    • The transition of the Toxicology industry from animal models to human tissue models
    • The evolution of 3D Models
    • Stem cells
    • Biomarkers

    Event Type: Other Scientific Events
    Organization: SMi Group
    Event Title: Advances and Progress in Drug Design
    Event Date or Start Date: 2/16/2015
    End Date: 2/17/2015
    Country: UNITED KINGDOM
    State or Region: London
    Meeting Web Site: atnd.it/16012-0
    Additional Meeting Information:

    SMi are proud to present the 14th annual conference, Advances and Progress in Drug Design, taking place on February 16-17, 2015 in Central London.

    Hear case study driven presentations from an array of market leaders such as the University of Cambridge, Janssen, MedImmune, Sanofi and Novartis, discussing computational approaches, structure based drug design, pharmacokinetics, polypharmacology, drug metabolism and fragment based drug design, PLUS MUCH MORE!


    Event Type: Other Scientific Events
    Organization: GCPseminars
    Event Title: Safe Production of Meat Products—In-Person Comprehensive Workshop
    Event Date or Start Date: 2/12/2015
    End Date: 2/13/2015
    Country: UNITED STATES
    State or Region: MO
    Meeting Web Site: https://www.gcpseminars.com
    Additional Meeting Information: Educational material discussed during this seminar will include both effective sanitation and hygienic practices and the control of microorganisms that cause spoilage and food borne illness.

    After a discussion of microorganisms found in meat products, safety issues will be addressed and contamination sources identified. Practices to reduce contamination such as personal hygiene and Good Manufacturing Practices (GMPs) will be discussed. Sanitation procedures for cleaning after production will be provided and the identification of the optimal cleaning compounds and sanitizers will be addressed. Furthermore, viable sanitation equipment and updated food safety technologies will be identified.

    Quick Contact:

    GCPseminars
    Support
    Toll free: +1.800.921.1537
    Fax: 302.288.6884

    Event Type: Other Scientific Events
    Organization: SMi Group Ltd
    Event Title: Parallel Trade
    Event Date or Start Date: 2/9/2015
    End Date: 2/10/2015
    Country: UNITED KINGDOM
    State or Region: London
    Meeting Web Site: atnd.it/16126-1
    Additional Meeting Information: Different regulatory regimes for pharmaceuticals result in significant differences in pharmaceutical prices across countries. These prices make it profitable for parallel trade to take place in addition to it reaching a significant proportion of total national pharmaceutical expenditure in many European countries. The issue of pharmaceutical parallel trade continues to generate controversy among stakeholders and has become an issue of intense debate in the global trading system.

    Event Type: Other Scientific Events
    Organization: Agency for Toxic Substance and Disease Registry (ATSDR)
    Event Title: A Story of Health
    Event Date or Start Date: 2/9/2015
    End Date: 2/27/2015
    Country: UNITED STATES
    State or Region:
    Meeting Web Site: www.bht1@cdc.gov
    Additional Meeting Information: When a disease or health disorder occurs, people often ask their health care providers, “How did this happen?” A Story of Health multi-media eBook explores this question and delves into how our environments interact with our genes to influence health across the lifespan. A Story of Health is told through the lives of fictional characters and their families—Brett, a young boy with asthma; Amelia, a teenager with developmental disabilities; and toddler Stephen, recently diagnosed with leukemia. Each fictional case features the latest scientific research about disease origin and helpful facts about disease prevention. “Although our characters are fictional, the risk factors they face are real,” says Mark Miller MD, MPH, co-author and director of the University of California, San Francisco, Pediatric Environmental Health Specialty Unit. “Our eBook brings stories of health to life through an interactive format that we believe will engage a wide range of audiences.”

    Colorful illustrations, graphics and videos enhance each page. Links to a wide range of additional resources and hundreds of scientific papers enrich each story with information you can use today to promote health and prevent disease. A Story of Health is useful to readers ranging from health professionals to health advocates, from policymakers to those in the health and science media. The eBook offers FREE continuing education credits through the Centers for Disease Control and Prevention (CDC)/the Agency for Toxic Substances and Disease Registry (ATSDR).

    A Story of Health was developed by ATSDR, the Collaborative on Health and the Environment (CHE), the University of California, San Francisco, Pediatric Environmental Health Specialty Unit (UCSF PEHSU), the Office of Environmental Health Hazard Assessment, California EPA (OEHHA), and the Science and Environmental Health Network (SEHN).

    Access and


    Event Type: Other Scientific Events
    Organization: GCPseminars
    Event Title: Clinical Drug Development—In-Person Training Workshop
    Event Date or Start Date: 2/5/2015
    End Date: 2/6/2015
    Country: UNITED STATES
    State or Region: MD
    Meeting Web Site: https://www.gcpseminars.com
    Additional Meeting Information: Drug development is the process of incorporating data from multiple disciplines into a logical and coherent argument for the efficacy and safety of a drug product resulting in regulatory approval.

    This course will focus on the clinical aspect. The primary goal of the course will provide students with the basic principles and process for taking a chemical and developing it into a drug product. Medical, pharmaceutical, pharmacokinetics, and statistical principles will be reviewed and utilized in the course. Examples will be provided by my experience, experiences in the literature, and approvals from the US Food and Drug Administration website.

    Quick Contact:

    GCPseminars
    Support
    Toll free: +1.800.921.1537
    Fax: 302.288.6884


    Event Type: Other Scientific Events
    Organization: GTCbio
    Event Title: 13th Cytokines & Inflammation
    Event Date or Start Date: 1/29/2015
    End Date: 1/30/2015
    Country: UNITED STATES
    State or Region: CA
    Meeting Web Site: www.gtcbio.com/conferences/cytokines-inflammation-overview
    Additional Meeting Information: GTCbio’s Cytokines & Inflammation Conference has become an established meeting point for academic scientists, industry clinical developers, and government researchers to discuss complementary approaches in the field of cytokine biology. We are excited to announce the 13th annual edition of this meeting, so mark your calendars and save the date!

    Some focused topics we will discuss this meeting include developments in the therapeutic application of cytokines and proposal of new targets, the complex relationship between the immune system and microbes in the homeostasis of mucosal tissues, new findings in the biology and regulation of IL–23 and IL–17, novel means to modulate immune pathways to promote anti-tumor activity, and many more.


    Event Type: Other Scientific Events
    Organization: GTCbio
    Event Title: 7th Immunotherapeutics & Immunomonitoring Conference
    Event Date or Start Date: 1/29/2015
    End Date: 1/30/2015
    Country: UNITED STATES
    State or Region: CA
    Meeting Web Site: www.gtcbio.com/conferences/immunotherapeutics-immunomonitoring-overview
    Additional Meeting Information: Leading experts from the scientific and clinical arenas and industry will present about novel findings and developments in the constantly changing area of immunological assays and procedures. They will also discuss recent advances in immunotherapy, as they relate to various immunotherapy modalities, specific cancers, cell subsets, animal models, and tumor microenvironment. Potential clinical feasibility and commercial potential of the newest data obtained from leading biomedical research laboratories will also be discussed.

    Network with colleagues to discuss: An update on state-of-the-art immunomonitoring, Novel strategies to identify and validate biomarkers predictive for clinical efficacy, Novel strategies to identify and clinically develop synergistic combination therapies, and outlook on novel druggable targets for immunotherapy.


    Event Type: Other Scientific Events
    Organization: GTCbio
    Event Title: 3rd Immunogenicity and Immunotoxicity Conference
    Event Date or Start Date: 1/29/2015
    End Date: 1/30/2015
    Country: UNITED STATES
    State or Region: CA
    Meeting Web Site: www.gtcbio.com/conferences/immunogenicity-immunotoxicity-overview
    Additional Meeting Information: GTC is proud to announce its 3rd Immunogenicity and Immunotoxicity Conference, one of four parallel tracks to the Novel Immunotherapeutics Summit 2015 in San Diego, California.

    The conference will cover important progress made in the areas of therapeutic protein immunogenicity and immunotoxicity evaluation such as protein aggregation, clinical relevance and assessment of immunogenicity, mitigation of immunogenicity-related risks, biosimilar development, and immunotoxicity evaluation strategies.

    The Immunogenicity and Immunotoxicity Conference will provide guests with a better understanding of the ongoing research for tools to mitigate risks associated with the immunogenicity of therapeutic proteins. Guests will get an up-to-date understanding of the mechanisms and consequences of protein aggregation and insights on how to prosecute state-of-the-art assessment of the clinical immunogenicity of therapeutic proteins.

    Event Type: Other Scientific Events
    Organization: GTCbio
    Event Title: Novel Immunotherapeutics Summit
    Event Date or Start Date: 1/29/2015
    End Date: 1/30/2015
    Country: UNITED STATES
    State or Region: CA
    Meeting Web Site: www.gtcbio.com/conferences/immunotherapeutics-summit-overview
    Additional Meeting Information: The Summit will begin with a plenary keynote session—then break into four concurrent conferences, all of which will talk about complementary areas of the latest breakthroughs in the immunology field.

    Event Type: Other Scientific Events
    Organization: ExL Pharma
    Event Title: 4th Drug Formulation and Bioavailability
    Event Date or Start Date: 1/26/2015
    End Date: 1/28/2015
    Country: UNITED STATES
    State or Region: MA
    Meeting Web Site: atnd.it/17056-0
    Additional Meeting Information: The 4th annual Drug Formulation and Bioavailability conference is the leading industry event where experts in formulation, preformulation, pharmaceutics, and PKDM share best practice in optimizing drug solubility, permeability, and delivery improvements, accelerating time-to-market, and extending the product life cycle. This year’s program features an all-new agenda based around long standing specific requests from our audience. With three days of programming, two interactive workshops, four all-new tracks, over six hours of networking, and two-dozen speakers, this is the event you must attend to overcome ever-changing technical and regulatory obstacles to drug development and delivery!

    Event Type: Other Scientific Events
    Organization: SMi Group Ltd
    Event Title: Pharmaceutical Microbiology: Excellence in the Prevention, Detection and Management of Microorganisms
    Event Date or Start Date: 1/21/2015
    End Date: 1/22/2015
    Country: UNITED KINGDOM
    State or Region: London
    Meeting Web Site: www.smi-online.co.uk/goto/2015pharma-microbiology51.asp
    Additional Meeting Information:

    The 4th annual event in the sell-out Pharmaceutical Microbiology series will bring together all levels of industry professionals, providing essential insights into the latest advancements in practice and technology, developments in regulation and the global harmonisation of evolving microbiology methods.

    Join us as we ask questions such as: What are the best approaches in contamination control? Where does microbiological risk assessment interact with HACCP? How do we develop and manage the sterilisation and validation process? When can we use a scoring system to avoid unnecessary microbiological testing? What are the latest approaches to preventing biofilms?

    Hear presentations from an array of market leaders such as GSK, Genzyme, Abbott, MedImmune and AstraZeneca, address real world case studies on the benefits and challenges of rapid methods, risk assessments and objectionable organisms.

    Alternatively contact the team via phone at +44 (0) 870 9090 711 or email events@smi-online.co.uk


    Event Type: Other Scientific Events
    Organization: Management Forum Ltd
    Event Title: Borderline Between Medicines and Food
    Event Date or Start Date: 12/12/2014
    End Date: 12/12/2014
    Country: UNITED KINGDOM
    State or Region: London
    Meeting Web Site: atnd.it/17093-0
    Additional Meeting Information: Medicines treat, cure or prevent illness. Foods provide nutrition, but are the distinctions so clear. Foods also have a physiological effect and a role in disease risk reduction - and substances whose purpose is nutritional may be presented as medicines. An understanding of where the borderline lies between medicines and foods is essential for the successful marketing of specialist health products; getting it wrong is a costly route to market failure. However, the regulatory framework is detailed and complex, requiring a knowledge of the relevant legislation. By addressing these topics, this seminar aims to assist delegates to an understanding of how the borderline may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them.

    Event Type: Other Scientific Events
    Organization: SMI Group Ltd
    Event Title: ADCs from early development to the clinic
    Event Date or Start Date: 12/9/2014
    End Date: 12/9/2014
    Country: UNITED KINGDOM
    State or Region: London
    Meeting Web Site: atnd.it/14453-0
    Additional Meeting Information: This Masterclass will provide the top view for all disciplines and functions including discovery, manufacturing, nonclinical, regulatory and clinical.

    ADCs and next generation drug conjugates are the most exciting advances in therapeutic drug development. Progressing development is complex process as targeting molecule, linker and war head all have to be assessed for safety. This depends on using different approaches to find the best options and progress quickly to first-time in human studies (FTIH). The risks needs to be managed to reach objectives and plans set in place to deal with the unexpected. The outcome is to provide an agency with a credible CMC package, demonstrable efficacy and safety to support a risk management plan for FTIH. The Masterclass aims to cover the most important aspects that should be part of the

    Event Type: Other Scientific Events
    Organization: SMi Group Ltd
    Event Title: ADCs from early development to the clinic
    Event Date or Start Date: 12/9/2014
    End Date: 12/9/2014
    Country: UNITED KINGDOM
    State or Region: London
    Meeting Web Site: atnd.it/14453-0
    Additional Meeting Information: ADCs and next generation drug conjugates are the most exciting advances in therapeutic drug development. Progressing development is complex process as targeting molecule, linker and war head all have to be assessed for safety. This depends on using different approaches to find the best options and progress quickly to first-time in human studies (FTIH). The risks needs to be managed to reach objectives and plans set in place to deal with the unexpected. The outcome is to provide an agency with a credible CMC package, demonstrable efficacy and safety to support a risk management plan for FTIH. The Masterclass aims to cover the most important aspects that should be part of the "big picture" to file an IND.

    This Masterclass will provide the top view for all disciplines and functions including discovery, manufacturing, nonclinical, regulatory and clinical to provide each with the challenges faced by the other disciplines.

    Event Type: Other Scientific Events
    Organization: SMI Group Ltd
    Event Title: Mastering Clinical Trial Documents
    Event Date or Start Date: 12/9/2014
    End Date: 12/9/2014
    Country: UNITED KINGDOM
    State or Region:
    Meeting Web Site: atnd.it/14200-0
    Additional Meeting Information: This full-day masterclass (comprising interactive seminars, discussions, and group activities) will outline the regulations that relate to Trial Master Files (including best practice guidance and the latest thinking from the European Medicines Agency) and explain how clinical study records can be created and managed to ensure the timely availability of an inspection-ready TMF.

    Event Type: Other Scientific Events
    Organization: SMI Group Ltd
    Event Title: ADME for the Medicinal Chemist
    Event Date or Start Date: 12/5/2014
    End Date: 12/5/2014
    Country: UNITED KINGDOM
    State or Region: London
    Meeting Web Site: atnd.it/14225-0
    Additional Meeting Information:

    ADME and toxicology testing, is the fastest moving subsegment of cell-based assay and a critical component to drug development, growing at a tremendous CAGR of 15%. This segment is expected to reach a global value of nearly $4.6 billion in 2018.

    This masterclass will give an overview of the ADME process and covers concepts such as solubility, permeability, Pgp, CYP 450s, Phase 1 & 2 metabolism, glomerular filtration and enteropathic cycling. It demystifies pharmacokinetic terms such as t1/2, clearance and volume of distribution.

    The sessions will place heavy emphasis on the use of current medicinal chemistry literature to solve recurrent ADME issues. Using the succeed through the literature approach participants will distil out working solutions to issues such as solubility, oral absorption, CNS penetration and duration of action.


    Event Type: Other Scientific Events
    Organization: GlobalCompliancePanel
    Event Title: Applied Statistics for QA, QC, Manufacturing, and Design Control
    Event Date or Start Date: 12/4/2014
    End Date: 12/5/2014
    Country: UNITED STATES
    State or Region: CA
    Meeting Web Site: www.globalcompliancepanel.com/seminar
    Additional Meeting Information: The 2-day seminar begins with an examination of ISO and US FDA regulations and guidelines regarding the use of statistics. Basic vocabulary and concepts are then reviewed and discussed. The flow of subsequent topics over the 2 days is as follows:

    - How to calculate confidence intervals (for proportions and for measurements), including a discussion of how to choose sample size - How to perform an interpret t-Tests, including consideration of

    Event Type: Other Scientific Events
    Organization: Informa IIR Ltd
    Event Title: The Developmentment & Manufacturing of Vaccines Conference 2014
    Event Date or Start Date: 12/3/2014
    End Date: 12/4/2014
    Country: BELGIUM
    State or Region:
    Meeting Web Site: atnd.it/15538-0
    Additional Meeting Information: Informa Life Sciences Development & Manufacturing of Vaccines conference will provide you with crucial insight into the future of the field for both large pharma and SMEs and will offer you plenty.

    Event Type: Other Scientific Events
    Organization: Management Forum Ltd
    Event Title: An Introduction to the Medical Device Directives
    Event Date or Start Date: 12/3/2014
    End Date: 12/5/2014
    Country: UNITED KINGDOM
    State or Region:
    Meeting Web Site: atnd.it/17090-0
    Additional Meeting Information: This seminar provides a detailed introduction to the European Medical Device Legislation. It will explain the Directives and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do. It will also cover the documentation necessary to apply for the CE Mark.

    Event Type: Other Scientific Events
    Organization: SMI Group Ltd
    Event Title: Quantitative Benefit Risk Assessment for the New PSUR & Risk Minimisation
    Event Date or Start Date: 12/2/2014
    End Date: 12/2/2014
    Country: UNITED KINGDOM
    State or Region:
    Meeting Web Site: atnd.it/14392-0
    Additional Meeting Information: Quantitative Benefit Risk Assessment will be hosted by OXON Epidemiology Ltd. OXON is a consultancy and CRO that specialises in real word data: Epidemiology (field and database studies and patient registries), Safety (PASS studies, statistical signal analysis, benefit-risk analysis, risk management), HEOR, Meta-analysis, development of concept protocols, and Evidence strategy for pre-and post-approval products.

    The masterclass will provide attendees with the necessary exposure to approach the elements of benefit-risk analysis for the new PSUR in their company for new and old drugs, and approaches to evaluate the positive and negative effects of risk minimisation measures.

    Event Type: Other Scientific Events
    Organization: SMI Group Ltd
    Event Title: Adaptive Designs: Concepts and Practical Considerations for Implementation
    Event Date or Start Date: 12/2/2014
    End Date: 12/2/2014
    Country: UNITED KINGDOM
    State or Region:
    Meeting Web Site: atnd.it/14195-1
    Additional Meeting Information: This course will present key concepts in clinical trial designs, different types of design options (with a focus on adaptive designs), and their benefits as well as possible complexities. The trainer will employ East software as a design interface, demonstrating how the clinical team can visualize and evaluate the key operating characteristics of a design. Where ever possible, case examples from recent clinical trials will be used to help illustrate concepts and real-world application of the designs.

    This workshop is intended for medical officers, biostatisticians, and core members of the clinical team who would like to better understand the range of trial designs available to them, and which are accepted by regulators. It will enable them to look beyond off-the-shelf designs and to consider options which would allow for patient savings, built-in flexibility, improved knowledge-return from a study, and an earlier time-to-market. The workshop will also inform the participants about methods they can use to better forecast the outcomes of a trial, and monitoring tools that can help them plan or adjust to trial changes.

    Event Type: Other Scientific Events
    Organization: DIA Europe
    Event Title: Biosimilars Conference
    Event Date or Start Date: 12/2/2014
    End Date: 12/3/2014
    Country: GERMANY
    State or Region:
    Meeting Web Site: atnd.it/11026-0
    Additional Meeting Information: One year further into Biosimilars, this 2-day conference will provide an update on the current status for biosimilars in EU. The conference will give an overview of the current regulatory, scientific and market perspectives for biosimilars, including discussion on a number of Hot Topics in the field. In addition to plenary lectures with panel discussions the conference will include interactive break-out sessions providing participants an opportunity to bring forward their own experience and share their thoughts and ideas with the experts.

    Event Type: Other Scientific Events
    Organization: SMI Group Ltd
    Event Title: 9th annual Cold Chain Distribution Conference and Exhibition
    Event Date or Start Date: 12/2/2014
    End Date: 12/3/2014
    Country: UNITED KINGDOM
    State or Region:
    Meeting Web Site: atnd.it/12849-0
    Additional Meeting Information: Join this event and be part of a major networking opportunity providing intimate interaction with your peers, where you will hear case studies, presentations and round table discussions on the key issues surrounding the global healthcare cold chain distribution process and logistic requirements for various temperature sensitive healthcare products. on Tuesday December 02, 2014 at 8:30 am (ends Wednesday December 03, 2014 at 5:00 pm) Venue: Marriott Regents Park Hotel, 128 King Henry''s Road, London, NW3 3ST

    Event Type: Other Scientific Events
    Organization: United States Government
    Event Title: Environmental Justice Panel
    Event Date or Start Date: 12/2/2014
    End Date: 12/2/2014
    Country: UNITED STATES
    State or Region: Washington, D.C.
    Meeting Web Site:
    Additional Meeting Information: "Over 40 After the passage of the Clean Air Act and Clean Water ACT: How Communities of color are still facing unequal health burdens"

    Honorary Host: Rep. Barbara Lee, Rep. Mike Honda, Rep. Raul Grijalva, and Rep. Keith Ellison invite you to please join in a briefing from leading environmental organizations to discuss how African American, Latino, Asian Pacific Islander and Native American communities still suffer from disproportionate amounts of pollution and health disparities.

    When: Tuesday, December 2, 2014
    Time: 3:00pm–4:30pm
    Where: 121 Cannon House Office Building; Washington DC

    Sponsored by the Public Health Institute
    In conjunction with the Congressional Progressive Caucus (CPC)


    Event Type: Other Scientific Events
    Organization: UBM
    Event Title: CPhI and P-MEC India 2014
    Event Date or Start Date: 12/2/2014
    End Date: 12/4/2014
    Country: INDIA
    State or Region:
    Meeting Web Site: atnd.it/17020-0
    Additional Meeting Information: CPhI, P-MEC, ICSE and BioPh India form the country''s largest and leading pharma event. CPhI and P-MEC India: the no. 1 South Asian Pharma sourcing event. Meet the movers and shakers in India's pharma.

    Event Type: Other Scientific Events
    Organization: Management Forum Ltd
    Event Title: Pharmacovigilance
    Event Date or Start Date: 12/1/2014
    End Date: 12/3/2014
    Country: UNITED KINGDOM
    State or Region: London
    Meeting Web Site: atnd.it/17089-0
    Additional Meeting Information:

    A basic training for those working on Drug Safety monitoring in the EU, USA and JAPAN.

    Key Topics to be discussed at this conference:

    • Principles of Pharmacovigilance and Data Resources
    • Risk Management and Risk Minimisation
    • Causality Assessment: Clinical Diagnosis of Adverse Events
    • PASS and PAES studies
    • Regulatory Framework
    • European Post-Marketing Pharmacovigilance Regulations
    • Pharmacoepidemiological Studies
    • Evolution of PSURs, PBRERs, DSURs
    • Pro-active Pharmacovigilance Pre- and Post-Marketing
    • Clinical Trial ADR reporting requirements
    • Risk/Benefit Analysis
    • Drug Surveillance in countries outside Europe
    • Post-marketing Surveillance: Observational Cohort Studies
    • Introduction to Signal detection
    • Introduction to Risk Management plans
    • Practical Pharmacovigilance Workshop

    Speakers: Professor Saad Shakir Drug Safety Research Unit, Shelley Ghandi NDA Regulatory Science Ltd, Dr. John Talbot University of Hertfordshire, Dr. John Parkinson CPRD Consultant Expert, Dr. Glyn BelcherPV Consultancy Ltd


    Event Type: Other Scientific Events
    Organization: Informa IIR
    Event Title: EuroPeptides 2014
    Event Date or Start Date: 11/18/2014
    End Date: 11/19/2014
    Country: GERMANY
    State or Region: Berlin
    Meeting Web Site: atnd.it/13528-2
    Additional Meeting Information: Key Highlights for 2014- Latest Developments in Peptides
    • Enhance your understanding of new formulation strategies that exploit routes of administration.
    • Discover the latest clinical and preclinical program updates.
    • Uncover the cutting edge developments in macrocyclic and constrained peptides.
    • Evaluate new techniques to improve solid phase peptide synthesis including microwave-assisted SPPS and optimise large scale peptide manufacturing.
    • Optimise your manufacturing and analytical strategy to ensure successful and cost-effective process development stages.
    • Identify promising novel targets and indications outside of diabetes to help the expansion of pipelines in drug development.
    • Explore alternative methods to improve the half life capabilities of your peptide product.

    Event Type: Other Scientific Events
    Organization: Informa Life Sciences
    Event Title: Biosimilars and Biotech in Turkey and MENA
    Event Date or Start Date: 11/18/2014
    End Date: 11/19/2014
    Country: TURKEY
    State or Region:
    Meeting Web Site: atnd.it/14443-0
    Additional Meeting Information: Informa Life Sciences’ Biosimilars in Turkey and MENA conference features more industry case studies than any other conference, we offer you presentations from major biopharmaceutical companies including, Sandoz, Sanofi, Hikma, Abdi Ibrahim, Jordan Pharmaceutical Manufacturing company, CinnaGen Co plus many more.

    Time: 9:00 am–5:00 pm

    Venue details: Radisson Blu Istanbul Sisli, 19 Mayis Cad.N 2, Istanbul, 34360, Turkey

    Event Type: Other Scientific Events
    Organization: Maarefah Management
    Event Title: Middle East Pharma Cold Chain Congress
    Event Date or Start Date: 11/17/2014
    End Date: 11/20/2014
    Country: UNITED ARAB EMIRATES
    State or Region:
    Meeting Web Site: www.pharmacoldchainme.com/
    Additional Meeting Information: The combined growth of the biopharmaceutical industry and the globalization of the industry where the products needs to be transported from the origin to the destination at different points requiring controlled temperature to ensure the quality and safety of the products has resulted in numerous challenges for pharmaceutical professionals involved in their procurement, distribution and quality, therefore it is mandatory to understand the best practices for distribution of temperature sensitive products.

    This is especially important to the GCC as most temperature-sensitive pharmaceuticals are imported and due to the GCC experiencing massive air-cargo growth. It is also imperative that all stakeholders work in closer unison to achieve as few stalls and gaps as possible ensuring a smooth flow from factory to end user thus mitigating risk and ensuring patient safety.

    The Middle East Pharma Cold Chain Congress will address the challenges faced by the cold chain industry in the MENA region and their solutions, the establishment of quality distribution and risk management process and an in depth analysis on the latest Global Distribution Practices for temperature sensitive products.

    Event Type: Other Scientific Events
    Organization: Cambridge Healthtech Institute
    Event Title: Functional Analysis & Screening Technologies Congress
    Event Date or Start Date: 11/17/2014
    End Date: 11/19/2014
    Country: UNITED STATES
    State or Region: MA
    Meeting Web Site: www.fastcongress.com
    Additional Meeting Information: Join 250+ R&D teams dedicated to improving the screening success rates of drugs at 6 conferences: Phenotypic Drug Discovery (Part I & II), Engineering Functional 3D Models, Screening and Functional Analysis of 3D Models, Organotypic Culture Models for Toxicology and Physiologically-Relevant Cellular Tumor Models for Drug Discovery.

    Event Type: Regional Chapter
    Organization: Lone Star Regional Chapter
    Event Title: Lone Star RC Fall Meeting
    Event Date or Start Date: 11/13/2014
    End Date: 11/14/2014
    Country: UNITED STATES
    State or Region: TX
    Meeting Web Site: www.toxicology.org/isot/rc/lssot/meetings.asp
    Additional Meeting Information: “Environmental Influences on the Immune System”

    Event Type: Other Scientific Events
    Organization:
    Event Title: International Conference on Reproductive Biology and Toxicology 2014
    Event Date or Start Date: 11/10/2014
    End Date: 11/11/2014
    Country: BRAZIL
    State or Region: Ribeirao Preto, SP, Brazil
    Meeting Web Site: www.crbt2014.com.br
    Additional Meeting Information: The theme of the meeting is: “Reproduction and the Environment” and me main goals are as follows:
    • To offer to the participants, especially the Brazilian reproductive biologists and toxicologists, an opportunity for professional updates in the field, and to discuss their data with international experts during the presentation of abstracts in the Platform and Poster Sections.
    • To enhance collaboration among International and Brazilian Societies on Reproductive Biology.
    • To augment student participation in reproductive sciences and enhance student engagement in the field.

    Event Type: Annual Meeting
    Organization: GTCbio
    Event Title: XY Congress
    Event Date or Start Date: 11/6/2014
    End Date: 11/7/2014
    Country: UNITED STATES
    State or Region: CA
    Meeting Web Site: www.gtcbio.com/conferences/xy-congress-venue
    Additional Meeting Information: This summit includes two parallel conferences focused on the research and drug discovery of female specific and male specific oncology. Representatives from big pharma, academic institutions and government research labs will present data and case studies on key topics such as breast cancer diagnostics and therapeutics, prostate cancer diagnostics and therapeutics, PARP inhibitors, and cancer vaccines. Attend to learn and network with key opinion leaders in a highly interactive and intimate environment.

    Event Type: Other Scientific Events
    Organization: Management Forum Ltd
    Event Title: Inhaled Drug Delivery
    Event Date or Start Date: 11/5/2014
    End Date: 11/6/2014
    Country: UNITED KINGDOM
    State or Region: London
    Meeting Web Site: atnd.it/13909-0
    Additional Meeting Information: Developments and Innovations in Drugs for Inhalation. The conference will be chaired by Dr Steve Nichols, OINDP Specialist Consultant. Keynote Address COPD: New Drug Developments by Professor Peter Barnes National Heart and Lung Institute.

    Event Type: Other Scientific Events
    Organization: National Research Council
    Event Title: Emerging Science for Environmental Health Decisions Workshop Series, Modeling the Health Risks of Climate Change
    Event Date or Start Date: 11/3/2014
    End Date: 11/4/2014
    Country: US
    State or Region: DC
    Meeting Web Site: nas-sites.org/emergingscience/cchealthrisks/
    Additional Meeting Information: Register now to join the National Research Council’s Emerging Science for Environmental Health Decisions for a workshop on “Modeling the Health Risks of Climate Change.” Climate change poses a multitude of risks to human health and wellbeing through shifting conditions including more frequent and intense heatwaves and other extreme weather events, ocean acidification, and rising sea levels. This workshop will examine the current state-of-development of models that project the future health risks of climate change, and explore new methods to integrate health risks into models of the aggregated impacts of climate change. The event will be held at The Pew Charitable Trusts D.C. Conference Center, 901 E Street, NW, The Americas Room, Washington, D.C and will also be webcast.

    Event Type: Other Scientific Events
    Organization: The National Academy of Sciences
    Event Title: Emerging Science Workshop: Modeling the Health Impacts of Climate Change
    Event Date or Start Date: 11/3/2014
    End Date: 11/4/2014
    Country: UNITED STATES
    State or Region: DC
    Meeting Web Site: nas-sites.org/emergingscience/cchealthrisks/
    Additional Meeting Information: Register now to join the National Research Council’s Emerging Science for Environmental Health Decisions for a workshop on “Modeling the Health Risks of Climate Change.”

    Climate change poses a multitude of risks to human health and wellbeing through shifting conditions including more frequent and intense heatwaves and other extreme weather events, ocean acidification, and rising sea levels. This workshop will examine the current state-of-development of models that project the future health risks of climate change, and explore new methods to integrate health risks into models of the aggregated impacts of climate change.

    Event Type: Webinars
    Organization: Occupational and Public Health Specialty Section
    Event Title: Addressing Human Variability In Next-Generation Human Health Risk Assessments of Environmental Chemicals
    Event Date or Start Date: 10/31/2014
    End Date: 10/31/2014
    Country: UNITED STATES
    State or Region:
    Meeting Web Site: aim-hq.webex.com/aim-hq/onstage/g.php?d=732598837&t=a
    Additional Meeting Information: Topic: Addressing Human Variability In Next-Generation Human Health Risk Assessments of Environmental Chemicals

    Date and Time:Friday, October 31, 2014 1:00 PM, Eastern Daylight Time (New York, GMT-04:00) Event number: 732 598 837

    Event Type: Other Scientific Events
    Organization: SELECTBIO
    Event Title: Food Analysis Congress
    Event Date or Start Date: 10/29/2014
    End Date: 10/30/2014
    Country: SPAIN
    State or Region: Barcelona
    Meeting Web Site: goo.gl/cvdOuJ
    Additional Meeting Information: SELECTBIO’s inaugural Food Analysis Congress aims to present the latest developments in food analysis technologies, in response to the increasing demand for rapid and efficient food safety and quality testing.

    Focus will be given to advances in both the analysis of natural food allergens and toxins, as well as contaminants introduced through processing and packaging. Points for discussion will also include the ongoing issue of food traceability and efforts to reduce food fraud. Attending this event will provide you with excellent opportunities for networking with like minded peers, helping you to find solutions and build collaborations.

    Event Type: Other Scientific Events
    Organization: SMI Group Ltd
    Event Title: Point of Care
    Event Date or Start Date: 10/27/2014
    End Date: 10/28/2014
    Country: UNITED KINGDOM
    State or Region: London
    Meeting Web Site: http://atnd.it/12771-2
    Additional Meeting Information: The global market for Point of Care diagnostics is set to sharply increase by 2018 and Europe’s market is becoming increasingly competitive due to its low barriers of entry.

    Based on this information SMi is proud to present its 11th annual Point of Care conference which will focus on the implementation, including interoperability of technology and data management that is critical to the success of Point of Care Testing (PoCT). Topics that will be examined include: enhancing quality in PoCT; trends in microfluidics for health; industry standards; and how to protect intellectual property of PoCT devices.

    Event Type: Other Scientific Events
    Organization: Endocrine Society
    Event Title: PPTOX IV: Environmental Stressors in Disease and Implications for Human Health
    Event Date or Start Date: 10/26/2014
    End Date: 10/29/2014
    Country: UNITED STATES
    State or Region: MA
    Meeting Web Site: www.endocrine.org/pptox
    Additional Meeting Information: View full program details and register for the fourth international summit of Prenatal Programming and Toxicity (PPTOX) – a conference series dedicated to cutting-edge discussion of environmental hazards during early life and long-term consequences. PPTOX IV hosts the world’s leading experts in endocrinology, toxicology, and environmental health to provide interdisciplinary discussions on the current landscape, future directions, and global implications for this burgeoning field in research, medicine, and regulation. Abstracts are welcome for oral or poster presentation. In-training and early career members are encouraged to apply for an abstract-based travel award.

    Key Dates
    • Abstract Submission Deadline - Sept 2
    • Advanced Registration - Sept 10
    • Group Rate Housing Deadline - Oct 6





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