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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: 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).

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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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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


Event Type: Regional Chapter
Organization: Michigan Regional Chapter
Event Title: Michigan RC Fall Meeting
Event Date or Start Date: 10/24/2014
End Date: 10/24/2014
Country: UNITED STATES
State or Region: MI
Meeting Web Site: www.toxicology.org/isot/rc/misot/meetings.asp
Additional Meeting Information:

Event Type: Webinars
Organization: The National Research Council
Event Title: A Framework to Guide Selection of Chemical Alternatives
Event Date or Start Date: 10/24/2014
End Date: 10/24/2014
Country: UNITED STATES
State or Region: DC
Meeting Web Site: dels.nas.edu/Report/Framework-Guide-Selection/18872
Additional Meeting Information: Concerns about the health and environmental impacts associated with some chemical products and processes have motivated a growing number of national, state, and local governments, manufacturers, and retailers to develop assessments and approaches for finding safer chemical substitutes. These existing assessment frameworks reflect a range of different priorities, whether the focus is on protecting workers, the environment, the end users of products, or other interests. The National Research Council report A Framework to Guide Selection of Chemical Alternatives builds on those frameworks to develop a more universally-applicable decision framework for evaluating potentially safer chemical alternatives.

This webinar will feature a presentation from Dr. David Dorman of North Carolina State University, the Chair of the report’s authoring committee, followed by a Q&A session with Dr. Dorman and other committee members.

Event Type: Regional Chapter
Organization: South Central Regional Chapter
Event Title: South Central RC Fall Meeting
Event Date or Start Date: 10/23/2014
End Date: 10/24/2014
Country: UNITED STATES
State or Region: MS
Meeting Web Site: www.toxicology.org/isot/rc/southCentral/events.asp
Additional Meeting Information: The deadline for abstract submission is Tuesday, September 23, 2014.

Event Type: Regional Chapter
Organization: Southeastern Regional Chapter
Event Title: Southeastern RC Fall Meeting
Event Date or Start Date: 10/23/2014
End Date: 10/24/2014
Country: UNITED STATES
State or Region: GA
Meeting Web Site: www.toxicology.org/isot/rc/sesot/events.asp
Additional Meeting Information: The deadline for abstract submission is October 1, 2014.

Event Type: Other Scientific Events
Organization: GTCbio
Event Title: Protein Discovery Summit 2014
Event Date or Start Date: 10/23/2014
End Date: 10/24/2014
Country: UNITED STATES
State or Region: MA
Meeting Web Site: www.gtcbio.com/conferences/pd-overview
Additional Meeting Information: This summit covers major hot topics in the field that split into four parallel conferences.

Areas of discussion include novel techniques, new algorithms and databases for PPIs, and potential druggable sites for disrupting protein-protein interactions. Data and case studies on key topics such as antibody drug conjugates, bispecific antibodies and overcoming the blood-brain barrier will also be discussed. This unique multi conference summit also covers the expression of difficult proteins, new methods of purification, extended characterization of production cell lines, the production of reagents for biologic programs, and analytical tools and computational methods. Don't miss Important insights on how to overcome the many hurdles and answer exciting key questions for the successful development of new drugs and targeting kinase signaling. Come hear experts share their positive and negative experiences on how predictive preclinical models are with clinical efficacy and toxicology!

The Protein Discovery Summit is the ideal venue to network with your fellow researchers, providing access to over 125 presentations from leading industrial and academic experts and will feature research findings, case studies and technology advancements.

Event Type: Other Scientific Events
Organization: GTCbio
Event Title: Protein-Protein Interaction
Event Date or Start Date: 10/23/2014
End Date: 10/24/2014
Country: UNITED STATES
State or Region: MA
Meeting Web Site: www.gtcbio.com/conferences/ppi-overview
Additional Meeting Information: The relatively new field of protein-protein interaction (PPI) is experiencing fantastic growth in the field of drug discovery. The key concepts of PPI are to understand how proteins interact, to understand why inhibiting them is beneficial, and how to identify molecules that block the interactions as treatment strategies.

This upcoming meeting will have sessions that cover novel techniques, new algorithms and databases for PPIs, and potential druggable sites for disrupting protein-protein interactions. Attendees will gain an enhanced understanding of the molecular basis of peptide and protein aggregation and insights into the design of inhibitors of peptide and protein aggregation. Some focused topics we will discuss is how inhibiting PPIs can be a promising therapeutic target, PPI interactions within the TNF family, the first small-molecule inhibitors for the CD40–CD40L, and much more including the fundamental aspects of protein-protein interactions.

Event Type: Other Scientific Events
Organization: GTCbio
Event Title: Protein Expression, Purification, and Characterization
Event Date or Start Date: 10/23/2014
End Date: 10/24/2014
Country: UNITED STATES
State or Region: MA
Meeting Web Site: www.gtcbio.com/conferences/protein-expression-purification-characterization-2014-overview
Additional Meeting Information: This conference strives to connect industry and academic researchers in the protein therapeutics field to facilitate discussion on the current state of the industry and discuss opportunities and challenges involved in therapeutic development.

Representatives from big pharma, academic institutions and government research labs will present data and case studies on key topics such as antibody drug conjugates, bispecific antibodies and overcoming the blood-brain barrier. Attend to learn and network with key opinion leaders in a highly interactive and intimate environment.

Event Type: Other Scientific Events
Organization: GTCbio
Event Title: Antibody and Protein Therapeutics
Event Date or Start Date: 10/23/2014
End Date: 10/24/2014
Country: UNITED STATES
State or Region: MA
Meeting Web Site: www.gtcbio.com/conferences/antibody-protein-therapeutics-overview
Additional Meeting Information: GTC welcome you to the Antibody and Protein Therapeutics Conference being held on October 23-24, 2014 in Boston, Massachusetts.

This conference strives to connect industry and academic researchers in the protein therapeutics field to facilitate discussion on the current state of the industry and discuss opportunities and challenges involved in therapeutic development.

Representatives from big pharma, academic institutions and government research labs will present data and case studies on key topics such as antibody drug conjugates, bispecific antibodies and overcoming the blood-brain barrier. Attend to learn and network with key opinion leaders in a highly interactive and intimate environment.

Event Type: Other Scientific Events
Organization: DIA Europe
Event Title: 4th African Regulatory Conference
Event Date or Start Date: 10/22/2014
End Date: 10/23/2014
Country: SENEGAL
State or Region:
Meeting Web Site: atnd.it/11023-0
Additional Meeting Information: This is the 4th DIA African Regulatory Conference (ARC) co-organised by the Drug Information Association (DIA) and the IFPMA’s African Regulatory Network (ARN). IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) represents the researchbased pharmaceutical companies and associations across the globe. The research-based pharmaceutical industry’s 1.3 million employees strive to develop and provide innovative medicines, biological products, and vaccines that improve patients’ lives worldwide.

Event Type: Other Scientific Events
Organization: Health Network Communications
Event Title: Evidence USA 2014
Event Date or Start Date: 10/22/2014
End Date: 10/23/2014
Country: UNITED STATES
State or Region:
Meeting Web Site: atnd.it/14445-4
Additional Meeting Information: Evidence USA is the America's largest and most holistic event on the use of real world outcomes for pharmaceutical products: an exhibition, a series of seminars, and a multi track strategic conference.

Top reasons to attend:
  • Understand the impact of real world evidence on the future healthcare environment
  • Design and execute successful real world trials Get big value from your big data: collection, interpretation and communication strategies
  • Understand stakeholder demands from real world evidence
  • Revolutionize patient access to valuable medicines
  • Demonstrate compelling value propositions in the US and globally
  • Review the enabling technologies in evidence generation
  • Use observational research to demonstrate value
Last year''s event saw over 200 attendees, 40 industry speakers, and 20+ hours of dedicated networking opportunities.

Event Type: Regional Chapter
Organization: Northern California Regional Chapter
Event Title: Northern California RC Fall Meeting
Event Date or Start Date: 10/21/2014
End Date: 10/21/2014
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/isot/rc/NorCal/events.asp
Additional Meeting Information:

Event Type: Other Scientific Events
Organization: SMI Group Ltd
Event Title: Orphan Drugs and Rare Diseases
Event Date or Start Date: 10/20/2014
End Date: 10/21/2014
Country: UNITED KINGDOM
State or Region:
Meeting Web Site: atnd.it/11868-0
Additional Meeting Information: As of January 2014, the EMA lifted the restriction on providing fee reductions to large companies developing new orphan drugs and the Early Access to Medicines Scheme was introduced. Key implementation of this will be a factor into further commercialization and developments.

Based on this information SMi Group is proud to announce it will be hosting the 3rd annual conference on Orphan Drugs and Rare Diseases and bringing together leading experts and companies such as Novabiotics, Pfizer, AstraZeneca, GMP Orphan SAS, Genethon and M&C Saatchi and many more to discuss the latest developments in the market.

Event Type: Other Scientific Events
Organization: Safety Pharmacology Society
Event Title: 14th Annual Safety Pharmacology Society Meeting
Event Date or Start Date: 10/19/2014
End Date: 10/22/2014
Country: UNITED STATES
State or Region: DC
Meeting Web Site: www.safetypharmacology.org/AM2014/index.asp
Additional Meeting Information: The Safety Pharmacology Society (SPS) 14th Annual Meeting will be held October 19–22, 2014, in Washington, DC and will provide a dynamic forum for sharing the latest in safety pharmacology. The scientific program will offer in-depth discussions of relevant topics to keep you “in the know.” This meeting will feature a diverse range of scientific sessions organized into two tracks, covering issues such as, Cardiovascular, Central Nervous System, Non Cardiac Ion Channels, Respiratory, Regulatory, New Assays, Peripheral Neuropathy, and an all day Plenary on Wednesday covering the Updates and Perspectives on Comprehensive In Vitro Proarrhythmia Assay (CIPA). The meeting also will offer a full day of Continuing Education courses on October 19, both on an introductory level as well as advanced courses for the expert, and the Diplomate in Safety Pharmacology (DSP) Certification exam will be held the day before the meeting on October 18. For preliminary meeting information, please visit the SPS Annual Meeting website.

Event Type: Other Scientific Events
Organization: American Academy of Clinical Toxicology and the American Association of Poison Control Centers
Event Title: North American Congress of Clinical Toxicology
Event Date or Start Date: 10/17/2014
End Date: 10/21/2014
Country: UNITED STATES
State or Region: LA
Meeting Web Site: www.clintox.org
Additional Meeting Information: The North American Congress of Clinical Toxicology (NACCT) is the world’s largest clinical toxicology meeting, bringing together scientists and clinicians from across the globe. The content provides ongoing education for healthcare professionals managing poisoned patients and health educators working in clinical toxicology with continuing education credit available for physicians, pharmacists, nurses and educators. 2014 NACCT will be held in New Orleans, Louisiana and will offer two days of pre-conference workshops prior to the meeting, and three full days of platform, panel and poster sessions along with hands-on training and clinical symposia.

Event Type: Regional Chapter
Organization: Mid-Atlantic Regional Chapter
Event Title: Mid-Atlantic RC Fall Meeting
Event Date or Start Date: 10/16/2014
End Date: 10/16/2014
Country: UNITED STATES
State or Region: NJ
Meeting Web Site: www.toxicology.org/isot/rc/midatlantic/Fall2014Meet.asp
Additional Meeting Information: “Exploring the Human Microbiome: Roles in Disease, Toxicology, and Drug Development”

Event Type: Regional Chapter
Organization: Southern California Regional Chapter
Event Title: Southern California RC Fall Meeting
Event Date or Start Date: 10/16/2014
End Date: 10/16/2014
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.toxicology.org/isot/rc/SouthernCal/index.asp
Additional Meeting Information: “Translational Safety in Drug Development—Innovations and Challenges”

This year’s event is a joint meeting with the Critical Path Institute (C-Path), a public-private partnership with the FDA created under the auspices of the FDA’s C-Path program in 2005. The program will cover an exciting agenda on the contemporary topic of translational safety in drug development.

Event Type: Regional Chapter
Organization: Central States Regional Chapter
Event Title: Central States RC Fall Meeting
Event Date or Start Date: 10/16/2014
End Date: 10/17/2014
Country: UNITED STATES
State or Region: MO
Meeting Web Site: www.toxicology.org/isot/rc/centralstates/index.asp
Additional Meeting Information: Selecting Model Systems for Toxicology Studies – “All models are wrong. Some models are useful.” Thursday, October 16—MRIGlobal 425 Volker Boulevard, Kansas City, MO 64110-2299

Friday, October 17—Hampton Inn & Suites Kansas City—Country Club Plaza 4600 Summit Kansas City, MO 64112

Event Type: Other Scientific Events
Organization: DIA Europe
Event Title: How To Prepare For Your Meeting With Health Authorities
Event Date or Start Date: 10/14/2014
End Date: 10/15/2014
Country: FRANCE
State or Region: Paris
Meeting Web Site: atnd.it/12259-0
Additional Meeting Information: Working in the pharmaceutical industry, you will sooner or later be faced with health authority meetings, be it during product development, during the application for a marketing authorisation or later in the lifecycle of your medicinal products to discuss pharmacovigilance matters.

This course covers Health Authority (HA) meetings (and other interactions) in the EU and the US. You will learn how to best handle the preparation, and the meeting with the HA itself through role playing and analysis of case studies.

Event Type: Other Scientific Events
Organization: SMI Group
Event Title: 20th annual European Pharmaceutical Pricing and Reimbursement
Event Date or Start Date: 10/13/2014
End Date: 10/14/2014
Country: UNITED KINGDOM
State or Region: London
Meeting Web Site: atnd.it/12169-0
Additional Meeting Information: Market access remains one of the most significant current and future challenges for the industry. Spiraling drug development costs exert pressure to ensure successful and effective planning of your access strategies. With up to $5 billion in R&D costs for every successful drug launched, winning strategies are critical . Understanding the strengths and shortcomings in your people, processes and evidence are going to be the keys to your success. Planning around these key factors will enable increased market share for your organization.

This year's conference will be held on October 13-14. Now in its 20th year, this event has been one of the oldest market leaders in the pharmaceutical industries calendar for some time. Our expert speaking faculty; made up from key industry personnel from big pharma, biotech and academia will thoroughly explain and offer advice on P&R and market access. The 2014 agenda will focus on case studies as applied to different countries and environments in terms of market access.

Event Type: SOT Sponsored Non-SOT Meeting
Organization: International Society of Exposure Science
Event Title: 24th Annual Meeting of the International Society of Exposure Science
Event Date or Start Date: 10/12/2014
End Date: 10/16/2014
Country: UNITED STATES
State or Region: OH
Meeting Web Site: www.ises2014.org/index.html
Additional Meeting Information: ISES is launching the inclusion of courses on a regular basis at our annual conference. These courses will be eligible for Continuing Education credits for many professional societies. Each year, a selection of topical courses will be offered on Sunday and taught by renowned experts. Please visit the meeting website for more information on the different courses. The theme is Exposure Science Integration to Protect Ecological Systems, Human Well-Being, and Occupational Health. The program will foster the integration of exposure science as applied to community, occupational, and ecological health as recommended by the NRC Exposure Science in the 21st Century. We plan to highlight the value that exposure science has brought to the protection of health and the environment and its growing importance in the face of such global threats of population pressure, climate change, nitrogen cycling, water and energy availability.

Event Type: Regional Chapter
Organization: North Carolina Regional Chapter
Event Title: North Carolina RC Fall Meeting
Event Date or Start Date: 10/9/2014
End Date: 10/9/2014
Country: UNITED STATES
State or Region: NC
Meeting Web Site: www.toxicology.org/isot/rc/nc/meetings.asp
Additional Meeting Information: Hot Topics in Toxicology Fracking, Coal Fly Ash, E Cigarettes

Event Type: Other Scientific Events
Organization: GlobalCompliancePanel
Event Title: The DHF, Technical File and Design Dossier—Similarities, Differences and the Future
Event Date or Start Date: 10/9/2014
End Date: 10/10/2014
Country: UNITED STATES
State or Region: NV
Meeting Web Site: bit.ly/1lE4ydK
Additional Meeting Information: This seminar / workshop will examine the existing and proposed requirements for the U.S. FDA''s DHF -- including its derivative documents, the DMR and DHR. It will consider the European Union''s MDD TF/DD requirements, and evaluate the documents'' differing purposes / goals, their similarities, as well as the two different device classification schemes.

Event Type: Annual Meeting
Organization: GTCbio
Event Title: 9th Cell Based Assay & Screening Technologies Conference
Event Date or Start Date: 10/7/2014
End Date: 10/8/2014
Country: IRELAND
State or Region: Dublin
Meeting Web Site: www.gtcbio.com/conferences/9th-cell-based-assays-screening-technology-2014-europe-overview?utm_source=9%20cbas&utm_medium=website&utm_content=cbas_overview&utm_campaign=listing
Additional Meeting Information: Over the past years, the field of assay technologies, laboratory automation, and informatics has taken great leaps forward. Present demands from the drug discovery process have propelled a shift in focus from high throughput screening to high content analysis, and there is a greater push for using iPS stem cells combined with 3D cell culture technologies for more physiologically relevant screen models. These developments have raised questions such as, what is the best model for screening for cell based assays? What is the payback of physiologically relevant systems?

This meeting will provide a forum for industry leaders from major pharmaceutical companies and cutting-edge biotech companies, top researchers from academia, and software and technology providers to present innovative and relevant applications of current assay and screening technologies to continually improve efficacy and meaningful data output. Join us as we discuss recent advances and developments in 3D cell cultures, phenotypic screening, breakthrough genome-editing technologies such as CRISPRs, and other predictive tools that can improve clinical outcomes in drug discovery and development.

Event Type: Other Scientific Events
Organization: GTCbio
Event Title: 7th Imaging in Drug Discovery Conference
Event Date or Start Date: 10/7/2014
End Date: 10/8/2014
Country: IRELAND
State or Region: Dublin
Meeting Web Site: www.gtcbio.com/conferences/imaging-drug-discovery-2014-europe-overview?utm_source=Imaging&utm_medium=website&utm_content=Imaging_overview&utm_campaign=listing
Additional Meeting Information: We are excited to announce GTCbio’s 7th Imaging in Drug Discovery Conference, to be held October 7-8, 2014 in Dublin, Ireland. Imaging has long been a powerful tool in the drug discovery process, and we invite you to join us as we continue to discuss how imaging technologies can be better translated from preclinical to clinical studies.

This meeting seeks to provide a forum for researchers from both industry and academia to share about the latest advances in imaging applications in drug safety and metabolism, cancer immunotherapy, neurodegenerative disorders, and much more. In addition, technology and software providers will have the opportunity to share their solutions.

Event Type: Other Scientific Events
Organization: GTCbio
Event Title: Drug Discovery Week Europe
Event Date or Start Date: 10/7/2014
End Date: 10/10/2014
Country: IRELAND
State or Region:
Meeting Web Site: www.gtcbio.com/conferences/drug-discovery-week-europe-overview?utm_source=postconferences&utm_medium=ddweekeuro&utm_campaign=overview
Additional Meeting Information: We are pleased to invite you to join us at GTCbio’s Drug Discovery Week Europe (DDWE), in Dublin, Ireland. This week will feature two summits, each comprised of two parallel conferences, that will take place over the course of the four days:

Technologies in Drug Discovery Summit
This summit will provide a multidisciplinary forum for researchers to learn about the latest tools, technologies, and software that will better predict early-stage and help facilitate drug discovery. Topics such as phenotypic screening, 3D cell models, high-content imaging, and imaging in neurodegenerative disorders. Biomarker Summit
Leaders in the field will gather to address the latest developments in the biomarker arena from discovery to translation to commercialization. Presentations will span multiple disciplines and cover topics such as discovery and validation strategies, challenges of clinical translation, novel technologies such as next-generation sequencing, regulatory issues, and companion diagnostics.

Event Type: Other Scientific Events
Organization: UBM Live
Event Title: CPhI Worldwide
Event Date or Start Date: 10/6/2014
End Date: 10/9/2014
Country: FRANCE
State or Region: Paris
Meeting Web Site: atnd.it/15051-0
Additional Meeting Information: CPhI Worldwide: the number one Pharma sourcing event in the world. CPhI Worldwide amazingly hosts 2,500 exhibitors and welcomes around 35,000 attendees from 140 countries. Meet face-to-face with international pharmaceutical decision makers, stay informed about the latest industry trends and remain one step ahead of a constantly changing pharmaceutical market.

Event Type: Other Scientific Events
Organization: UBM Live
Event Title: CPhI Pre-Connect 2014
Event Date or Start Date: 10/6/2014
End Date: 10/6/2014
Country: FRANCE
State or Region: Paris
Meeting Web Site: atnd.it/15653-0
Additional Meeting Information:

Comprised of modules on the latest and hottest topics in the industry, the Pre-Connect Congress offers you the exclusive opportunity to meet senior executives and influential speakers from across the pharma industry to gain a head start on your networking in an informative and interactive environment. Delegates interested in attending more than one module will be able to attend an entire day of inspiring talks.


Event Type: Other Scientific Events
Organization: IQPC
Event Title: Big Data in Pharma
Event Date or Start Date: 9/30/2014
End Date: 10/1/2014
Country: BELGIUM
State or Region: Brussels
Meeting Web Site: http://www.bigdatainpharma.com/default.aspx
Additional Meeting Information:

The volume of data on pharma/healthcare is growing at an exponential rate—much faster than the industry can keep up with, which is great in one respect. However, pharma companies are under pressure to manage all this data effectively. Data without meaning is useless—turning data into value and innovation.

Data needs to be managed, extracted, analyzed and re-used if companies want to stay ahead and develop innovative products.


Event Type: Other Scientific Events
Organization: US Environmental Protection Agency
Event Title: US EPA’s Chemical Safety Research: Second ToxCast Data Summit
Event Date or Start Date: 9/29/2014
End Date: 9/30/2014
Country: UNITED STATES
State or Region: NC
Meeting Web Site: sites.google.com/site/toxcastdatasummit/
Additional Meeting Information: Bring together the user community (industry, non-governmental organizations, academia, governmental agencies, and more) to present their ideas for using massive amounts of new chemical data, and begin a dialogue about how to implement these ideas to inform chemical policy and regulatory decisions.

Event Type: Other Scientific Events
Organization: GlobalCompliancePanel
Event Title: Effective Complaint Handling, Medical Device Reporting and Recalls and Avoiding Costly Errors
Event Date or Start Date: 9/29/2014
End Date: 9/30/2014
Country: SWITZERLAND
State or Region: Zurich
Meeting Web Site: bit.ly/Y7J4ef
Additional Meeting Information: An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analysed, and corrective action shall be taken.

Event Type: Other Scientific Events
Organization: International Conference on Neuroprotective Agents
Event Title: Twelfth International Conference on Neuroprotective Agents
Event Date or Start Date: 9/28/2014
End Date: 10/1/2014
Country: UNITED STATES
State or Region: VA
Meeting Web Site: www.neuroprotective.org
Additional Meeting Information: The International Conference on Neuroprotective Agents has been relatively unique in its role of bringing together clinical and basic science researchers from various countries and various disciplines related to neuroprotection in an intellectually stimulating and socially relaxing environment to discuss strategies to protect the nervous system. The multidisciplinary background of the participants and the meeting’s structure (all sessions, including the poster session, are attended by all participants; meals and social events are also group functions) fosters in-depth, real-time discussion and debate. The ICNA brings together researchers involved in (1) conditions toxic to the nervous system (e.g. heat, diabetes, drugs (therapeutic and illicit), alcohol, anesthetic agents, and stroke); (2) neurodegenerative processes ‘toxic’ to the nervous system (e.g. Parkinson’s disease, Alzheimer’s disease); (3) molecular and nanotechnology techniques for understanding nervous system disorders, nervous system repair mechanisms, and neurotoxicity issues; and (4) the fields of personalized, predictive, and preventive medicine as they relate to neuroprotection.

Event Type: Regional Chapter
Organization: Northeast Regional Chapter
Event Title: Northeast RC Fall Meeting
Event Date or Start Date: 9/26/2014
End Date: 9/26/2014
Country: UNITED STATES
State or Region: CT
Meeting Web Site: www.toxicology.org/isot/rc/nesot/events.asp
Additional Meeting Information:

Event Type: Regional Chapter
Organization: Ohio Valley Regional Chapter
Event Title: Ohio Valley RC Fall Meeting
Event Date or Start Date: 9/26/2014
End Date: 9/26/2014
Country: UNITED STATES
State or Region: OH
Meeting Web Site: www.toxicology.org/isot/rc/ovsot/annmeets.asp
Additional Meeting Information: This year’s meeting will feature a keynote lecture by Dr. Vishal Vaidya entitled, “Translational Toxicology in the Twenty-First Century” as well as student and postdoc platform and poster presentations, Lunch with an Expert, and exciting information about our K–12 activities.

Event Type: Webinars
Organization: Association of Scientists of Indian Origin Special Interest Group
Event Title: New Frontiers in Chemical Carcinogenesis
Event Date or Start Date: 9/26/2014
End Date: 9/26/2014
Country: UNITED STATES
State or Region:
Meeting Web Site: aim-hq.webex.com/mw0401l/mywebex/default.do?nomenu=true&siteurl=aim-hq&service=6&rnd=0.65674894448716&main_url=https%3A%2F%2Faim-hq.webex.com%2Fec0701l%2Feventcenter%2Fevent%2FeventAction.do%3FtheAction%3Ddetail%26confViewID%3D1818298453%26%26EMK%3D4832534b0000000159387f07c55278afd0167fe2021dfc7ab6b20c245fd08f440a6a1715362db70f%26%26%26siteurl%3Daim-hq
Additional Meeting Information: Friday, September 26, 2014 12:00 Noon Eastern Daylight Time (New York, GMT-04:00)

ASIO initiated Tox-Webinar series last year with the goal to educate students and fellow scientists on the latest developments of toxicological sciences. Based on the valuable inputs from the members of Society of Toxicology, ASIO is planning to host a topic on chemical carcinogenesis. The speaker is Dr. Udayan Apte from University of Kansas Medical Center, who is an expert in hepatotoxicology and has extensive experience working on mechanisms of liver regeneration, hepatic stem cells and mechanisms of chemical carcinogenesis.

Webinar Topic: New Frontiers in Chemical Carcinogenesis

Speaker:
Dr. Udayan Apte, PhD Associate Professor, Department of Pharmacology, Toxicology and Therapeutics, University of Kansas Medical Center Kansas City, Kansas

Event Type: Other Scientific Events
Organization: GlobalCompliancePanel
Event Title: Effective Complaint Handling, Medical Device Reporting and Recalls and Avoiding Costly Errors
Event Date or Start Date: 9/25/2014
End Date: 9/26/2014
Country: AUSTRALIA
State or Region: Sydney
Meeting Web Site: bit.ly/1yyH8Xl
Additional Meeting Information: The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labelling, packaging or distribution. The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. Trending is the only way a company can stay on top of emerging quality issues and address those that are most pressing.

Event Type: Other Scientific Events
Organization: DIA Europe
Event Title: Workshop on Biorelevant In Vitro Performance Testing
Event Date or Start Date: 9/24/2014
End Date: 9/25/2014
Country: NETHERLANDS
State or Region:
Meeting Web Site: atnd.it/12180-0
Additional Meeting Information: This workshop will discuss data on the lumenal environment, its simulation, biorelevant in vitro performance testing methodologies that can be applied during product development, as well as relevant in silico modelling methodologies. Case studies from industry will describe the application of biorelevant testing methodologies for formulation design, selection and development vs. currently applied procedures in quality control testing. In addition, presentations from the FDA and National Competent Authorities will cover the use of biorelevant testing in the evaluation of a drug’s performance.

Visit the website for more information.

Event Type: Webinars
Organization: Medical Device and Combination Products Specialty Section
Event Title: MDCPSS Fall Webinar: Quantitative Risk Assessment of the Genotoxicity and Tumorigenicity of CoCr-Containing Hip Implants
Event Date or Start Date: 9/24/2014
End Date: 9/24/2014
Country: UNITED STATES
State or Region:
Meeting Web Site: aim-hq.webex.com/mw0401l/mywebex/default.do?nomenu=true&siteurl=aim-hq&service=6&rnd=0.7758473952307141&main_url=https%3A%2F%2Faim-hq.webex.com%2Fec0701l%2Feventcenter%2Fevent%2FeventAction.do%3FtheAction%3Ddetail%26confViewID%3D1820379497%26%26EMK%3D4832534b00000001ae42172a60f23e183a1d4480cfb4d538e9eb42cb571433ae752c0139ec7b816d%26%26%26siteurl%3Daim-hq
Additional Meeting Information: Cobalt-chromium (CoCr) alloys have long been used in metal-containing hip implants because of their biocompatibility. Like all implant materials, CoCr alloys undergo some degree of wear and corrosion in vivo, and as a result implant patients experience blood and tissue Co and Cr(III) concentrations that are higher than background levels associated with dietary intake. Although to date epidemiology studies do not indicate an increased incidence of cancer in patients with hip implants, questions continue to be raised about the potential cancer risk posed by CoCr-containing implants. To address these concerns, the scientific literature investigating the genotoxic and tumorigenic effects of Co particles and ions, Cr particles and ions, CoCr alloy particles, as well as CoCr alloy implants was gathered, and NOAEL/LOAEL values were compared with body burdens of Co/Cr particles and ions that were calculated to exist in systemic tissues of hip implant patients under normal and excessive wear conditions. This presentation will illustrate the quantitative methods that were used to evaluate the weight-of-evidence regarding a causative relationship between CoCr-containing hip implants and increased cancer risk to determine whether the existing toxicology data support epidemiological findings. Speaker: Whitney V. Christian, Ph.D., of CARDNO CHEMRISK, Pittsburgh, PA

Event Type: Other Scientific Events
Organization: Terrapinn Briefings
Event Title: Big Data in Pharma
Event Date or Start Date: 9/23/2014
End Date: 9/23/2014
Country: UNITED KINGDOM
State or Region: London
Meeting Web Site: atnd.it/15015-0
Additional Meeting Information: The volume of data is exploding, and that is challenging drug makers'' ability to transform big data into additional revenue. But companies who can exploit big data and analytics will have the potential to improve their productivity and efficiency, especially in the discovery, research and development of new products, experts say.

McKinsey has predicted big data could reduce research and development costs for pharmaceutical makers by $40 billion to $70 billion. They anticipate that data will form the cornerstone of future value-based assessment and also be used for gaining market access, and enhance competitiveness.

Event Type: Other Scientific Events
Organization: DIA Europe
Event Title: Clinical Trials Workshop I Translating the New Clinical Trials Regulation into Practice
Event Date or Start Date: 9/23/2014
End Date: 9/24/2014
Country: UNITED KINGDOM
State or Region: London
Meeting Web Site: atnd.it/8826-0
Additional Meeting Information:

This 2-day workshop will provide a forum for information exchange and discussion on conceptual and practical questions through lectures, panel discussions, and interactive break-out sessions.

Day 1 will focus on the new provisions for submission, assessment and decision-making of clinical trial applications, and the management and monitoring of trials. Day 2 will focus on the new transparency provisions for clinical trials.


Event Type: Regional Chapter
Organization: National Capital Area Regional Chapter
Event Title: National Capital Area Chapter Fall Webinar
Event Date or Start Date: 9/19/2014
End Date: 9/19/2014
Country: US
State or Region:
Meeting Web Site: www.toxicology.org/isot/rc/ncac/events.asp
Additional Meeting Information: NCAC-SOT Fall Webinar: A Walk Through the National Academies Review of US EPA’s IRIS Process: Implications for Hazard Assessment Friday, September 19, 9:30 AM–12:00 Noon EDT

Event Type: Annual Meeting
Organization: GTCBio
Event Title: 7th CNS Partnering & Deal-Making Conference (September 18-19, San Francisco, CA)
Event Date or Start Date: 9/18/2014
End Date: 9/19/2014
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.gtcbio.com/conference/cns-partnering-and-deal-making-overview?utm_source=cnspdl&utm_medium=website&utm_content=csnpdloverview&utm_campaign=cnspdl
Additional Meeting Information: We are excited to announce the 7th CNS Partnering & Deal-Making Conference, to be held in San Francisco, CA. Over the past years, this partnering and business development conference has given global biotechnology and pharmaceutical companies an opportunity to network with high-level executives from top pharma and various biotech/pharmaceutical companies, as well as explore potential collaborations, and learn about relevant CNS disease issues that will affect the industry.

With the unmet need for CNS treatments growing, it is time to reevaluate how we partner with other stakeholders in the field to accelerate research. We will discuss research consortia, collaborations between academic centers and industry, and the growing role of patient groups and foundations. This meeting creates a space for leaders in the field to gather and invest in partnerships that will accelerate research and move the field forward.

Contact Info: Kristen Starkey
635 W. Foothill Blvd. Monrovia, CA 91016
Tel: 626.256.6405
Fax: 626.466.4433

Event Type: Other Scientific Events
Organization: GTCbio
Event Title: 8th Neurodegenerative Conditions Research & Development Conference
Event Date or Start Date: 9/18/2014
End Date: 9/19/2014
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.gtcbio.com/conference/neurodegenerative-conditions-research-and-development-overview?utm_source=ndc8&utm_medium=website&utm_content=overview&utm_campaign=ndc
Additional Meeting Information: It is our pleasure to announce the 8th Neurodegenerative Conditions Research & Development Conference, to be held on September 18-19, 2014 in San Francisco, to discuss the latest scientific discovery in the neuroscience field.

We invite you to join us to discuss much more than just research itself, but the partnerships and alliances that are being and need to be formed in order to continue pushing research forward into the future. What are the best models of private/public partnerships? How are patient advocacy groups changing the way we think about funding and research? How will we work with government groups? This meeting seeks to provide a forum to dialogue about such questions and begin formulating answers at this critical time in the field.

Event Type: Regional Chapter
Organization: Pacific Northwest Regional Chapter
Event Title: Pacific Northwest RC Fall Meeting
Event Date or Start Date: 9/18/2014
End Date: 9/19/2014
Country: UNITED STATES
State or Region: WA
Meeting Web Site: www.toxicology.org/isot/rc/panwat/annmeets.asp
Additional Meeting Information: We are soliciting abstracts for sessions on Friday, September 19. We will also host a mentoring activity on Thursday evening.

Event Type: Webinars
Organization: Mci Group
Event Title: 21st European Paediatric Rheumatology Congress
Event Date or Start Date: 9/17/2014
End Date: 9/21/2014
Country: SERBIA
State or Region: Serbia
Meeting Web Site: atnd.it/6262-0
Additional Meeting Information:

Leading experts and scientists from all over the world will join us in Belgrade and the Scientific Committee compiled an attractive program to bring you all the latest clinical developments and cutting-edge translational science in the rapidly developing field of pediatric rheumatology.

The scope of PReS 2014 covers genetics, immune-pathogenesis, recent clinical innovations and treatment advances of rheumatic diseases in children with special focus on JIA (juvenile idiopathic arthritis).

We will be pleased if you join us in Belgrade and hope you enjoy an exciting combination of science, professional exchange and meeting with old and new friends in a pleasant atmosphere.


Event Type: SOT Sponsored Non-SOT Meeting
Organization: American College of Toxicology
Event Title: Practical Application of Toxicology in Drug Development
Event Date or Start Date: 9/15/2014
End Date: 9/19/2014
Country: UNITED KINGDOM
State or Region: Edinburgh
Meeting Web Site: www.actox.org/meetCourses/patdd.asp
Additional Meeting Information: This course, taught by distinguished experts, is designed to provide a basic training in toxicology. Participants will obtain an overall understanding of the principles of nonclinical safety evaluation with emphasis on the practical application of these principles and interpretation of nonclinical safety data. The course will include discussion of regulatory case studies and a workshop. This toxicology course is intended to benefit individuals working with small and large molecules from biotechnology and pharmaceutical companies, along with those from Contract Research Organizations and regulatory agencies who are interested in toxicology. Regulatory toxicology in drug development will be emphasized, particularly from the European perspective.

Event Type: Other Scientific Events
Organization: SMI Group
Event Title: Cancer Vaccines
Event Date or Start Date: 9/15/2014
End Date: 9/16/2014
Country: UNITED KINGDOM
State or Region: London
Meeting Web Site: atnd.it/10967-0
Additional Meeting Information: This year's program will feature a mix of case study led presentations, networking opportunities, an interactive workshop and keynote addresses that have been tailored for an audience of professionals working in the cancer vaccine market from drug design through to clinical trials and treatment.

To register or download a brochure www.cancer-vaccinesevent.com.

Event Type: SOT Sponsored Non-SOT Meeting
Organization: Environmental Mutagenesis and Genomics Society
Event Title: Environmental Mutagenesis and Genomics Society 45th Annual Meeting
Event Date or Start Date: 9/13/2014
End Date: 9/17/2014
Country: UNITED STATES
State or Region: FL
Meeting Web Site: www.emgs-us.org/am2014/index.asp
Additional Meeting Information: The 45th Annual Meeting of the Environmental Mutagenesis and Genomics Society (EMGS), will be held September 13–17, 2014, at the Hilton Orlando Lake Buena Vista, in Orlando, Florida. This year''s theme is “Integrating Environmental, Genomic, and Health Research.” The meeting will provide a forum for the latest research on DNA damage and repair, mechanisms of mutagenesis, epigenetic regulation, and their contributions to environmentally–induced human disease. In addition, current regulatory issues and risk assessment strategies will be discussed. EMGS is unique in that it provides a platform for the cross-disciplinary integration of basic and applied sciences that provide an understanding of the impact of genetic toxicity on human populations. The goals of this meeting are to 1) build on our past contributions to the field of environmental and molecular mutagenesis and DNA repair and more fully understand the role of epigenetics in these basic mechanisms; 2) integrate applied genetic toxicology with basic research in DNA damage and repair, toxicogenomics, and epigenetics; 3) determine how emerging technologies can lead to a better understanding of environmentally-induced genetic disease; 4) have these data serve as a foundation for human risk assessment for disease and disease prevention; and 5) aid in the support of knowledge-based regulation to protect public health and the environment. This is a meeting not to be missed. For additional information, visit the EMGS 2014 Annual Meeting website.

Event Type: Other Scientific Events
Organization: University of Louisville
Event Title: NIEHS Tamburro Symposium on Environmental Chemicals and Liver Disease
Event Date or Start Date: 9/11/2014
End Date: 9/12/2014
Country: UNITED STATES
State or Region: KY
Meeting Web Site: liversymposium.org
Additional Meeting Information: The Tamburro Symposium is the 1st dedicated conference on environmental chemicals and liver disease. It will be held at the University of Louisville’s new Clinical and Translational Research Building. Highlights of the two day conference include nearly 30 total lectures on (1) mechanisms of liver injury and fibrosis, (2) hepatic xenobiotic metabolism, (3) halogenated aliphatics and metals, (4) polycyclic aromatic hydrocarbons, (5) chemical carcinogenesis, and (6) alternative testing strategies. Key thought leaders including physicians and scientists from 13 institutions representing both academia and government will lecture. These speakers represent the largest concentration of thought leaders ever assembled with the purpose of defining the state of environmental hepatology. Abstract submission is open, and there will be a judged poster session.

Event Type: Other Scientific Events
Organization: Medetarian Conferences Organizing
Event Title: 5th Generic Medicine & Biosimilars Middle East Summit September 10th and 11th, 2014
Event Date or Start Date: 9/10/2014
End Date: 9/11/2014
Country: UNITED ARAB EMIRATES
State or Region: WI
Meeting Web Site: www.mco.ae/GenericMedicine/
Additional Meeting Information: The theme of this year is to host a variety of speakers to have a meaningful discussion around recent specific challenges and solutions in generics and biosimilars, particularly related to production and patents in the Middle East and around the globe. We have an exciting agenda planned.

Event Type: Other Scientific Events
Organization: Charles River
Event Title: 20th Annual Charles River Biotechnology -Derived Therapeutics Perspectives on Nonclinical Development
Event Date or Start Date: 9/8/2014
End Date: 9/10/2014
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.criver.com/info/biotech14
Additional Meeting Information: Where: Estancia La Jolla Hotel & Spa – La Jolla, California

What: Two and half days in an interactive setting to discuss the nonclinical development of biologics, regulatory issues and innovative approaches to problem-solving. The symposium includes an afternoon to examine hypothetical case studies on biopharmaceutical development dilemmas.

Event Type: Webinars
Organization: Compliance Trainings
Event Title: Webinar on Current Good Manufacturing Practices (cGMP) for Medical Devices and IVDs
Event Date or Start Date: 9/8/2014
End Date: 9/8/2014
Country: CANADA
State or Region: OH
Meeting Web Site: compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1353
Additional Meeting Information:

This 60-min webinar will help you ensure if you engage in the best practices for establishing and maintaining quality management systems necessary to achieve compliance and to remain compliant with 21 CFR Part 820 (cGMPs).



Areas Covered in the Session :
Applicable Laws
FDA Quality System Regulations
Definitions
Design Control: Design And Development Planning, Design Output, Design Review, Design Verification, Design Validation, Design Transfer, And Design Changes
Design History File (DHF)
Quality System Procedures, Purchasing Controls And Servicing Inspection, Measuring And Test Equipment
Process Validation
Corrective And Preventive Action (CAPA) And Complaint Files
Quality Requirements For Premarket Approval (PMA) Application
Device History Record (DHR) And Device Master Record (DMR)
Mistakes While Implementing QSRs
How to Avoid Mistakes
Frequent Citations in 483s and How to Avoid
Top 20 Items Cited in 483s
Lessons Learned: Best Practices

Who Will Benefit:
CEOs
VPs
Compliance Officers
Attorneys
R&D and Manufacturing Managers
Managers (RA, QA/QC, CA)
Consultants
Contractors and Subcontractors

Price tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com


Event Type: Other Scientific Events
Organization: LD Organisation
Event Title: XXIII International Symposium on Medicinal Chemistry (EFMC-ISMC 2014)
Event Date or Start Date: 9/7/2014
End Date: 9/11/2014
Country: PORTUGAL
State or Region: Lisbon
Meeting Web Site: atnd.it/8190-0
Additional Meeting Information: The XXIII International Symposium on Medicinal Chemistry (EFMC-ISMC 2014) will be organised by the Group of Medicinal Chemistry of the Portuguese Chemical Society (SPQ) on behalf of the European Federation for Medicinal Chemistry (EFMC). The symposium will take place at the Lisbon Congress Center from September 7-11, 2014.

The 2014 edition will continue the tradition established by these biennial symposia and will cover drug discovery advances in the major therapeutic areas, including neglected diseases, CNS disorders, inflammation, metabolic disorders, and oncology. EFMC-ISMC 2014 will present the most recent advances in lead identification and optimization strategies, drug design and profiling technologies, and illustrate the impact of biomarkers and imaging at the interfaces between chemistry, biology and experimental medicine. Particular emphasis will be put on first time disclosures, recent highlights in medicinal chemistry, and organic synthesis which had a strong impact on medicinal chemistry.

Event Type: Other Scientific Events
Organization: Charles River
Event Title: What is the NOAEL?!! (establishing an NOAEL when the data is not always clear)
Event Date or Start Date: 9/7/2014
End Date: 9/7/2014
Country: UNITED STATES
State or Region: CA
Meeting Web Site: www.criver.com/info/biotech14
Additional Meeting Information: The “no observable adverse effect level” (NOAEL) has been used for communicating results of animal data to clinicians and regulators. For biotechnology-derived therapeutics, effects observed in preclinical studies are often the result of intended exaggerated pharmacology, therefore identifying ADVERSITY and a NOAEL can be a challenging and controversial endeavor.

This interactive workshop is intended to discuss the concepts of adversity and NOAEL, and their application using a case-based approach on a variety of controversial drug development scenarios, so that participants can share and learn from their collective experiences.

Event Type: Other Scientific Events
Organization: GlobalCompliancePanel
Event Title: Global Medical Device Regulation: US, EU and Canada at Chicago IL
Event Date or Start Date: 9/4/2014
End Date: 9/5/2014
Country: UNITED STATES
State or Region: IL
Meeting Web Site: bit.ly/1k8aYkz
Additional Meeting Information: This course provides an overview of international medical device regulations. Beginning with a discussion of the similarity of global requirements, including both voluntary and mandatory standards and directives, and progressing to in-depth analyses of market specific requirements, the course provides the student with resources to meet the regulatory requirements for the largest world markets. Country-specific regulatory requirements for Canada, EU, and US are included.

Event Type: SOT Sponsored Non-SOT Meeting
Organization: NICEATM, EURL ECVAM, PCRM
Event Title: Adverse Outcome Pathways: From Research to Regulation
Event Date or Start Date: 9/3/2014
End Date: 9/5/2014
Country: UNITED STATES
State or Region: DC
Meeting Web Site: ntp.niehs.nih.gov/?objectid=6E7CB4EB-9DF3-CAC8-0D4931BB64F373D1
Additional Meeting Information: The traditional model of toxicology testing, which involves treating animals with test substances and observing outcomes, may not be sufficient to serve future scientific and regulatory needs. The science of toxicology is turning towards a new model, based on a better understanding of toxicity mechanisms, that will enable prediction of toxic effects in humans. A key element of a mechanistic understanding of a specific toxicity is the construction of an adverse outcome pathway for that toxicity.

An adverse outcome pathway is a conceptual framework constructed from existing knowledge that relates exposure of a type of toxic substance to subsequent steps that result in illness or injury.

Effective communication between researchers and regulators is often a critical determinant of whether new methods or approaches are efficiently translated from the scientific bench to regulatory decision-making practice.

This workshop will explore how interaction and collaboration among stakeholders can be initiated and maintained so that scientific progress in adverse outcome pathway concepts may improve regulatory assessment of chemical toxicity.

A large portion of the agenda is devoted to moderated breakout groups and whole-group discussion.

Opportunities for poster presentation, Trainee Travel Awards, and Poster Presentation Awards will be offered. The submission deadline for all of these is July 28. Check web site for more details and a draft workshop program.

No registration fee is required. Space may fill so register early; the registration deadline is August 15.

Event Type: Other Scientific Events
Organization: GlobalCompliancePanel
Event Title: DHF, DMR, DHR, TECHNICAL FILE AND DESIGN DOSSIER – KEY REQUIREMENTS AND FUTURE DIRECTIONS
Event Date or Start Date: 8/28/2014
End Date: 8/29/2014
Country: UNITED STATES
State or Region: NV
Meeting Web Site: bit.ly/1mKTZj4
Additional Meeting Information: This seminar/workshop will examine the existing and proposed requirements for the US FDA's DHF—including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements, and evaluate the documents differing purposes/goals, their similarities, as well as the two different device classification schemes. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation/update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the




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