Events

Update: The UK’s Medicines and Healthcare Products Regulatory Agency

Speaker(s):
David R. Jones, Retired, Expert PharmacoToxicologist, Medicines and Healthcare products Regulatory Agency

Materials:
Webinar Recording
David R. Jones Presentation

Risk Evaluation of Nongenotoxic Carcinogenic Pharmaceuticals: Impact of The ICH S1B Addendum, A European Viewpoint

Speaker(s):
Jan Willem van der Laan, PhD, Medicines Evaluation Board, European Medicines Agency Representative, ICH S1 Carcinogenicity Regulatory Chair

Materials:
Webinar Recording
van der Laan Presentation

Considerations Regarding Nonhuman Primate Use in Pharmaceutical Development

Speaker(s):
Ronald Wange, PhD, Associate Director for Pharmacology and Toxicology, OND, CDER

Materials:
Webinar Recording
Wange Presentation

Safety of COVID-19 Therapies and Vaccines

Speaker(s):
Kenneth L. Hastings, DrPH, DABT, ATS, Hastings Toxicology Consulting LLC

Materials:
Webinar Recording
Hastings Presentation

Membership Meet & Greet 2022

Cannabis: A Review of the Current State of Safety and Regulatory Considerations

Speaker(s):
Tom Jonaitis, DABT
Garrett Graff, Esq.

Materials:
Webinar Recording
Tom Jonaitis, DABT Presentation
Garrett Graff, Esq. Presentation

Assessment of Adversity and NOAEL in Toxicology Studies to Support Regulatory Decision

Speaker(s):
John L. Vahle, DVM, PhD, DACVP
Vincent Meador, DVM, PhD, DACVP

Materials:
Webinar Recording (Unavailable)
Dr. Vahle Presentation
Dr. Meador Presentation

Finding Your Dream Job in Regulatory Toxicology

Speaker(s):
Edward V. Ohanian, PhD
Amy L. Roe, PhD, DABT
Anne E. Loccisano, PhD, DABT

Materials:
Webinar Recording (Unavailable)
Dr. Ohanian Presentation
Dr. Roe Presentation
Dr. Loccisano Presentation

Updates for FDA’s GLP Regulations

Speaker(s):
Mark Seaton, PhD, DABT, US FDA

Materials:
Webinar Recording (Unavailable)
Dr. Seaton Presentation

First-in-human studies: Recent experiences in Europe

Speaker(s):
Jan Willem van der Laan, Medicines Evaluation Board, Utrecht, The Netherlands
David Jones, MHRA, London, United Kingdom

Materials:
Jan Willem van der Laan Presentation
Lutz Müller Presentation

EPA’s Guidelines and Other Related Activities for Cyanotoxins

Speaker(s):
Lesley V. D’Anglada, DrPH, MEH, US Environmental Protection Agency, Washington, DC

Precautionary Principle = Risk Assessment (or Not)?

Speaker(s):
Professor Christopher Portier, PhD, FASA, FISI, FWIF, Thun, Switzerland
Professor Alan R. Boobis, OBE, PhD, FRSB, FBTS, Imperial College, London, UK

CTA/NDA Regulatory Landscape in China

Speaker(s):
Dr. Jianxun (Jack) Xie, PhD, DABT, Director, Head of Toxicology, Roche Innovation Center Shanghai (China)

Materials:
Presentation

The Integration of LNT and Hormesis for Cancer Risk Assessment Optimizes Public Health Protection

Speaker(s):
Edward J. Calabrese, Ph.D.

Materials:
Webinar Recording (Unavailable)
Presentation

Global Regulatory Toxicology: First Stop EU

Speaker(s):
Beatriz Silva Lima, Universidade de Lisboa, PT, IMI Scientific Committee, BE, NDA Advisory Board, UK

Materials:
Presentation

Can/Should Peer-Reviewed Publications Be Used to Formulate Regulatory Policy?

HA Mutagen Is a Carcinogen Because It Is a Mutagen

Hazard Information Provides an Adequate Basis for Restricting Chemical Use

Speaker(s):
RSESS Past President James C. Lamb, IV, of Exponent
George Gray, George Washington University
Lorenz Rhomberg, Gradient Corporation

Materials:
Debate Flyer

Are the Blind Leading the Blind or Are Pathologists Biased? A Debate on the Pros and Cons of Blinded Histopathology Evaluation for the Qualification of New Biomarkers of Toxicity

Speaker(s):
B. Short
K. Pandher
B. Maronpot

Materials:
B. Short Presentation
K. Pandher Presentation
B. Maronpot Presentation

Limit the Use of the Non-Rodent in Toxicity Testing: Scientific Considerations

Speaker(s):
Monticello
Olson

Materials:
Monticello Presentation
Olson Presentation

MTD: Is Testing to the MTD Unnecessary Animal Use or Always Necessary to Assure Human Safety?

Speaker(s):
Reynolds
Osterberg
Sistare

Materials:
Reynolds Presentation
Osterberg Presentation
Sistare Presentation

Ten Years after the Food Quality Protection Act: Healthier Children or Unnecessary Burden?

Speaker(s):
Fenner-Crisp
Faustman
Bus

Materials:
Fenner-Crisp Presentation
Faustman Presentation
Bus Presentation

Animal and Human Testing: What’s Appropriate?

Speaker(s):
Doull
Sandusky
Rodricks

Materials:
Doull Presentation
Sandusky Presentation
Rodricks Presentation

Rodent Carcinogenicity Assay: Relevant or Relic?

Speaker(s):
Dr. Cohen
Dr. Jacob

Materials:
The Great Debate
Dr. Cohen’s Presentation
Dr. Jacob’s Carcinogenicity Prediction Article

Positive Genetic Toxicity Findings: Now What?

Speaker(s):
David Kram
Galloway
Gary Williams

Materials:
David Kram Presentation
Galloway Presentation
Gary Williams Presentation