American College of Toxicology


= Members Only

Educational Course—Virtual Format in 2021!

Toxicology for Pharmaceutical and Regulatory Scientists

Course Description

This annual ACT course provides basic training in general toxicology. Participants will obtain an overall understanding of the principles of toxicology and nonclinical safety evaluation with a focus on pharmaceutical development. New this year, the course will include Cell and Gene Therapy. By popular demand, the course will include discussion of regulatory case studies and hands-on analyses of nonclinical data. The course is intended to benefit individuals working with small and large molecules from biotechnology and pharmaceutical companies, CROs, and regulatory agencies, or individuals interested in or currently practicing toxicology.

On-demand access to the presentations will be available to registrants for unlimited viewing no later than March 15 until April 9, 2021.

Virtual Features

  • Virtual interactive case studies and break out groups
  • Live Q&A Sessions with Speakers
  • Recorded lectures with unlimited on-demand viewing

Course Flyer

Virtual Course Topics

Recordings will be released to registered attendees once available. Register early for maximum access to lectures.

  Recorded Lectures  

Principles of ToxicologyA. Wallace Hayes, University of South Florida, College of Public Health

Introduction to Pharmacology for the Toxicologist, Amy Avila, US Food and Drug Administration

Principles of Drug Metabolism and Toxicokinetics and Applications to Pharmaceutical Toxicology, Debie Hoivik, Akebia Therapeutics

Safety Pharmacology for Human Pharmaceuticals, Mary Jeanne Kallman, Kallman Preclinical Consulting

General Toxicology, Lorrene Buckley, Eli Lilly and Company

Toxicology of Organ Systems, Mary Beth Genter, University of Cincinnati

Clinical Pathology: Principles for Pharmaceutical and Regulatory Scientists, Lila Ramaiah, Pfizer, Inc.

Pathology in Toxicology Studies, Thomas Steinbach, Experimental Pathology Laboratories, Inc.

Genetic Toxicology, Mark Powley, Merck & Co., Inc.

Evaluation of Potential Carcinogenicity, James Popp, Stratoxon LLC

Reproductive/Developmental and Juvenile Toxicology, Alan Hoberman, Charles River

Nonclinical Safety Evaluation of Biotechnology-Derived Therapeutics, Melanie Hartsough, Hartsough Nonclinical Consulting, LLC

Immunotoxicology, Florence Burleson, Burleson Research Technologies, Inc. (BRT)

Risk Assessment, Melissa Rhodes, Kriya Therapeutics

Regulatory Toxicology—A Nonclinical Pharmacology and Toxicology Perspective, Hanan Ghantous, US Food and Drug Administration

Cell and Gene Therapy, Sandhya Sanduja, US Food and Drug Administration

Preparation of Nonclinical Documents for Regulatory Submission, Marjorie Peraza, Pfizer, Inc.

  Live—Interactive Breakout Groups on April 2, 2021  

Practical Application: Nonclinical Case Studies 
Hanan Ghantous, US Food and Drug Administration
Natalie Holman, Eli Lilly and Company
Katie Sokolowski, US Food and Drug Administration


Live Q&A sessions and case studies with breakout group work with ACT Course speakers and moderators will take place the week of March 29–April 2, 2021 from 11:00 am to 1:00 pm Eastern Time. Click here for the live Q&A schedule.

Course Organizers

Joseph A. Francisco, PhD, Independent Consultant
Hanan Ghantous, PhD, DABT, US Food and Drug Administration
Timothy McGovern, PhD, US Food and Drug Administration
Jordan Ballance, ACT Staff Liaison


Registration Closed.

Virtual Registration Fees:

ACT Member $1,295
ACT Student or Postdoc/Transitional $   995
Nonmember $1,595
Government $1,295
ACT Member Group Rate** 
(3 or more from same company)
Nonmember Group Rate** 
(3 or more from same company)
ACT Member Group Rate** 
(10 or more from same company)
Nonmember Group Rate** 
(10 or more from same company)

**To take advantage of the group rate: Please send your completed registration forms to ACT Headquarters. You will not be able to select the group rate through the online registration. All three forms (or more) should be emailed at the same time.

Refund Policy: ACT will not offer refunds for virtual courses. Health-related refunds will be considered on a case-by-case basis. These special cancellation requests should be submitted in writing to ACT Headquarters. A $75 processing fee will be charged for cancellations.


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