American College of Toxicology


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Educational Courses

Toxicology for Pharmaceutical and Regulatory Scientists

Course Description

This annual ACT course, formerly titled Toxicology for Industrial and Regulatory Scientists, provides basic training in general toxicology. Using pharmaceutical development as examples, participants will obtain an overall understanding of the principles of toxicology and nonclinical safety evaluation. 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.

Course Flyer

Course Schedule

Monday, April 25

Principles of Toxicology, A. Wallace Hayes, Harvard School 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 Industrial Toxicology, Matthew Bogdanffy, Boehringer-Ingelheim Pharmaceuticals, Inc.

Safety Pharmacology for Human Pharmaceuticals, Simon Authier, CiToxLab North America

Please join us for a reception following the class on Monday, April 25. This light-fare reception, which is included in the registration fee, allows for fellow course attendees, course organizers, and speakers to interact and network in a casual atmosphere. Hot and cold hors d’oeuvres, plus drink tickets will be provided.

Tuesday, April 26

General Toxicology, Lorrene Buckley, Eli Lilly & Company

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

Clinical Pathology: Principles for Industrial and Regulatory Scientists, Denise Bounous, Bristol Myers Squibb Company

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

Wednesday, April 27

Genetic Toxicology, Mark Powley, US Food and Drug Administration

Evaluation of Potential Carcinogenicity, James Popp, Stratoxon LLC

Reproductive/Developmental Toxicology, Kok Wah Hew, Takeda Pharmaceutical International Co.

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

Thursday, April 28

Nonclinical Safety Evaluation of Biotechnology-Derived Therapeutics, Melanie Hartsough, Biologics Consulting Group, Inc.

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

Risk Assessment, Melissa Rhodes, Roivant Sciences

Practical Application: Nonclinical Case Studies, Hanan Ghantous, US Food and Drug Administration

Friday, April 29*

Regulatory Submissions: Preparation of Nonclinical Documents, Paul Nugent, Pfizer, Inc.

Review of Drug G: History and Outcome, Kenneth Hastings, Hastings Toxicology Consulting, LLC

*Course ends at noon.

Daily continental breakfast, snack breaks, and lunch are provided as part of the registration. Detailed course handouts will be provided electronically. Participants must bring personal computer to view materials.


Registration and Check-in: Monday, 7:00 AM–8:00 AM

Course: Monday–Thursday, 8:00 AM–5:00 PM;
               Friday, 8:00 AM–12:00 Noon

Course Organizers

Course Director: Kok Wah Hew, PhD, DABT, Takeda Pharmaceutical International Co.
Hanan Ghantous, PhD, DABT, US Food and Drug Administration
Timothy McGovern, PhD, US Food and Drug Administration


The course is sold out. If you would like to be placed on a waiting list please contact ACT Headquarters at

Registration Fees:

  By Feb. 22 Feb. 23–April 22
ACT Member $1,295 $1,395
Nonmember $1,595 $1,695
Government $1,295 $1,395

Refund Policy:
$75 Processing Fee will be charged before 2/22/16; 50% refund if canceled before 3/22/16; After 3/23/16 no fees will be refunded.

Course Location

Gaithersburg Marriott Washingtonian Center
9751 Washingtonian Boulevard
Gaithersburg, MD 20878
Tel: 301.590.0044


Gaithersburg Marriott Washingtonian Center
9751 Washingtonian Boulevard
Gaithersburg, MD 20878
Tel: 301.590.0044
Hotel Reservation: 800.393.3450

Housing Deadline:

Please refer to the ACT TPRS Room Block, April 24–29, 2016. You must book by March 28, 2016, to receive the group rate.


A personal laptop to view course materials and your computer charger. We also suggest downloading all the course material to your laptop prior to arriving at the course. TPRS course material will be provided approximately one week before the start of the course.

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