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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 24

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 Pharmaceutical 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 course on Monday. 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. Hors d'oeuvres, plus drink tickets for beer and wine will be provided to registered participants.

Tuesday, April 25

General Toxicology, Lorrene Buckley, Eli Lilly & Company

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

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

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

Wednesday, April 26

Genetic Toxicology, Mark Powley, US Food and Drug Administration

Evaluation of Potential Carcinogenicity, James Popp, Stratoxon LLC

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

Reproductive/Developmental Toxicology, Kok Wah Hew, Takeda Pharmaceuticals USA, Inc.

Thursday, April 27

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

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 28*

Preparation of Nonclinical Documents for Regulatory Submission, Paul Nugent, Pfizer, Inc.

Review of Drug H: 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.

Times

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 Pharmaceuticals USA, Inc.
Hanan Ghantous, PhD, DABT, US Food and Drug Administration
Timothy McGovern, PhD, US Food and Drug Administration
Joseph A. Francisco, Charles River

Registration

This course is sold out. To be placed on the wait list, please contact ACT Headquarters at acthq@actox.org.

Registration Fees:

  By Feb. 20 Feb. 21–April 21
ACT Member $1,295 $1,395
ACT Student and Postdoc Member $ 995 $1,095
Nonmember $1,595 $1,695
Government $1,295 $1,395
ACT Member Group Rate
(3 or more from same company)
$1,145 $1,245
Nonmember Group Rate
(3 or more from same company)
$1,445 $1,545

Refund Policy:
$75 Processing Fee will be charged before 2/21/17; 50% refund if canceled before 3/21/17; After 3/21/17 no fees will be refunded.

Course Location

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

Hotel

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. You must book by March 27, 2017, to receive the group rate.

Requirements:

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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