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Toxicology for Industrial and Regulatory Scientists

Course Description

This annual ACT course 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.

This course is supported by the Society of Toxicology.

Course Flyer

Course Schedule

Monday, April 27

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, Russell Bialecki, AstraZeneca Pharmaceuticals

Tuesday, April 28

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, Robert Hall, Covance Laboratories Inc.

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

Wednesday, April 29

Genetic Toxicology, Mark Powley, US Food and Drug Administration

Evaluation of Potential Carcinogenicity, James Popp, Stratoxon LLC

Reproductive/Developmental Toxicology, Kok Wah Hew, Takeda Global Research & Development Center, Inc.

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

Thursday, April 30

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, Ernie Harpur, Newcastle University, UK

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

Friday, May 1*

Regulatory Toxicology of Chemical, Agrochemicals, and Other Nonpharmaceuticals, William Brock, Brock Scientific Consulting, LLC

Review of Drug F: 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. Must bring personal computer to view materials.

Times

Registration and Course Material Pick-Up: 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 Global Research & Development Center, Inc.
Hanan Ghantous, PhD, DABT, US FDA
Kenneth Olivier, PhD, Merrimack Pharmaceuticals
Timothy McGovern, PhD, US FDA

Registration

Online Registration
Registration Form

Registration Fees

  By March 2 March 3–April 24
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 3/2/15; 50% refund if canceled before 3/24/15; After 3/24/15 no fees will be refunded.

Location

The course is held at the MedImmune Headquarters
One MedImmune Way
Gaithersburg, MD 20878
United States

Hotel

Courtyard Gaithersburg Washingtonian Center
204 Boardwalk Place
Gaithersburg, MD 20878
Tel: 301.527.9000
Hotel Reservation: 800.321.2221
ACT Room Block Rate: $165, plus tax

Housing Deadline:

The deadline for housing reservations is Monday, April 6, 2015.

Other

A special bus will take course participants from the Marriott to the course site at MedImmune Headquarters. If you plan to use your own transportation and park at the MedImmune Campus, please indicate so on the Registration Form, so space may be reserved.

This course provides materials electronically and a laptop is strongly encouraged.

A photo ID will be required to enter the MedImmune campus.


















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