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Toxicology for Industrial and Regulatory Scientists

Course Description

Held at MedImmune Headquarters, this annual ACT course provides basic training in toxicology. 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 chemical, biotechnology and pharmaceutical companies, CROs, 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 28

Principles of Toxicology, A. Wallace Hayes, Harvard University
Pharmacology, Amy Avila, US FDA
Pharmacokinetics/ADME in Toxicology, Matthew Bogdanffy, Boehringer-Ingelheim Pharmaceuticals, Inc.
Safety Pharmacology, Russell Bialecki, AstraZeneca

Tuesday, April 29

General Toxicology, Lorrene A. Buckley, Eli Lilly & Company
Toxicity of Organ Systems, Mary Beth Genter, University of Cincinnati
Clinical Pathology in Toxicology Studies, Robert Hall, Covance Laboratories, Inc.
Pathology in Toxicology Studies, Jerry Hardisty, EPL

Wednesday, April 30

Genetic Toxicology, Mark Powley, US FDA
Carcinogenicity, James Popp, Stratoxon LLC
Reproduction/Developmental Toxicology, Kok Wah Hew, Takeda Global Research & Development Center, Inc.
Immunotoxicology, Jeanine Bussiere, Amgen, Inc.

Thursday, May 1

Evaluation of Biotechnology-Derived Therapeutics, Melanie Hartsough,Biologics Consulting Group, Inc.
Regulatory Toxicology, Hanan Ghantous, US FDA
Risk Assessment, Ernie Harpur, Newcastle University
Practical Application: Nonclinical Case Studies, Hanan Ghantous, US FDA

Friday, May 2*

Regulatory Toxicology/Risk Assessment of Chemical, Agrochemicals, and Other Nonpharmaceuticals, William Brock, Brock Scientific Consulting LLC
Workshop with Course Moderators: Nonclinical Assessment of Drug E

*Course ends at noon.

Daily continental breakfast, snack breaks, and lunch are provided as part of the registration. Detailed course handouts will be provided on a thumb drive.

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 Pharma
Timothy McGovern, PhD, US FDA

Registration

Online Registration
Registration Form

As of April 8, 2014 only 9 seats remain.

Registration Fees

  By March 3 March 4–April 25
ACT Member $1295 $1395
Nonmember $1595 $1695
Government $1295 $1395

 

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
301.527.9000
800.228.9290

Housing Deadline:

The deadline for housing reservations is Monday, April 7, 2014.

Online Group Reservations

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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