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Toxicology for Industrial and Regulatory Scientists

Course Description

This course, taught by distinguished experts, is designed to provide a basic training in toxicology. Participants will obtain an overall understanding of the principles of nonclinical safety evaluation with emphasis on the practical application of these principles and interpretation of nonclinical safety data. The course will include discussion of regulatory case studies and a workshop. The course is intended to benefit individuals working in pharmaceutical, biotechnology and chemical/agrochemical companies, Contract Research Organizations and regulatory agencies who are interested in or currently practicing toxicology.

The course has been highly successful and well received. The course participants were from US and Europe and included toxicologists from pharmaceutical, biotechnology, CROs and regulatory agencies; individuals looking to enter the pharmaceutical sector; individuals involved in drug development but without previous toxicology training; and those without toxicology training who wanted to gain a broader drug development experience (quality assurance and program managers).

Benefits of attending the toxicology course

  • Interaction with highly distinguished faculty representing pharmaceutical and biotechnology industries, consultants and regulatory authorities.
  • Learn to apply practical applications in development of pharmaceutical and biologic therapeutics learned from the class room
  • Practice with real-life drug development examples
  • Interact with other scientists from diverse backgrounds
  • Practice working in a team to address specific questions about a program
  • Enhance your career opportunities.

Course brochure
Course flyer

Course Schedule

Monday, April 22

Basic Principles of Toxicology, A. Wallace Hayes, Harvard University
Regulatory Toxicology, Tracy Zoetis, SciLucent LLC
Pharmacology, Amy Avila, US FDA
Safety Pharmacology, Russell Bialecki, AstraZeneca

Tuesday, April 23

General Toxicology, Jon Daniels, Intrinsik Science
Toxicity of Organ Systems, Mary Beth Genter, University of Cincinnati
Clinical Pathology in Toxicology Studies, Robert Hall, Covance
Pathology in Toxicology Studies, Jerry Hardisty, EPL

Wednesday, April 24

Genetic Toxicology, Mark Powley, US FDA
Carcinogenicity, James Popp, Stratoxon
Reproduction/Developmental Toxicology, Kok Wah Hew, Takeda
Immunotoxicology, Jeanine Bussiere, Amgen

Thursday, April 25

Pharmacokinetics/ADME in Toxicology, Matthew Bogdanffy, Boehringer-Ingelheim
Safety Evaluation of Biotechnology Products, Melanie Hartsough, BCG
Risk Assessment, Ernie Harpur, Newcastle University
Practical Applications: Nonclinical Case Studies, Hanan Ghantous, US FDA

Friday, April 26*

Regulatory Toxicology and Risk Assessment of Chemicals and Agrochemical Products, William Brock, Brock Scientific Consulting LLC
Nonclinical Assessment of Drug D: A Special Workshop of Drug Development from IND to NDA,

Hanan Ghantous, US FDA
Kenneth Hastings, Sanofi-Aventis
Timothy McGovern, SciLucent LLC
Tracey Zoetis, SciLucent LLC

*Course ends at noon.

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

Course Organizers
Kok Wah Hew, PhD, DABT, Takeda
Hanan Ghantous, PhD, DABT, US FDA
Kenneth Olivier, PhD, Merrimack Pharma
Timothy McGovern, PhD, SciLucent LLC

Registration

Register online
Registration form

Location

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

Lodging may be reserved at the Gaithersburg Marriott Washintonioan Center, 9751 Washingtonian Boulevard, Gaithersburg, MD, 20878, 888.236.2427

A special bus will take course participants from the Marriott to the course site at MedImmune Headquarters.


















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