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Non-Clinical Drug Safety Evaluation and Drug Development

 
  November 01, 2007  
     
 
The Center for Professional Advancement, New Brunswick, NJ
February 27-29, 2008


Who Should Attend
This course is designed for a broad range of pre-clinical, clinical, management, investment, and regulatory personnel in both established and emerging pharmaceutical companies. It will be of special value to:
  • Scientists who wish to gain an understanding of pharmaceutical toxicity studies
  • Managerial personnel
  • Project management staff
  • Regulatory Scientist involved in preclinical development
  • Investors

Description
This course provides a comprehensive explanation of the nonclinical development of drugs and biologics, emphasizing the principles of pharmaceutical toxicology and the assessment of product safety. In addition to the different types of toxicity studies in modern pharmaceutical development, it also describes the relationship between pharmacology, clinical trial design, regulatory strategy and project management.

Emphasis will be placed on how toxicity studies are integrated into the multidisciplinary development plans of new drugs and biologics, and how they affect development decisions. Regulatory affairs will be covered, and descriptions given of the European and the U.S. FDA requirements, the new drug review process, and common regulatory errors.

The goal of this course is to give a working knowledge of pharmaceutical toxicology and drug development to enable you to develop new drugs faster and more efficiently.

There will be ample opportunities for participants to introduce topics for discussion and to interact with the faculty. The “IND Game” will provide practical experience in early drug development.

 
 
Organized by: The Center for Professional Advancement
Invited Speakers: Dr. Shayne C. Gad, Principle of Gad Consulting Services

Dr. Shayne C. Gad has been Principle of Gad Consulting Services for 15 years. His 30 years of experience includes safety assessment in the medical device, biotechnology, pharmaceutical and chemical industries. He has published 34 books and more than 300 abstracts, articles, and chapters in the fields of toxicology, statistics and safety assessment, pharmaceutical and medical device development, and is on the editorial boards of the Journal of Applied Toxicology, The International Journal of Toxicology, and the Journal of Acute Toxicology. He is Editor-in-Chief for Toxicology Methods, and has successfully opened 85 INDs in the past 15 years. He served on the Consumer Product Safety Commission Toxicology Advisory Board, and numerous NIH review committies and Advisory Boards.

Dr. Gad received his Ph.D in Pharmacology/Toxicology from the University of Texas at Austin and is a Diplomate of the American Board of Toxicology and a Fellow of the Academy of Toxicologic Sciences. He is a Past President of the American College of Toxicology, three SOT specialty sections and the Roundtable of Toxicology Consultants.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: info@cfpa.com
 
   
 
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