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Course offering number:0809-306
Course ID:
1153
Non-Clinical Drug Safety Evaluation and Drug Development
September 15-18, 2008
Burlingame, CA
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 and
biopharmaceutical 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 Scientists involved in preclinical development
- Investors
Description
This course provides a comprehensive explanation of the nonclinical
development of drugs, biologics and combination
products, 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
completely revised “IND Game” will provide practical
experience in early drug development through Phase 1.