Course offering number:1202-406
Course ID:
1153
Non-Clinical Drug Safety Evaluation and Drug Development
February 22-24, 2012
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 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.