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
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.