The Center for Professional Advancement, Millbrae, CA
September 5-7, 2007
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 toScientists 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.
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