Alexandria, VA -- AAPS is co-sponsoring the 1998 FDA Science Forum "Biotechnology: Advances, Applications, and Regulatory Challenges," with FDA and the FDA Chapter of Sigma Xi at the Washington Convention Center in Washington, D.C., Dec. 8-9, 1998.

The FDA Science Forum is open to the public and will bring FDA research and review scientists together with representatives of industry, academia, government agencies, consumer groups, and the public to discuss the impact of the enormous advances in biotechnology on product development and regulation. The program will encompass bioengineered products, novel therapeutic and preventive approaches, diagnostics and detection methodologies, and safety and efficacy assessment. The Forum will feature plenary lectures and focused discussion groups that include FDA, industry, and university leaders in the field on the following topics:

• Biofarming and Biopharming
• Diagnostics and detection methods
• Microbial pathogens, antibiotics, and resistance
• Therapeutic and preventive agents
  • Gene therapy
  • Cell and tissue engineering
  • Vaccines
• New models/methods for safety and efficacy assessment
• Regulatory challenges
  • Translating scientific advances into regulatory action
  • Public acceptance of novel products

A poster session featuring all areas of FDA regulatory science will be presented to provide an opportunity for interested scientists to engage in information exchange with FDA scientists.

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Contact: Amy Miller
miller@aaps.org
703-518-8417
American Association of Pharmaceutical Scientists
27-Oct-1998