FDA Regulatory Affairs

DOUGLAS J. PISANO is Dean of the School of Pharmacy and Professor of Pharmacy Administration, Massachusetts College of Pharmacy and Health Sciences, Boston, Massachusetts, USA. Dr. Pisano received his Ph.D. in Law, Policy, and Society at Northeastern University, Boston, Massachusetts, USA. He is an active member of several professional organizations, including the American Association of Colleges of Pharmacy and the American Pharmaceutical Association. A national speaker and invited lecturer, Dr. Pisano was the recipient of the Special Service Award for the Enhancement of Regulatory Education from the Regulatory Affairs Professionals Society in 2000. He has developed several courses and programs at the Massachusetts College of Pharmacy and Health Sciences in such areas as health policy, pharmacy and drug law, and regulatory affairs. Dr. Pisano, along with coeditor Dr. David S. Mantus, is also the editor of the first edition of Informa Healthcare’s FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics. DAVID S. MANTUS is Vice President of Regulatory Affairs and Program Management, Cubist Pharmaceuticals, Inc., Lexington; Adjunct Professor of Drug Regulatory Affairs, Massachusetts College of Pharmacy and Health Sciences, Boston; and President, C After D Inc., Boston, Massachusetts, USA. Dr. Mantus received his Ph.D. in Chemistry from Cornell University, Ithaca, New York, USA. He is an active member of the Regulatory Affairs Professional Society and the American Chemical Society and is a frequent presenter and lecturer at national conferences on biologics and biotechnology, regulatory affairs, and vaccine development. Dr. Mantus has also served as chairperson for several conferences, including "Outsourcing Regulatory Affairs" and "Vaccine Development for the 21st Century."

1. Overview of Drug Development and the FDA. 2. IND. 3. Formatting, Assembling, And Submitting A CTD (NDA). 4. Meeting with the FDA. 5. Biologics. 6. FDA Medical Device Regulation. 7. The Development of Orphan Drugs. 8. Chemistry, Manufacturing and Control Issues: Drugs and Biologics. 9. Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices. 10. The Regulation of Promotional Materials and Advertising for Drugs. 11. CTD Submissions: A Guide for Electronic Regulatory Submissions to FDA. 12. The Practice of Regulatory Affairs. 13. A Primer Of Drug/Device Law Or What's The Law And How Do I Find It? 14. Advisory Committee System at FDA.