Discussion Leaders and Presenters

• Andrew von Eschenbach, Commissioner of Food and Drugs
• Jeffrey Leiden, MD, Ph.D. Former Chief Operating Officer, Abbott Laboratories
• Tor Graberg, Head of Drug Inspectorate, Medical Products Agency, Sweden
• David Horowitz, JD, Deputy Associate Commissioner for Regulatory Affairs, FDA
• Dr. Cledwyn Davies, Health Protection Agency, United Kingdom
• Thomas Barker, Unit Head, Inspections, Health Canada
• Joseph Famulare, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, FDA
• Mark Paxton, Associate Vice President, International Regulatory Affairs, PhRMA
• Gerry Migliaccio, Vice President, Global Quality Operations, Pfizer
• David Chesney, PAREXEL Consulting
• Edwin Rivera, Acting Director , Division of Manufacturing and Quality, CDER, FDA
• Leigh Hayes, JD, Office of Combination Products, FDA
• James Cohen, Office of Combination Products, FDA
• Phillip Campbell, Senior Compliance Officer, FDA
• Bob Coleman, National Drug Expert, FDA (retired)

DISCLAIMER: ALL Invited speakers have accepted BUT are on a “Subject to Availability” condition