- 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