| 8:15-9:00 |
Keynote: Envisioning the Future of Safety and Effectiveness To Be Announced |
| 9:00-9:45 |
Keynote: Adjusting for Success: The Impact of the Evolving Post-Approval Landscape Michael Rosenblatt, MD, Executive Vice President and Chief Medical Officer, Merck & Co., Inc. |
| 9:45-10:00 |
Break
|
| 10:00-10:45 |
Evolving Role and Expectations for REMS and Safety Programs Gerald Dal Pan, MD, MHS, Director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration (FDA) |
| 10:45-11:30 |
European Updates to Risk Management Stella Blackburn, MA, MSc, FRCP(Ed), FFPM, Risk Management Development and Scientific Lead, European Medicines Agency |
| 11:30-12:00 |
Case Study: Using a Registry for REMS and PASS Requirements Eleanor Segal, MD, Vice President and Head Global Drug Safety, Actelion Pharmaceuticals |
| 12:00-1:15 |
Lunch |
| 1:15-2:00 |
Designing Safety Studies: Interventional vs Observational Sharon-Lise Normand, PhD, Professor of Health Care Policy, Harvard Medical School and Harvard School of Public Health |
| 2:00-2:45 |
Challenges of Device Tracking and Adverse Event Reporting Richard E. Kuntz, MD, Senior Vice President, Chief Scientific, Clinical and Regulatory Officer, Medtronic |
| 2:45-3:30 |
Integrating Risk Management Planning into the Regulatory Decision-Making Process Marc Berthiaume, MD, Director, Marketed Pharmaceuticals and Medical Devices Bureau, Health Canada
|
| 3:30-3:45 |
Break |
| 3:45-5:00 |
New Innovations in Safety Stella Blackburn, MA, MSc, FRCP(Ed), FFPM, Risk Management Development and Scientific Lead, European Medicines Agency
Nancy Dreyer, MPH, PhD, Chief of Scientific Affairs and Senior Vice President, Outcome
Michael Ibara, PharmD, Head of Pharmacovigilance Information Management, Pfizer, Inc. |
| 5:00-5:30 |
Case Study |
| 5:30-6:15 |
Molecular Networks: The New Grammar of Medicine Mark Fishman, MD, President, Novartis Institute for Biomedical Research |
| 6:15 |
Opening Night Reception Isabella Stewart Gardner Museum Attendees are invited to attend the opening night reception at the Isabella Stewart Gardner Museum on May 11 following the close of sessions. The reception offers attendees the opportunity to see this beautiful, world-renowned museum while networking with colleagues, speakers, and other attendees. Hors d'oeuvres, beverages, and musical entertainment will be provided and all galleries will be open to view, with docents onsite to answer any questions on the art or history of the museum. |