Mark your calendar! The 7th Annual Post-Approval Summit will take place on May 10-11, 2011 in Boston, MA.

The 2011 Post-Approval Summit, held annually at Harvard Medical School, will cover the industry’s most pressing topics surrounding post-approval research, real-world studies, and patient registries, including:

• A New Era of Real-World Research
• Key Initiatives Changing the Face of Product Safety and Surveillance
• Benefit-Risk Management and REMS: Practical and Strategic Considerations
• Understanding Comparative Effectiveness Research

We are pleased to announce a keynote presentation by Dr. Janet Woodcock, Director for the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA), on the status and the impact of recent post-approval initiatives and changes at the FDA over the past three years, including Risk Evaluation and Mitigation Strategies (REMS) and new approaches to evidence synthesis for safety and effectiveness, and how the FDA is evolving from binary decision making to ongoing monitoring and evaluation.

Agenda Posted!

Confirmed presenters represent CMS, FDA, European Medicines Agency, NICE, NIH, Canadian Institutes of Health Research, Celgene, Takeda Global Research and Development Center, King Pharmaceuticals, Merck, Medtronic, Harvard Medical School, CVS Caremark Corporation, Consumers Union, Outcome, and more.

Please visit the Summit website at http://www.postapproval.org or call 617-621-6426 to view the full agenda or to register.

We look forward to seeing you in May!

The Committee for the Post-Approval Summit
2201 Broadway, Cambridge, MA 02139
Tel: (617) 621-6426
Fax: (617) 621-1620
mailto: [email protected]