September 11-12, 2012
Kongresshaus Zürich
Zürich, Switzerland

Practical Issues and Considerations

The Post-Approval Summit, held annually at the Harvard Medical School in Boston, MA, presents its third annual practically focused European event. The European Post-Approval Summit is a case-based program that will focus on designing and operating high quality patient registries and post-approval studies in Europe and how they will be evaluated by other stakeholders.

2012 Program Highlights

Updates to international post-approval regulations
Challenges with implementing safety, risk management, and effectiveness studies
Benefits and limitations with different approaches for meeting post-approval requirements
Local challenges and considerations with emerging markets
Recent initiatives in market access and HTA
Aligning regulatory and payer needs for data