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European Summit
Kongresshaus Zürich
Zürich, Switzerland

Practical Issues and Considerations

The Post-Approval Summit, held annually at the Harvard Medical School in Boston, MA, presents a 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.


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