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.
- 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