September 16, 2010
The University of Basel, School of Pharmacy
Basel, Switzerland

Practical Issues and Considerations

The Post-Approval Summit, held annually at the Harvard Medical School in Cambridge, MA, presents its first practically focused European event. This one day, case-based program at The School of Pharmacy (Biozentrum/Pharmazentrum) at the University of Basel in Basel, Switzerland 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.

2010 Program Highlights

Designing effective studies
Epidemiology and statistical considerations
Practical operational considerations
Managing post-approval specific regulatory hurdles
Evaluation criteria and implications for meeting regulatory requirements and publications
Real-world case studies
An interactive workshop