Workshop on methods for efficacy studies in everyday medical practice

• Date:
  Thursday, 24 October 2013, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This two-day workshop is a preparatory step to the development of scientific guidance on post-authorisation efficacy studies (PAESs), which the European Medicines Agency will develop according to a mandate set out in the new pharmacovigilance legislation and subsequent to any outputs of the European Commission on the situations in which such studies may be required. The workshop brings together various experts to address five main topics: pragmatic trials; observational studies; registries; the use of electronic health records in pragmatic trials; and methods to control for confounding. Registration by invitation only.

Documents

Highlights from the workshop on methods for efficacy studies in the everyday practice

AdoptedReference Number: EMA/717922/2013 Rev.1

Agenda - Workshop on methods for efficacy studies in everyday medical practice - 24-25 October 2013

Reference Number: EMA/607212/2013