webinar

Update: Post Authorization Safety Studies landscape, the 2010 EU PV Legislation and impact on today’s observational post-marketing studies

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May 18, 2016

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Since the introduction of the 2010 European Pharmacovigilance legislation, a broad spectrum of public available data on Post Authorisation Safety Studies (PASS) have emerged including information on study regulatory, methodological and operational considerations. Please join us in a complimentary webinar that aims to review scientific and practical insights on PASS landscape during the first three complete years of the legislation and to provide the latest perspectives in observational post-marketing studies. 

This webinar will be presented by Priscilla Velentgas, Senior Director, Epidemiology at Quintiles Real World & Late Phase Research, and Pierre Engel, PharmD, MPH, PhD, Director of Epidemiology at Quintiles Real World & Late Phase Research and member of the Steering Group of the European Network of Pharmacovigilance (ENCePP). Ms. Velentgas and Dr. Engel will highlight: 

  • Understanding European Medical Agency's(EMA) Post Authorization Safety Studies (PASS)
  • Practical review and application of the EU legislation and regulations, impacting the conduct of post-marketing safety studies.
  • Lessons learned on the design and the conduct of observational post-marketing safety studies.
  • Perspectives and latest trends in regulatory required post-marketing studies: Post Authorization Efficacy Studies (PAES), meeting both European Medical Agency(EMA) and Food and Drug Administration (FDA) requirements.