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Holiday Inn London Kensington Forum

Jun 13, 2016 8:00 AM - Jun 14, 2016 12:00 PM

97 Cromwell Road, London, SW7 4DN, United Kingdom

Post-Authorisation Studies (PAS)

This course offers insight into EU legislation on PASS and PAES. Examples of PAS protocols as well as some examples of classic pitfalls in study conduct will be presented and discussed.

SESSION 5: NON-GVP GUIDELINES

Session Chair(s)

Michael  Forstner, PhD, MPH, MSc

Michael Forstner, PhD, MPH, MSc

Managing Director, Head of Pharmacoepidemiology Practice

Mesa Laubela-Consulting, Switzerland

  • Presentation of the EU PAS registry
  • Can data on CTs be found public? Clinicaltrials.gov – a presentation
  • ENCePP guide in details
  • ISPE GPP guide in details
  • Specific EMA guidelines

Speaker(s)

Michael  Forstner, PhD, MPH, MSc

NON-GVP GUIDELINES

Michael Forstner, PhD, MPH, MSc

Mesa Laubela-Consulting, Switzerland

Managing Director, Head of Pharmacoepidemiology Practice

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