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Holiday Inn London Kensington Forum

2017年2月21日 (火) 午前 8:00 - 2017年2月22日 (水) 午後 12:00

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

Post-Authorisation Studies

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-EU GVP GUIDELINES, GVP RELEVANT GUIDANCES, DATA SOURCES ETC.

Session Chair(s)

Michael  Busch-Sørensen

Michael Busch-Sørensen

Board Member

Danish Society for Pharmacoepidemiology, Denmark

Michael  Forstner, PHD, MPH, MSC

Michael Forstner, PHD, MPH, MSC

Managing Director, Head of Pharmacoepidemiology Practice

Mesa Laubela-Consulting, Switzerland

  • Revision GCP data privacy prospective vs secondary data
  • Implementation of GVP outside EU
  • ISPE guidances (GPP, Ethics, Privacy, contracts etc.)
  • ENCePP & EU PAS Registry
  • CONSORT & study check list

Speaker(s)

Michael  Busch-Sørensen

NON-EU GVP GUIDELINES, GVP RELEVANT GUIDANCES, DATA SOURCES ETC.

Michael Busch-Sørensen

Danish Society for Pharmacoepidemiology, Denmark

Board Member

Michael  Forstner, PHD, MPH, MSC

NON-EU GVP GUIDELINES, GVP RELEVANT GUIDANCES, DATA SOURCES ETC.

Michael Forstner, PHD, MPH, MSC

Mesa Laubela-Consulting, Switzerland

Managing Director, Head of Pharmacoepidemiology Practice

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