Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Holiday Inn London Kensington Forum

Feb 21, 2017 8:00 AM - Feb 22, 2017 12:00 PM

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 Von Forstner, PhD, MPH, MSc

Michael Von 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

Board Member, Danish Society for Pharmacoepidemiology, Denmark

Michael Von Forstner, PhD, MPH, MSc

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

Michael Von Forstner, PhD, MPH, MSc

Managing Director, Head of Pharmacoepidemiology Practice, Mesa Laubela Consulting, Switzerland

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.