(0)

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

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.

Back to Agenda

SESSION 2: DETAILS ON EU GUIDELINES

Session Chair(s)

Gro Laier, MD

Gro Laier, MD

PV Expert

Denmark

  • Relevant legislation for the distinction between PAS and pragmatic Clinical Trials
  • The link between Risk Management, risk minimization and PASS
  • How to handle imposed and non-imposed PAS (PASS & PAES) studies i.e. rules for reporting of milestones, amendments and safety data.
  • PAES legislation and guideline
  • ICSR/SUSAR reporting requirements according to GVP module VI

Speaker(s)

Gro Laier, MD

DETAILS ON EU GUIDELINES

Gro Laier, MD

Denmark

PV Expert

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.