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.

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SESSION 2: DETAILS ON EU GUIDELINES

Session Chair(s)

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)

DETAILS ON EU GUIDELINES

Gro Laier, MD

Denmark

PV Expert

Post-Authorisation Studies (PAS)

SESSION 2: DETAILS ON EU GUIDELINES

Session Chair(s)

Gro Laier, MD

Speaker(s)

DETAILS ON EU GUIDELINES

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