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 1: INTRODUCTION TO PAS

Session Chair(s)

Gro Laier, MD

PV Expert

Denmark

General introduction and practicalities
Relevant PASS legislation

Directives, regulations and delegated regulations
Relevant GVP modules
Templates
PASS Q&A

Speaker(s)

INTRODUCTION TO PAS

Gro Laier, MD

Denmark

PV Expert

Post-Authorisation Studies (PAS)

SESSION 1: INTRODUCTION TO PAS

Session Chair(s)

Gro Laier, MD

Speaker(s)

INTRODUCTION TO PAS

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