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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.

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SESSION 1: INTRODUCTION TO PAS

Session Chair(s)

Michael Busch-Sørensen

Board Member

Danish Society for Pharmacoepidemiology, Denmark

Michael Forstner, PhD, MPH, MSc

Head of Global Safety Science

SOBI, Switzerland

General introduction and practicalities
Relevant PASS legislation
- Directives, regulations and delegated regulations
- Relevant GVP modules
- Templates
- PASS Q&A
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
ICSR/SUSAR reporting requirements according to GVP module VI

Speaker(s)

INTRODUCTION TO PAS

Michael Forstner, PhD, MPH, MSc

SOBI, Switzerland

Head of Global Safety Science

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Post-Authorisation Studies

SESSION 1: INTRODUCTION TO PAS

Session Chair(s)

Michael Busch-Sørensen

Michael Forstner, PhD, MPH, MSc

Speaker(s)

INTRODUCTION TO PAS

Be informed and stay engaged.