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