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SESSION 2: EU GUIDELINES/REGULATION – ONGOING CHANGE
Session Chair(s)
Michael Busch-Sørensen
Board Member
Danish Society for Pharmacoepidemiology, Denmark
- Clinical Studies (Study types, Risk based approach, Data privacy & verification/validation)
- Benefit/risk post approval: GVP (PAS & Registries) & Adaptive licensing
- PAES Scientific guidance
- Pragmatic compliance with protocols, submissions, reporting etc.
Speaker(s)
EU GUIDELINES/REGULATION – ONGOING CHANGE
Michael Busch-Sørensen
Danish Society for Pharmacoepidemiology, Denmark
Board Member