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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 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

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Post-Authorisation Studies

SESSION 2: EU GUIDELINES/REGULATION – ONGOING CHANGE

Session Chair(s)

Michael Busch-Sørensen

Speaker(s)

EU GUIDELINES/REGULATION – ONGOING CHANGE

Be informed and stay engaged.