Public w orkshop Best expertise vs conflicts of interests: Striking - - PowerPoint PPT Presentation

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Public w orkshop Best expertise vs conflicts of interests: Striking - - PowerPoint PPT Presentation

Apr 29, 2023 180 likes •238 views

Public w orkshop Best expertise vs conflicts of interests: Striking the right balance PDCO Experience Daniel Brasseur, Chair PDCO, European Medicines Agency, EU 6 September 2013 An agency of the European Union CoI Peter Principle ? A

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An agency of the European Union

Daniel Brasseur, Chair PDCO, European Medicines Agency, EU

6 September 2013

Public w orkshop Best expertise vs conflicts of interests: Striking the right balance PDCO Experience

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CoI « Peter Principle ? »

A bottom up scientific construct (product - researcher/ conceptor Market? SA (trial - investigator/ patients SA,NCA (file - industry/ experts (PDCO,COMP,… ) (dossier - (national) assessors NCA (opinion- regulator CHMP, PRAC (decision- administration EMA/ EU

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CoI « Peter Principle ? »

A top down consultation process EU ? With decision go to Pharma Committee EMA ? With opinion go to CHMP, PRAC… CHMP ? With dossier go to WP or SAG PDCO ? With PIP go to FWG, NCWG or WP Industry ? With PDCO go to SA All (guidance) ? Go to external consultation

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CoI « Peter Principle ? »

Back to A bottom up decision making process (assesment - rapporteur NCA (final opinion - CHMP (PDCO) (administration - EMA (opinion - EU The closer to the decision the farer from the user CoCompetence?

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