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

Apr 29, 2023 •180 likes •233 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

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 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 2
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 3
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? 4

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