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Paediatric Committee (PDCO) – Meeting Minutes 16-19 May 2017

The minutes include the following topics: Opinions (on products, on Compliance Check, on Modification of an Agreed Paediatric Investigation Plan, on Re-examinations), Discussion of applications, Nominations, Scientific Advice Working Party and Paediatric Committee Interaction, Discussion of the applicability of class waivers, Discussion on the inclusion of an indication within an agreed PIP/waiver, Annual reports on deferrals, and Organisational, regulatory and methodological matters.


#Clinical #Pharmacovigilance

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