CRED 8 Presentations

01/07/2024

CRED Navigating European Regulatory Procedures – 9-10 July 2024 Overview of the European Regulations

Kora Doorduyn-van der Stoep; EU-representative at the MEB Medicines Evaluation Board / NL

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

 A brief outline of the Centralised and Mutual Recognition /Decentralised procedures  The role of the regulatory bodies, i.e. EMA, CHMP, COMP, PDCO, SAGs, EU Commission, CMDh, National Authorities, ATMP, PRAC, EMA-re-structure (new tasks)  Update to ongoing pharmaceutical legislation  Orphan Drug Regulations  Paediatric Regulations  PRIME and similar initiatives  Considerations for SMEs  The role of patients

The Organisation for Professionals in Regulatory Affairs

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