CRED 8 Presentations

01/07/2024

New MAA’s in the Centralised Procedure Theory vs Reality 12-13 March 2020

Paul Nitschmann, Intercept Pharmaceuticals

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals in Regulatory Affairs

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Learning Outcomes

 Respect the process and respect the people ● you will find room to do what is right for the patient  Think strategically / think globally  Manage internal expectations  What are the potential outcomes at D181?  Impact of PRAC, CAT, SAWP, and other WPs, ODD

The Organisation for Professionals in Regulatory Affairs

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