CRED 8 Presentations

01/07/2024

The Centralised Procedure – The Details

Alex Yates VP Regulatory Affairs, BicycleTx Limited 10 July 2024

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

 Preparing for and applying for a CP (including eCTD compilation)  Managing the procedure  Interacting with the EMA/(co-)rapporteur/PRAC  The role of the CHMP  The Commission decision making process  Re-examination of an Opinion  Organisingyour company  Common problems and pitfalls

The Organisation for Professionals in Regulatory Affairs

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