CRED ERP 25

01/07/2025

The Centralised Procedure – The Details

Alex Yates

VP Regulatory Affairs & Development Quality, BicycleTx Limited

9 July 2025

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 • Organising your company • Common problems and pitfalls The views and opinions included in this presentation are my own, and do not necessarily represent the views or opinions of Bicycle Therapeutics

The Organisation for Professionals in Regulatory Affairs

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