Module 9 2024

03/09/2024

Module 9: Registration of Biological, Biotechnology and Advanced Therapy Products

Module 3 Guidelines and Requirements

Richard Keane, Global Regulatory CMC Pharma, Biogen Idec Ltd.

10 September 2024

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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Learning Outcomes

• Understand at a high level the regulations that apply to CTD Module 3 at the time of licensing for these modalities • Seek to achieve this through generally focussing on the EU and with a direct focus on Module 3

• Present practical examples where these are helpful

The Organisation for Professionals in Regulatory Affairs

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