Module 9 2021

16/03/2021

Richard Keane Global Regulatory CMC Biogen Idec Ltd

The Organisation for Professionals in 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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