CRED Successful and Skilful Communications 2025

Considerations • organisation’s internal expertise, opinion leaders, regulatory consultants, advisory boards • Regulators’ expertise • Experience with other products: minutes from scientific advices, lists of questions, recent approvals, refusals • Existing (e.g. recently approved) EPARs for similar products • Status of development • Geographical aspects • Existing EU, ICH (draft) guidelines • Risk of being told “something you don’t want to hear”! Do you need to meet regulators face-to face?

The Organisation for Professionals in Regulatory Affairs

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3. How to Prepare for Best Outcomes From an Interaction

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The Organisation for Professionals in Regulatory Affairs

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