CRED Successful and Skilful Communications 2025

Why interactions with your regulators?

Build and maintain relationship with your ‘key customer’ • Establish trust – be truthful and objective • Establish early dialogue if possible • not too early, plan first • do not wait until there are issues or the issues worsen • Anticipate issues and jointly resolve problems, before they become serious • Share the logic of regulatory strategy and if relevant, development plan • Communicate new data • Monitor changes in regulator’s attitude or expectations of data

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The Organisation for Professionals in Regulatory Affairs

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General scientific advice can be obtained for …

• Questions relating to the interpretation and implementation of (draft) guidelines, (draft) pharmacopoeial monographs • Emerging and new therapies • Evidence to support a product claim • Product classification (e.g. device vs medicine) • On methodological questions, e.g. release testing, bioquivalence

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The Organisation for Professionals in Regulatory Affairs

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