CRED Successful and Skilful Communications 2025

Recap: General scientific or procedural advice can be obtained for …

• Questions relating to the interpretation and implementation of (draft) guidelines, (draft) pharmacopoeia monographs • Emerging and new medical therapies • Evidence to support product claim(s) • Product classification (e.g. MD vs medicine) • Legal basis for proposed MAA • On methodological questions (e.g. release testing, bioquivalence)

The Organisation for Professionals in Regulatory Affairs

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Recap: Product specific scientific advice can be obtained for …

• Environmental risk • Use of ingredients • Advertising copy • Development strategy to optimise drug development • Quality Target Product Profile (QTPP) • Clinical protocol assessment • Clinical programme design • Extension of indication • PIPs • Post-authorisation / FUM*s / PSURs / line extensions

* Follow-up Measures

The Organisation for Professionals in Regulatory Affairs

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