CRED 8 Presentations

01/07/2024

Scientific Advice

National Scientific Advice one or more NCA’s e.g. national SA at the….

Simultaneous national scientific advice (SNSA); EU-Innovation Network (EU-IN)

The Organisation for Professionals in Regulatory Affairs

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Scientific advice: why & when?

• To facilitate the development and availability of high-quality, effective and acceptable safe medicines, for the benefit of patients • In each phase of development (qualificationprocedure, protocol assistance, PRIME (after PRIME has been assigned)) • Scientific content (any module of the dossier or multi-disciplinary = more modules of the dossier) • Advice on significant benefit (e.g. in relation to orphan indications) • Regulatory advice: legal basis and marketing authorisationprocedure

The Organisation for Professionals in Regulatory Affairs

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