CRED Successful and Skilful Communications 2025

• The European Medicines Agency • The Biocidal Products Committee/ European Chemicals Agency • National Competent Authorities (AIFA, BfArM, DIKLZ, FAMHP, HPRA, MHRA, AEMPS) • Notified Bodies (BSI, LRQA, NSAI, SGS Belgium, TÜV NORD) • Trade Associations: ● Biocides: EFTA, ● Cosmetics: Cosmetics Europe, CTPA ● Medicines: EFPIA, Medicines for Europe, Europabio ● Medical Devices, ABHI, BIVDA, BVMed, EMIG, Eucomed, MedTech Europe Who are the external “regulators/ gate-keepers”?

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The Organisation for Professionals in Regulatory Affairs

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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 • Extension of indication • PIPs • Post-authorisation / FUM*s / PSURs / line extensions

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The Organisation for Professionals in Regulatory Affairs

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