CRED 8 Presentations

01/07/2024

MEB’s scientific advice procedures:  Scientific advice can never be a substitute for an application for marketing authorisation and the advice provided has no bearing on the final assessment of the MEB and/or the CHMP. The MEB will not carry out a (preliminary) assessment of results or data outside the context of the dossier as a whole or attach any conclusion to it. The MEB will not make a decision on the benefit-risk balance!  MEB is also participating in pilot for Simultaneous National Scientific Advice (SNSA) For more information/application form/fees: See MEB website: https://english.cbg-meb.nl/topics/mah-scientific-and-regulatory-advice National Scientific Advice MEB (5/5)

The Organisation for Professionals in Regulatory Affairs

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Formulating questions • Is the answer already available in guidance? Do you want to deviate? Maximise effectiveness of advice

• Briefing documents: beconcise – Not too little – to allow informed decisions – Not toomuch –to allow proper review

• No pre-evaluation  If we perform this set of (non)clinical studies, would that be sufficient to start a phase III clinical study? X We have performed the following (non)clinical studies, are the results a sufficient justification for starting a phase III study with a dose of X mg/kg?

The Organisation for Professionals in Regulatory Affairs

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