CRED 8 Presentations

01/07/2024

How to make the most of your Authority meetings

Productive meetings • Timely • Well planned • Clear and reasonable objectives • Executed with mutual respect • Minute taking • Followed through

• Preparing for your meetings • Rehearsal • Open consideration of risks and regulatory authority feedback • Who will have authority for decision making? • Consider joint EMA / FDA advice meetings • Consider parallel SWP/HTA Advice when appropriate

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The Organisation for Professionals in Regulatory Affairs

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Pre-submission meetings/Scientific advice

• Centralised • EMA pre-submission meeting – at least 6m prior to filing • (co-)rapporteur meeting(s) • Decentralised/MRP • Establish willingness to act as RMS as part of scientific advice meetings

• Follow-up meeting prior to filing – orientation/update • For MRP – agree extent of the required dossier update

The Organisation for Professionals in Regulatory Affairs

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