CRED 8 Presentations

01/07/2024

National Scientific Advice MEB (2/5)

MEB’s scientific advice cont’d 3. Fully multi-disciplinary advice: advice relating to the clinical, pre clinical and pharmaceutical aspects of the medicine.

4. Customised advice (‘Advies op Maat’) – Start-ups, small companies and academic groups – Focus on early phase of development – Regulatory roadmap – Reduced tariff

The Organisation for Professionals in Regulatory Affairs

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National Scientific Advice MEB (4/5)

MEB’s scientific advice procedures 1. Written advice only (general within7 weeks after submissionof full documentation/validation) 2. Meeting (between 6 weeks to 3 months after request for advice has been validated) followed by written advice 3. Joint advice from the MEB and the National Health Care Institute (NHCI) (reimbursement) *at the moment not possible - For NHCI there is a focus on phase 3 clinical trials: comparator, endpoints NB: MEB cannot provide advice on FIH (first in human) studies, as not in remit of MEB. However MEB prepared think about dvelopment dossier for studies in later phase

The Organisation for Professionals in Regulatory Affairs

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