CRED 8 Presentations

01/07/2024

SNSA how does it look like (final report)

The Organisation for Professionals in Regulatory Affairs

11

National Scientific Advice MEB (1/5)

No scientific advice possible during an ongoing procedure!! The MEB has 4 types of scientific advice 1. Simple advice : regulatory advice, advice relating to the pharmaceutical or pre-clinical aspects of the medicinal product, or follow-up advice (general written advice only within 7 weeks after receipt full documentation) 2. Partially multi-disciplinary scientific advice: purely clinical advice regarding the efficacy and safety of a medical product, whether or not in combination with pharmaceutical or pre-clinical, or a combination of pharmaceutical and pre-clinical advice

The Organisation for Professionals in Regulatory Affairs

12