03 December Pipeline meeting 3 December 2024
Activities data
- MEB
A pipeline meeting is a session where the MEB engages with a company to discuss new innovations and plans in the area of drug development for the upcoming period. The primary focus is on the general aspects of the company's product portfolio.
Next Meeting: Tuesday, December 3, 2024; CCMO present.
Topic: Potential use of Real-World Data (RWD) complementing trial data to support the benefit/risk of a medicinal product
Applicants can apply for this pipeline-day with new innovative developments related to:
Evidence derived from Real World Data (RWD) / Real World Evidence (RWE) to support regulatory decision-making:
- Pre/peri-approval; e.g., as external control, as natural history, or to complement control arms
- Post-approval; e.g., to confirm or complement long-term clinical benefit of products (conditionally) approved based on surrogate endpoints , or to understand drug effects (effect modification) in important subgroups
RWD sources, specifically patient registries, intended to be used to support regulatory decision-making
The applicant is informed that no scientific advice will be provided during pipeline-meetings and the discussion will focus on innovative developments in the portfolio of the company.
Registration Deadline: Friday, September 27, 2024.
After the registration deadline, the MEB will select three companies from the submissions. The selected companies will be informed via email about their scheduled pipeline meeting. Companies that are not selected will receive a rejection notice via email. Notifications can be expected on Monday, October 14, 2024.
If a pharmaceutical company is selected to participate in a specific Pipeline Day, we ask the company to provide a briefing document to help the MEB participants prepare for the meeting. This briefing document should be submitted no later than Friday, November 15, 2024. A link to the briefing document will soon be published on this website.