This event has ended.
- medicinal product
- Tuesday 20 October 2015, 04:00 (CEST)
Practical information
- When
- Tuesday 20 October 2015, 04:00 (CEST)
- Languages
- English
Report
20 October 2015
- Agenda.
- Presentations and background documents (following the Agenda points):
- 3 - Regulatory tools for early access:
- a. Conditional marketing authorisations (CMA)
- b. Accelerated assessment and PRIME scheme
- Revised CHMP guidelines and summary of comments received during public consultation.
- PRIME New scheme to support development of innovative medicines for unmet needs. Background document for discussion.
Public consultation started on 26 October with the deadline for comments 23 December 2015. Further information can be found on EMA website.
- c. Adaptive Pathways
- Comprehensive discussion on policy related issues on the basis of current experience from the EMA's pilot project.
- "Prescrire" presentation and position paper on adaptive pathways.
- d. Cross-cutting issues for all tools
- 4 - Update on other EU initiatives relevant for timely patient access to innovative medicines
- 3 - Regulatory tools for early access:
- Record.