This event has ended.
- medicinal product
- Tuesday 27 January 2015, 02:00 (CET)
Practical information
- When
- Tuesday 27 January 2015, 02:00 (CET)
- Languages
- English
Report
27 January 2015
- Agenda.
- Presentations (following the Agenda points):
- 2. Scope and operation of the STAMP.
- 4. Exchange of experiences from national routes (other than clinical trials) for making available medicines to patients before authorisation:
- 5. EMA's pilot project on Adaptive Licensing.
- 6. Regulatory tools for early access
- a. Results from the Escher project 'Improving the EU system for the marketing authorisation of medicines'.
- b. FDA Breakthrough therapy designation program.
- c. Experience with conditional marketing authorisations (CMA).
- d. Member States' experience on results from the use of early access tools (conditional marketing authorisation, authorisation under exceptional circumstances, accelerated assessment).
- Record.