1st Meeting of the STAMP Expert Group

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:
    • Presentation by the Federal Agency for Medicines and Health products-Belgium.
    • Presentation by the Ministry of Health France.
    • Presentation by the Spanish Agency of Medicines and Medical Devices.
  • 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.