2nd Meeting of the STAMP Expert Group

6 May 2015

• Agenda.
• Presentations (following the Agenda points):
  • 3 - Regulatory tools for early access:
    • 3 a - CHMP Reflections on the experience with Conditional Marketing Authorisation.
    • 3 a - Conditional marketing authorisations (CMA).
    • 3 b - Regulatory tools for early access: Accelerated assessment procedure.
    • 3 c - Update on adaptive pathways pilot project.
  • 4 - Update on other EU initiatives relevant for timely patient access to innovative medicines:
    • 4 a - EU cooperation on HTA – latest developments.
    • 4 a - European network for Health Technology Assessment.
    • 4 b - The Network of Competent Authorities on Pricing and Reimbursement (CAPR).
  • 5 - Exchange of experiences from national routes (other than clinical trials) for making available medicines to patients before authorisation: early access schemes, compassionate use etc.
    • The UK Early Access to Medicines Scheme - Presentation by the Medicines and Healthcare products Regulatory Agency (MHRA).
  • 6 - Introduction of Ministry of Health Labour and Welfare of Japan(MHLW)/Pharmaceuticals and Medical Devices Agency (PMDA) and recent updates in Japan
    • Presentation.
• Record.