4th Meeting of the STAMP Expert Group

10 March 2016

• Agenda.
• Presentations and background documents (following the Agenda points):
  • 3 - Repurposing of established medicines/active substances
    • Background paper and presentation by the UK Medicines and Healthcare products Regulatory Agency.
  • 4 - Real world evidence data collection
    • Background paper and presentation by the European Medicines Agency (EMA).
    • Member State experience presentation by the Italian Medicines Agency (AIFA).
  • 5 - Update on European Medicines Agency activities
    • a. Adaptive Pathways
      • Replies from Member States to the questionnaire on adaptive pathway pilot project and presentation by EMA.
      • The Presidency meeting on "Adaptive pathways / early access schemes" - presentation by the Netherlands Ministry of Health, Welfare and Sport.
    • b. PRIority MEdicines (PRIME) Scheme, CHMP scientific guidance on Conditional marketing authorisations, CHMP scientific guidance on Accelerated assessment update by EMA.
  • 6 - Compassionate use programmes
    • Background paper on compassionate use and presentation of the experience of Article 83 compassionate use opinions at EMA.
    • Industry experience of compassionate use opinions – presentation by the European Federation of Pharmaceutical Industries and Associations (EFPIA).
  • 7 - Personalised medicines
    • Commission funded research initiatives presentation by DG Research and Innovation.
    • Background paper and presentation by DG Health and Food Safety.
• Record.