European Medicines Agency and European Union payer community meeting

• Date:
  kedd, 18 június 2019, Egész nap
• Helyszín:
  European Medicines Agency, Amsterdam, the Netherlands

EMA and EU healthcare payers meet for a second time to explore synergies and foster mutual understanding and cooperation to help improve timely and affordable access of patients to new medicinal products.

This complements EMA’s existing cooperation with Health technology assessment bodies and especially with EUnetHTA.

Documents

Minutes of the European Medicines Agency and European Union payer community meeting

Agenda - European Medicines Agency and European Union payer community meeting

Presentation - Prospective planning of evidence generation for orphan medicinal products - Opportunities for multi-stakeholder dialogue (payers' perspective) (E.Van Lente)

Presentation - Prospective planning of evidence generation for orphan medicinal products - Opportunities for multi-stakeholder dialogue and MoCA (S.Boselli)

Presentation - Prospective planning of evidence generation for orphan medicinal products - Opportunities for multi-stakeholder dialogue and MoCA (company perspective) (W.Hughes-Wilson)

Presentation - Defining unmet medical need (J.Stokx)

Presentation - Unmet medical need: an introduction to definitions and stakeholder perceptions (J.Llinares Garcia)

Presentation - Draft reflection paper on the wording of therapeutic indication (M.Ermisch)

Presentation - Wording of indication, labelling and assessment report (H.Hillege, K.Dunder)

Presentation - Indication and Labelling (J.Llinares Garcia)

Presentation - International Horizon Scanning Initiative (E.Klein Lankhorst)

Presentation - Follow-up discussion on Horizon Scanning activities (M.Berntgen, EMA)

Presentation - CAR-T RWD DLBCL: A case study on the use of Real World Data (L.Timmers)

Presentation - Post licensing evidence generation through reimbursement data (D.Lingri)

Presentation - Regulatory Perspective on Post-licensing Evidence Generation (PLEG) Qualification of EBMT registry for post-licencing evidence generation for CAR-T cells authorised for haematological malignancies (S.Vamvakas, EMA)

Presentation - Post-licensing evidence in medicines regulation (X.Kurz, EMA)