The objective of this meeting is to discuss the significance of real-world evidence in the (benefit) assessment of gene therapies and the connection with innovative reimbursement schemes. It will focus on identifying potential similarities with the marketing authorisation process of the European Medicines Agency (EMA) to initiate early on long-term cooperation between EMA and the health technology assessment (HTA) institutions with regard to data requirements.

Organiser: Federal Ministry of Health

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Bundesinstitut für Arzneimittel und Medizinprodukte

Fachgebiet Internationaler Austausch und Konferenzen

+49 228 99307 3183