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European Health Technology Assessment

From 2025 onwards, clinical evaluation of medicinal products will take place at European level (from 2025: oncology drugs and ATMPs, from 2028: Orphan drugs, from 2030: any new drug). Ecker + Ecker provides strategic advice and support for all procedural steps including the preparation of the European dossier.

 

Strategy

  • Continuous monitoring of European assessments
  • Support in the planning of studies
  • Lifecycle strategy (post launch evidence generation; PLEG)
  • Cooperation with European partner agencies
  • Support in the coordination of the strategy of individual countries as well as in the development of the overall strategy

 

Joint Clinical Assessment (JCA)

  • Support in the scoping process
  • Medical Writing of the European dossier
  • Parallel coordination and preparation of the German dossier
  • Processing of study results and re-evaluation of studies according to EUnetHTA requirements
  • Calculation of indirect comparisons, (IPD-) meta-analyses and sensitivity analyses
  • Review of the JCA report ("fact check")

 

Joint Scientific Consultations (JSC)

  • Support for JSC and parallel EMA/EUnetHTA JSC
  • Support for national consultations of the European countries
  • Preparation of documents, training, Q&A
  • Follow-up of the JSC, derivation of implications for national HTAs of the European countries and EU HTA

 

Workshops

  • Organizational readiness
  • Feasibility analysis
  • Pipeline check and mock-up
     

European Partner Network

Ecker + Ecker maintains an extensive European partner network where 14 experienced consulting firms are in a regular exchange on EU-HTA. Ecker + Ecker is therefore also a central contact for the different national perspectives regarding market access and EU-HTA. The partner network provides access to 27 European countries.

 

 

 

Das europäische Partnernetzwerk von Ecker + Ecker als Karte

 

Please contact

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Dr. Thomas Ecker
Phone +49 (40) 41 33 081-10