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