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Search results (91)
List of medicines currently in PRIME scheme
English (EN) (120.45 KB - XLSX)
Agenda - European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting
English (EN) (269.41 KB - PDF)
Agenda - DARWIN EU Advisory Board - 11 December 2023
English (EN) (124.37 KB - PDF)
Minutes – DARWIN EU Advisory Board - 24 May 2023
English (EN) (184.19 KB - PDF)
Note on the HORIZON-JU-IHI-2024-06-two-stage funding call: Development of evidence based practical guidance for sponsors on the use of real-world data / real-world evidence
English (EN) (95.91 KB - PDF)
Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 22-25 January 2024
English (EN) (210.4 KB - PDF)
Highlight report of the eleventh meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines
English (EN) (184.44 KB - PDF)
Presentation - Feedback from the latest discussions of the Focus group-agreed actions and next steps (S. Aarum, EMA)
English (EN) (144.43 KB - PDF)
Presentation - the Stepwise Paediatric Investigation Plan (sPIP) (C. Pallidis, EMA)
English (EN) (855.1 KB - PDF)
Presentation - EMA multistakeholder workshop on Qualification of Novel Methodologies (QoNM) – Outcome report and Recommendations (I. Gravanis, and T.Vetter, EMA)
English (EN) (341.7 KB - PDF)