The main objective of Work Package 5 is to help generate, all along the technology life cycle, optimal and robust evidence for health technologies (pharmaceuticals or others), bringing benefits for patient access and public health.
This Work Package consists of two strands:
Work Package 5A
AEMPS, AETS-ISCIII, AETSA, Agenas, AIFA, AOTMiT, AQuAS, AVALIA-T, GBA, HAS, Hdir, HVB, INFARMED, IQWIG, JAZMP, KCE, MoH Cyprus, MPA, NCPHA, NICE, NIPN, NOMA, NSPHMPDB, Osteba, RER, RIZIV-INAMI, SNHTA, TLV, Veneto/CRUF, ZIN
Composition of the Early Dialogues Working Party (EDWP): France (HAS), Germany (GBA), United Kingdom (NICE), Italy (Italian Medicines Agency: AIFA with alternate Regione Emilia-Romagna: RER), Hungary (National Institute of Pharmacy and Nutrition: NIPN), and a shared seat for The Netherlands/ Belgium (Zorginstituut Nederland: ZIN/ Rijksinstituut voor Ziekte- en Invaliditeitsverzekering/ Institut national d’assurance maladie-invalidité: RIZIV-INAMI)
Work Package 5B
AETSA, Agenas, AIFA, AQuAS, AVALIA-T, CIPH/HZJZ, DGFDM IT, EKAPTY SA, FIMEA, HAS, Hdir, INFARMED, IPH, JAZMP, MPA, NICE, NIJZ, NOMA, Osteba, RER, SNHTA, UCSC GEMELLI, UniBA FOF, UTA, Veneto/CRUF, ZIN
Deliverables from Strand A – Early Dialogues (ED):
Develop and implement a financially sustainable system for delivering EDs.
Deliverables for Strand B – Post-Launch Evidence Generation (PLEG) and Registries:
French National Authority for Health (Haute Autorité de Santé)
5, avenue du Stade de France
F-93218 Saint-Denis La Plaine Cedex
AEMPS, AETS-ISCIII, AETSA, Agenas, AIFA, AOTMiT, AQuAS, AVALIA FNS, AVALIA-T, CIPH, DGFDM IT, EKAPTY SA, FIMEA, Hdir, HVB, INFARMED, IPH, IQWIG, JAZMP, KCE, MoH Cyprus, MPA, NCPHA, NICE, NIJZ, NIPN, NOMA, NSPHMPDB, Osteba, RER, RIZIV-INAMI, THL, TLV, UCSC GEMELLI, UniBA FOF, UTA, Veneto/CRUF, ZIN
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