Co-Creating RWE Excellence for Decision-Making: Meeting Regulatory and HTA/Payer Needs

April 22, 2021
16:30 – 18:00 CET
Online

In the first webinar – held on 22 April 2021 – we discussed the implications of the EMA’s Guidelines across the HTA/Payer world on study designs, methodologies and for the future applicability of RWE requirements. Consideration was also given to whether cross-country and cross-stakeholder collaboration should aim to achieve convergence of guidelines, metrics and methodologies for the acceptance of RWE.

Programme

16h30

Welcoming remarks and Opening Statement

Jo De Cock

CEO of RIZIV-INAMI

16h40

Introduction to EMA’s Guideline on registry-based studies, DARWIN and Big Data Stakeholder Implementation Forum

Dr Xavier Kurz

Senior pharmacoepidemiologist and head of data analytics, European Medicines Agency

17h00

Panel interventions from HTA/Payer community

Dr Roisin Adams

Head of HTA Strategy and External Engagement, National Centre for Pharmacoeconomics (NCPE) – Ireland

Dr Antje Behring

Acting Head of Drug Department, Federal Joint Committee (G-BA) – Germany

Dr Pier Paolo Olimpieri

Data Analyst Coordinator, Monitoring Registries Office, Italian Medicines Agency (AIFA) – Italy

Piia Rannanheimo

Pharmacoeconomist, Finnish Medicines Agency (FIMEA) – Finland

Prof Cláudia  Furtado

Head of Health Technology Assessment, Pricing and Reimbursement Division (DATS) and the Information and Strategic Planning Division (INFARMED) – Portugal

17h30

Panel discussion and Q&A with the audience

17h55

Closing remarks

Jo De Cock

CEO of RIZIV-INAMI

18h00

Meeting close

Background

In the spirit of a ‘Learning Network’, RWE4Decisions is hosting a series of three webinars to exchange experiences on existing guidance and initiatives seeking to ensure robustness of Real-World Evidence (RWE). The objective is to enable an open exchange and foster mutual learnings to identify current barriers, enablers and possible collaborative opportunities to enhance efficiencies and provide useful guidance to create a harmonised approach to RWE generation that strengthens trust in the use of real-world evidence for decision-making.

Other past events

Public Webinar: From Policy to Practice: EHDS Implementation to Support Better Real-World Evidence for HTA/Payers

April 9, 2025
15:00-16:30 CEST
Online

RWE4Decisions Symposium: Developing Real-World Evidence to Deliver Innovation in HTA

November 14, 2024
09:00-13:00 CET
Hybrid

Public Webinar: HTA/Payer Collaboration in the Nordics: The Role of Real-World Evidence

October 23, 2024
15:00-16:00 CEST
Online