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

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.

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.


16h30 – Jo De Cock, CEO of RIZIV-INAMI, Welcoming remarks & Opening Statement 
16h40 – Dr Xavier Kurz, Senior pharmacoepidemiologist and head of data analytics, European Medicines Agency – Introduction to EMA’s Guideline on registry-based studies, DARWIN and Big Data Stakeholder Implementation Forum 
17h00 – Panel interventions from HTA/Payer community
Moderated by Dr Karen Facey, University of Edinburgh and consultant to RIZIV-INAMI

  • 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 remarksJo De Cock, CEO of RIZIV-INAMI
18h00 – Meeting close