Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use

• Date:
  Monday, 26 June 2023, All day
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

Building upon the experience of the submission of real-world evidence for regulatory purpose and the conclusions of previous activities around data standardisation, metadata, data quality and DARWIN EU®, this workshop aims to:

• Discuss important challenges related to measuring and characterising data quality in the context of RWE generation.
• Familiarise stakeholders with the approach used in drafting of considerations on Real-World Data linked to the EU Data Quality Framework.
• Discuss recent use of RWE in the regulatory context and share lessons learned.
• Look back at the European Medicines Regulatory Network response to the COVID-19 pandemic and reflect on learnings and impact on the way we use RWE to address public health emergencies.
• Collect input from experts in the field and learn from existing experiences.
• Get multi-stakeholders’ input to identify ways to enable further use and continue to establish the value of RWE in regulatory processes.

Video recording

Documents

Agenda - Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use

Report - Multi-stakeholder workshop on Real World Data (RWD) quality and Real World Evidence (RWE) use

Reference Number: EMA/EMA/392935/2023

Presentation - The EU Pharmaceutical Reform (S. Rafael Almeida, DG SANTE)

Presentation - TEHDAS Data Quality Framework: Excellence in data quality (E. Bernal Delgado, TEHDAS)

Presentation - EU Data Quality Framework and development of the RWD deep dive (A. Cochino, EMA)

Presentation - RWD Data Quality Experience in Finland (P. Rannanheimo, FIMEA)

Presentation - Real World Data (RWD) quality and experience Danish national health registers (S. Knudstrup, K. Holt Nielsen, Danish Health Data Authority)

Presentation - RWD Data Quality Experience in France (E. Bacry, Health Data Hub)

Presentation – RWD Data Quality Experience by Industry (K.H. Zou, Viatris)

Presentation - Systems and processes underpinning Real-World Data : Characterisation and maturity model consideration (A. Cochino, EMA)

Presentation - Data quality metrics in the context of DARWIN EU (M. Moinat, DARWIN EU Coordinating Centre)

Presentation - Data Quality metrics for Real-World Data (K.Deli, EMA)

Presentation - Data quality requirements and study design and analysis aspects (O. Klungel, Utrecht University)

Presentation - Data quality in fit for purpose assessments (J. Abellan, EMA)

Presentation - A report on the experience with regulatory led RWD studies (S. Prilla, EMA)

Presentation - Use of RWE in medicines development and regulatory submissions - an industry perspective (A. Spooner, AbbVie)

Presentation - Use of RWE in medicines development and regulatory submissions - a regulator’s perspective (C. Torre, University of Lisbon)

Presentation - Survey results : Use (-fulness) of RWE in regulatory decisions (S. Prilla, EMA)

Presentation - DARWIN EU: where we are in the Phase 2 of its implementation (A. Segec, EMA)

Presentation - DARWIN EU to support HTA and payers’ research RWE needs (J. Abellan, EMA)

Presentation - DARWIN EU to support EHDS2 pilot (M. Jendrossek, EHDS)

Presentation - DARWIN EU in the context of infectious diseases and health emergencies (E. Duffell, ECDC)

Presentation - Patient registries in regulatory decision making : Regulator’s vision and experiences (P. McGettigan, PRAC)

Presentation - Assessing the EMA data quality framework (DQF) dimensions using REQUeST: a decentralized registry use case (P. Dobay, Meritxell Sabidó)

Presentation - Registry based randomized clinical trials (R-RCT) - from SWEDEHEART to EuroHeart (L. Wallentin, Uppsala University)

Presentation - Survey results on the EMA guideline on registry based studies (K. Plueschke, EMA)

Presentation - Patient representative perspective - panel discussion (M. De Lemus, CAT)

Presentation - Measuring vaccine performance under emergency situations - case studies and learnings for RWE generation (M. Goossens, EMA)