Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods

• Date:
  Friday, 14 June 2024, 09:00 - 16:30 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands
  Live broadcast

Event summary

This one-day hybrid Big Data Steering Group (BDSG) workshop brings together representatives of regulatory agencies, pharmaceutical companies, patients, healthcare professionals, academia, and health technology assessment bodies to address the following objectives:

• hear the views of stakeholders and experts: 
  • on the draft real-world evidence (RWE) reflection paper, 
  • on priorities for further regulatory guidance development and collaboration beyond the reflection paper;
• engage with stakeholders on RWE methods in regulatory decision making.

Documents

Report - Harnessing Real-world data for regulatory use: Report on the joint HMA/EMA Big Data Steering Group workshop on Real-world evidence (RWE) methods

Agenda - Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods

Presentation - Data-driven approaches in health research & innovation (T.Dyląg, EC)

Presentation - Introduction to regulatory-grade causal inference (X.Garcia de Albeniz, RTI Health Solutions)

Presentation - RWD-derived external controls in regulatory context (E.Asikanius, FIMEA)

Presentation - Use of estimands in target trial emulation (J.Abellan, EMA)

Presentation - The use of RWD derived External Control Arm to assess the Benefit of New Therapies (M.Feudjo Tepie, UCB)

Presentation - Externally controlled trials in oncology (D.Rivera, US FDA)

Presentation - Target trial and estimand in post-market safety studies (R.Izem, Novartis Pharma AG)

Presentation - RWD-derived external controls case study: Abecma (A.Buzzi, T.Framke, EMA)

Presentation - Use of real-world data in non-interventional studies to generate real-world evidence: Draft reflection paper (X.Kurz, EMA)

Presentation - Regulatory perspectives on TTE for pharmacovigilance (R.Fitzgerald, HPRA)

Presentation - Introduction to the Methodology Working Party (K.Roes, EMA)

Presentation - MWP Roadmap for the development of RWE guidance (EMA)

Presentation - The next three years: roadmap for RWE guidance (M.Schoonen)

Presentation - EMA Reflection paper on use of Real-World Data in Non-interventional Studies to Generate Real-World Evidence (A.Spooner, EFPIA)

Presentation - Joint HMA/EMA Big Data Steering Group Workshop on RWE methods Harnessing Real-World Data for Regulatory Use (P.Verpillat, EMA)

Presentation - Target trial emulation in a DARWIN EU vaccine effectiveness study (Dani Prieto-Alhambra, DARWIN EU)

Presentation - Externally controlled trials in oncology (Donna Rivera, FDA)

Video recording