HMA/EMA Big Data Stakeholder Forum 2023

• Date:
  Monday, 04 December 2023, 09:30 (CET) - 17:30 (CET)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

As the journey towards data-driven medicines regulation accelerates, the fourth annual Big Data multi-stakeholder forum will take place on 4 December 2023 at the EMA building in Amsterdam (+ enabled virtual participation). It aims to:

•    inspire with opportunities for the future thanks to keynotes speakers;
•    discuss with stakeholders data-enabled opportunities to improve medicines development and the EU;
•    inform and strengthen collaboration with stakeholders and partners on the delivery of the data activities included the Network Strategy to 2025 (fourth update of the Workplan 2023-2025: HMA-EMA joint Big Data Steering Group.
 

Documents

Agenda - HMA/EMA Big Data Stakeholder Forum 2023

Report - HMA/EMA Big Data Stakeholder Forum 2023

Presentation - Session 1 : Report on implementation of the HMA-EMA Big Data Task Force priority recommendations - 4th year into our journey to data driven regulation (P. Arlett, EMA)

Presentation - Session 2 : Changing the discoverability and data quality of EU data ecosystem (S. Perez-Gutthann, ENCePP)

Presentation - Session 2 : Enabling the use and establishing the value of Real-World Evidence – EHDS2 Pilot first insights (D. Umuhire, EMA)

Presentation - Session 2 : How are RWE transforming the EU regulatory network (K. Roes, CBG-MEB)

Presentation - Session 2 : Using RWE. Pilots from DARWIN-EU (W. Goettsch, HTA ZIN)

Presentation - Session 2 : Progress on convergence with international partners on Real World Data (M. Kampman, Health Canada)

Presentation - Session 3 : Realising the potential of PED in EU medicine regulation - BDSG workplan opportunities to enhance use of PED for regulatory decision making (G. Paliouras, NCSR “Demokritos”; DDF)

Presentation - Session 3 : Patient engagement in research area at Barcelona Children’s Hospital (B. Nafria, Saint Joan de Deus Children’s Hospital)

Presentation - Session 3 : The role of healthcare professionals (D. Makridaki, EAHP)

Presentation - Session 3 : Real World Evidence: The PROFILES registry (L. van de Poll-Franse, NCI)

Presentation - Session 3 : Patient Experience Data (PED) - Realising the potential of PED in EU medicine regulation (M. Cavaller Bellaubi, EURORDIS)

Presentation - Session 3 : State of play and ongoing regulatory initiatives (R. Gonzalez-Quevedo, EMA)

Presentation - Session 3 : What is needed by regulators (B. Sepodes, CHMP, INFARMED and S. Straus, PRAC, MEB)

Presentation - Session 4 : Advances in digital technologies to enable collection of Patient Experience Data (J. Isla, DSEF)

Presentation - Session 4 : Quantum computing: a game-changing approach for drug development (A. H. Werner, University of Copenhagen)

Presentation - Session 4 : Regulatory preparedness on Artificial Intelligence: AI workplan (G. Westman, MPA)

Presentation - Session 4 : Use of external data to accelerate evidence generation - digital twins and external controls (H. Fröhlich, Fraunhofer SCAI)

Presentation - Session 5 : Data, not dogma: How data analysis can supercharge evidence-based decision making (A. Aerts, The Novartis Foundation)

Presentation - Session 5 : How data can be used for a better-informed society (S. J. Piatek, LSHTM)

Video recording

Registration

In person and online participation (via Webex) is organised via EU associations and direct invitations to allow a broad range of stakeholders to participate.

The event will also be broadcast live and registration is not required to follow the event online.

Contact point

[e-mail]

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