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Clinical Trial Events
DIA Europe

Talk Data Science, RWE & Artificial Intelligence track

S0304 - Clinical Evidence Generation In Action

Wed, Mar 19, 2025 · 10:30–11:40 AM CET Montreal Room, Congress Center Basel

About this session

How can real-world data (RWD) revolutionize evidence generation in healthcare? This session will focus on practical methods for gathering and utilizing RWD to drive impactful outcomes. Attendees will explore case studies that illustrate the transition from theoretical discussions to real-world applications. Topics include enabling randomized pragmatic studies with new technologies, leveraging RWD for predictive treatment modeling in personalized medicine, and strategic involvement of women of childbearing age (WoCBA) in clinical trials. The session will also cover pre- and post-approval approaches for using real-world evidence in regulatory decision-making, highlighting the tangible benefits for patient health and safety.

Programme:
- 3. Enabling randomized pragmatic studies through the use of RWD sources and new technologies — Nafsika Kronidou
- 7. Panel Discussion — Karl Broich, François Houyez
- 4. Leveraging RWD for Enhanced Predictive Treatment Effect Modelling in Personalized Medicine — Francesca Frau
- 5. From an RWE driven approach to strategic involvement of WoCBA in clinical trials — Muriel Pasté
- 1. Setting the scene — Patrice Verpillat, Karl Broich
- 6. Real-world evidence for regulatory decision-making: pre and post approval approaches — Sara Escola
- 2. Session Structure — Gracy Crane

Speakers

  • Patrice Verpillat

    Head of Real World Evidence · European Medicines Agency

    Chair

  • Gracy Crane

    Policy Lead · Roche

    Chair

  • Muriel Pasté

    Head of EU Regulatory Affairs · UCB

    Speaker

  • Francesca Frau

    Development Real World Evidence Lead · Sanofi

    Speaker

  • Karl Broich

    President · Federal Institute for Drugs and Medical Devices (BfArM)

    Speaker

  • François Houÿez

    Treatment Information and Access Director, Health Policy Advisor · European Organisation for Rare Diseases (EURORDIS)

    Panelist

  • Nafsika Kronidou

    Regulatory Portfolio Strategy Lead · Roche

    Speaker

  • Sara Escola

    Regulatory Affairs Senior Manager · PTC Therapeutics

    Speaker