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Clinical Trial Events
DIA Europe

Talk Regulatory Operations track

S0803 - Transforming Regulatory Landscapes: Driving Regulatory Innovation via AI/Automation, Data Exchange and Harmonisation

Wed, Mar 19, 2025 · 3:00–4:10 PM CET Boston 1-2 Room, Congress Center Basel

About this session

This session will provide insights from international health authorities and Industry to illustrate the benefits of a secure, open-source, regulatory cloud environment with findings from international regulatory collaboration use cases. It will explore how cloud-based solutions can facilitate streamlined regulatory processes, enhance data sharing and collaboration, and support the digital transformation of the pharmaceutical sector. Global regulators, industry leaders, and technology experts will discuss the benefits, challenges, and future potential of cloud technology in advancing regulatory harmonisation and industry digitalisation.

Programme:
- 1. Global Synergy: Advancing Harmonisation and Reliance through Regulatory Cloud Collaboration — Vada Perkins
- Panel Discussion — Claire Harrison, Vada Perkins, Faizan Rahim, Steve Gens, Dominique Lagrave, Magdalena Bujar
- 0. Introduction — Vada Perkins

Speakers

  • Magdalena Bujar

    Associate Director · Centre for Innovation in Regulatory Science (CIRS)

    Panelist

  • Claire Harrison

    Chief Digital and Technology Officer · Medicines and Healthcare products Regulatory Agency (MHRA)

    Panelist

  • Vada Perkins

    Vice President, Global Head of Regulatory Intelligence & Policy · Boehringer Ingelheim

    Chair

  • Faizan Rahim

    Senior Regulatory Submission Manager · Roche

    Panelist

  • Steve Gens

    Managing Partner · Gens & Associates Inc.

    Panelist

  • Dominique Lagrave

    Chief Regulatory Officer · Accumulus Technologies

    Panelist