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Clinical Trial Events
DIA Europe

Talk CMC & Product Quality track

S0204 - Innovation: Regulatory Tools, approaches and ways of working to facilitate the implementation of Innovation

Thu, Mar 20, 2025 · 8:30–9:40 AM CET Montreal Room, Congress Center Basel

About this session

This session will be covering how regulatory tools can enable innovation, particularly around how we can progress toward the new concepts and progress the use advancement techniques in pharmaceutical manufacturing.

Programme:
- 3. Sharing Sanofi's Experience of Existing Regulatory Tools and Vaccines as Lessons Learned to Build the Platform Technology Concept — Tran Ba Quang Truong
- Panel Discussion — Marcel Hoefnagel, Evdokia  Korakianiti, Gert Thurau, Meena Ram, Stuart Finnie
- 5. EMA Quality Innovation Group: Two years experience in regulatory support of Innovation in pharmaceutical manufacturing — Marcel Hoefnagel
- 1. Setting the scene — Stuart Finnie
- 4. Manufacturing Innovation Case Study – Overcoming regulatory hurdles of Artificial Intelligence Implementation in Manufacturing (without hallucinating) — Gert Thurau
- 2. Enabling Regulatory Frameworks to Foster Innovation — Meena Ram

Speakers

  • Tran Ba Quang Truong

    Head GRA CMC, mRNA · Sanofi

    Speaker

  • Stuart Finnie

    Senior Director, Regulatory Affairs CMC · Gilead

    Chair

  • Marcel Hoefnagel

    Senior Assessor Biopharmaceuticals · Medicines Evaluation Board

    Speaker

  • Meena Ram

    Senior Director · Amicus Therapeutics

    Speaker

  • Gert Thurau

    CMC Reg Policy lead for manufacturing innovation · F . Hoffman-La Roche

    Speaker

  • Evdokia  Korakianiti

    Head of Quality and Safety of Medicines · European Medicines Agency

    Chair