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EU Pharmaceutical Law Forum
Delivered as a Hybrid Event 17-19 May 2022
Live In-Person Event: 17-19 May, Steigenberger Wiltcher's, BrusselsDigital Experience: All presentation recordings on-demand for 10 days from 24th May
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Wednesday 18th May - CET/CEST (Cent Europe Summer, GMT+2)

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Wednesday 18th May - CET/CEST (Cent Europe Summer, GMT+2)

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08:00 - 08:4545 mins
Conference Registration
    08:45 - 08:505 mins
    Regulatory Frameworks
    Opening Remarks by the Morning Chairperson
    • Eveline Van Keymeulen - Partner, Latham & Watkins
    08:50 - 09:3040 mins
    Regulatory Frameworks
    KEYNOTE EU Commission Update on the Regulatory Landscape
    • Florian Schmidt - Deputy Head of Unit, DG SANTE, European Commission
    09:30 - 10:3060 mins
    Regulatory Frameworks
    KEYNOTE PANEL Key Industry Takeaways from the Ongoing Pharmaceutical Legislative Reviews
    • Victoria Kitcatt - Vice President and Assistant General Counsel, Pfizer
    • Elise Melon - Legal Chief of Staff, Head of IP Policy & Operations, UCB
    • Florian Schmidt - Deputy Head of Unit, DG SANTE, European Commission
    • Eveline Van Keymeulen - Partner, Latham & Watkins
    • Marie Manley - Partner & Head of the UK Life Sciences Practice, Sidley Austin LLP
    10:30 - 11:0030 mins
    Networking Break
      11:00 - 11:3030 mins
      Regulatory Frameworks
      KEYNOTE EMA Update: Cooperation and Data Sharing Between Regulators
      • Martin Harvey - Head of International Affairs, European Medicines Agency (EMA)
      11:30 - 12:1545 mins
      Regulatory Frameworks
      Industry Implications of the European Health Emergency Preparedness and Response Authority (HERA)
      • Kristine Peers - General Counsel, EFPIA
      • Peter Bogaert - Partner, Covington & Burling LLP
      12:15 - 13:2570 mins
      Networking Lunch
        13:25 - 13:305 mins
        Regulatory Frameworks
        Opening Remarks from Afternoon Chairperson
        • Jordi Faus - Partner, Faus & Moliner
        13:30 - 14:1040 mins
        Regulatory Frameworks
        DUAL DIALOGUE Expanding Possibilities for Off-Label Use of Medicines & Regulatory Considerations on Related Topics
        • Catherine Longeval - Partner, Van Bael & Bellis
        • Evi Mathiou - Legal, Compliance & Quality Director, Novo Nordisk
        14:10 - 14:5040 mins
        Regulatory Frameworks
        DUAL DIALOGUE DUAL DIALOGUE Implications of the EU Clinical Trial Regulation (EU CTR)
        • Elisabethann Wright - Partner, Cooley
        • Claudia Muttin - Global Legal Lead – Prescription Global Business Unit, Galderma
        14:50 - 15:3040 mins
        Regulatory Frameworks
        DUAL DIALOGUE New Developments in the Regulation, Conduct and Use of Real-World Evidence
        • Hilary Jones - Senior Director, Legal Pharmaceutical Regulation, BioNTech UK Limited
        • Jacqueline Mulryne - Partner, Arnold & Porter
        15:30 - 16:0030 mins
        Networking Break
          16:00 - 16:5050 mins
          Regulatory Frameworks
          PANEL DISCUSSION A New Regulatory Frontier: EU AI Regulations
          • Gabriele Mazzini - Team Leader - Artificial Intelligence Policy & Regulation, DG Connect, European Commission (subject to confirmation)
          • James Clark - Senior Associate, DLA Piper
          • Alejandro Bes - Global Senior Legal Counsel, Digital, Novartis
          • Ulrich Juknat - Legal Director – Regulatory Law, EMEA, Johnson & Johnson Medical GMBH
          16:50 - 17:4050 mins
          Regulatory Frameworks
          PANEL Evolving Pharmaceutical Market Access Frameworks
          • Georgia Gavriilidou - Associate General Counsel, Amgen
          • Sophie Pelé - Partner, Dechert LLP
          • Christian Jervelund - Partner, Copenhagen Economics
          • Arianna Greco - SVP, Head of Global Commercial Legal, Alnylam Pharmaceuticals
          17:40 - 18:1030 mins
          Close of Regulatory Frameworks Day Followed by Networking Drinks Reception
            17:45 Registration • 18:00 Start • 20.00 End
            18:10 - 20:25135 mins
            Evening Seminar - Effective Market Access: Understanding HTA and Practical Negotiation Tips
            Effective Market Access: Understanding HTA and Practical Negotiation Tips
            • Marie Manley - Partner & Head of the UK Life Sciences Practice, Sidley Austin LLP
            • Zina Chatzidimitriadou - Managing Associate, Sidley Austin LLP
            • Chris Boyle - Senior Managing Associate, Sidley Austin LLP
            • Simon Costello - Associate General Counsel, UCB
            Tuesday 17th May
            NextThursday 19th May
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