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DAY TWO

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DAY TWO

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09:00 - 09:1010 mins
Regulatory Frameworks
Chairs Opening Remarks
    09:10 - 09:4030 mins
    Regulatory Frameworks
    KEYNOTE PRESENTATION EU Commission Update on the Regulatory Landscape
    • Florian Schmidt - Deputy Head of Unit, DG SANTE, European Commission
    09:40 - 10:1030 mins
    Regulatory Frameworks
    KEYNOTE PRESENTATION EMA Approach to Transparency of Pharmaceutical Data
    • Stefano Marino - Head of Department, European Medicines Agency (subject to final confirmation)
    10:10 - 10:4030 mins
    Regulatory Frameworks
    New Developments in Orphan and Paediatric Medicines
    • Victoria Kitcatt - VP & Assistant General Counsel, EU and International Regulatory Law, Pfizer, UK
    10:40 - 11:1030 mins
    Networking Break
      11:10 - 11:4030 mins
      Regulatory Frameworks
      New Developments on Availability and Shortage of Medicine Across Europe
      • Kristine Peers - General Counsel, EPFIA
      11:40 - 12:4060 mins
      Regulatory Frameworks
      PANEL DISCUSSION Affordability of Medicines, Price Transparency and Market Access
      • Arianna Greco - Vice President, Head of International Legal, Alnylam Pharmaceuticals, Switzerland
      • Sophie Pelé - National Partner, Dechert LLP, France
      • Christian Jervelund - Managing Partner, Copenhagen Economics, Denmark
      12:40 - 14:1090 mins
      Networking Lunch
        14:10 - 14:5040 mins
        Regulatory Frameworks
        DUAL DIALOGUE: Regulatory Frameworks for ATMPs: Focus on Cell and Gene Therapy
        • Marco de Morpurgo - Partner, Global Co-Chair, Life Sciences Sector, DLA Piper, Italy
        • George Pickering - Assistant General Counsel, Pharma R&D, Oncology and European Medical, GlaxoSmithKline, UK
        14:50 - 15:3040 mins
        Regulatory Frameworks
        DUAL DIALOGUE Legal Considerations Regarding the Use of Unapproved Products
        • Catherine Longeval - Partner, Van Bael & Bellis, Belgium
        • Hilary Jones - Senior Director, Legal, Gilead Sciences, UK
        15:30 - 16:0030 mins
        Networking Break
          16:00 - 16:4040 mins
          Regulatory Frameworks
          DUAL DIALOGUE EU MDR Regulations for eHealth, Mobile Apps and Artificial Intelligence
          • Giorgio Rizzello - Legal Director EMEA, Johnson & Johnson, Belgium
          • Marc Martens - Partner, Co-Head of the International Life Sciences and Healthcare Group, Bird & Bird LLP, Belgium
          16:40 - 17:2040 mins
          Regulatory Frameworks
          Pharmaceutical Marketing, Advertising and Promotional Activity
          • Ilja Moree - Head Legal Oncology Region Europe, Italy, Novartis, Italy
          17:20 - 18:0545 mins
          Close of Day Two Followed by Networking Drinks Reception
            EVENING SEMINARS
            18:05 - 18:2015 mins
            Seminar: Market Access for Innovative Therapies
            Registration
              18:05 - 18:2015 mins
              Seminar: EU MDR & IVDR for Pharmaceutical Firms
              Registration
                18:20 - 20:05105 mins
                Seminar: Market Access for Innovative Therapies
                MARKET ACCESS FOR INNOVATIVE THERAPIES
                • Alexander Roussanov - Partner, Arnold & Porter LLP, Belgium
                • Adela Williams - Partner, Arnold & Porter LLP, UK
                • Marieke Jansen - Head Legal Cell and Gene Europe, Novartis, Switzerland
                18:20 - 20:05105 mins
                Seminar: EU MDR & IVDR for Pharmaceutical Firms
                EU MDR & IVDR FOR PHARMACEUTICAL FIRMS
                • Erik Vollebregt - Partner, Axon Lawyers, The Netherlands
                DAY ONE
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