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DAY 1 - 12th OCTkeyboard_arrow_right

DAY 1 - 12th OCT

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DAY 1 - 12th OCT

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10:30 - 10:355 mins
Opening Remarks
    10:35 - 11:0025 mins
    EU Medical Device Regulation
    Path to Compliance: Industry EU MDR
    • Shokoufeh Khodabandeh - MDR Implementation Lead, Institut Straumann AG
    10:35 - 11:0025 mins
    EU Medical Device Law
    Implementation of the Person Responsible for Regulatory Compliance (PRRC) in your Organisation
    • James Whitehead - Patient Safety Medical Device Lead, AstraZeneca
    • Alex Denoon - Partner, Bristows LLP, UK
    11:00 - 11:2525 mins
    EU Medical Device Regulation
    Impact of COVID19 on the EU MDR
    • Erik Vollebregt - Partner, Axon Lawyers, The Netherlands
    11:00 - 11:2525 mins
    EU Medical Device Law
    Legal Advice on the Economic Operators Regime: Have You Gone Far Enough?
    • Peter Bogaert - Partner, Covington & Burling LLP, Belgium
    11:25 - 11:5025 mins
    EU Medical Device Regulation
    PANEL DISCUSSION: Industry Feedback on the Implementation of the EU MDR
    • Juliette Cook - Regional Regulatory Director EMEA, Cochlear AG, Switzerland
    • Inge Vandenbussche - Director Regulatory Affairs EMEA, Medtronic
    • Shokoufeh Khodabandeh - MDR Implementation Lead, Institut Straumann AG
    • Daniela Leal - Global Regulatory Affairs Lead MDR/IVDR, Zimmer Biomet
    • Alexander Natz - Director General, EUCOPE, Belgium
    11:25 - 11:5025 mins
    EU Medical Device Law
    Transitional Provisions under the EU MDR and IVDR
    • David van Passel - Assistant General Counsel, Johnson & Johnson, Belgium
    11:50 - 13:0070 mins
    Exhibition Networking Break – A chance to meet with stakeholders, sponsors and fellow attendees
      13:00 - 13:3030 mins
      EU Medical Device Regulation
      National Requirements
      • Gavia Taan - Unit Manager – Devices Regulatory Policy Devices Division, MHRA
      13:00 - 13:3030 mins
      EU Medical Device Law
      National Requirements
      • Gavia Taan - Unit Manager – Devices Regulatory Policy Devices Division, MHRA
      13:30 - 14:0030 mins
      EU Medical Device Regulation
      EU Medical Device Regulations, Notified Body Overview and Update from BSI
        13:30 - 14:0030 mins
        EU Medical Device Law
        EU Medical Device Regulations, Notified Body Overview and Update from BSI
          14:00 - 15:0060 mins
          Exhibition Networking Break – A chance to meet with stakeholders, sponsors and fellow attendees
            15:00 - 15:2525 mins
            EU Medical Device Regulation
            How Technology Can Simplify Compliance in the World of Global Regulatory Changes
            • Annemien Pullen - Director Strategy, Vault Medical Devices & Diagnostics, Veeva Systems
            15:00 - 15:2525 mins
            EU Medical Device Law
            Your Legal Relationship with your Notified Body
            • Erik Vollebregt - Partner, Axon Lawyers, The Netherlands
            15:25 - 15:5025 mins
            EU Medical Device Regulation
            How to Achieve the CE Mark for Medical Devices
            • Jeffrey Cyr - Senior Manager, Regulatory Affairs, Sirtex Medical Inc
            15:25 - 15:5025 mins
            EU Medical Device Law
            Article 7: Putting Claims Requirements into Practice - Labelling, Advertising & Instruction
            • Laure Le Calvé - Managing Partner, LCH Avocats LLP, France
            15:50 - 16:1525 mins
            EU Medical Device Regulation
            MDR: End of transition period – What happens to the EU Medical Device Market next?
            • Oliver P. Christ, Dipl.-Ing. - Health Sciences Managing Director EMEA, NSF
            15:50 - 16:1525 mins
            EU Medical Device Law
            Product Liability, Sufficient Financial Coverage and EU MDR: Where are we?
            • Michaela Herron - Partner, Mason, Hayes & Curran, Ireland
            16:15 - 16:4025 mins
            EU Medical Device Regulation
            Spotlight Session from Trinzo
              16:40 - 18:0080 mins
              Networking activity
                NextDAY 2 - 13th OCT

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