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DAY 1 - 12th OCTkeyboard_arrow_right

DAY 1 - 12th OCT - CEST

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DAY 1 - 12th OCT - CEST

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10:30 - 10:355 mins
Opening Remarks
    10:40 - 11:0525 mins
    EU Medical Device Regulation
    Path to Compliance: Industry EU MDR
    • Shokoufeh Khodabandeh - MDR Implementation Lead, Institut Straumann AG
    10:40 - 11:0525 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
    11:10 - 11:3525 mins
    EU Medical Device Regulation
    Impact of COVID19 on the EU MDR
    • Erik Vollebregt - Partner, Axon Lawyers, The Netherlands
    11:10 - 11:3525 mins
    EU Medical Device Law
    Legal Advice on the Economic Operators Regime: Have You Gone Far Enough?
    • Peter Bogaert - Partner, Covington & Burling LLP, Belgium
    11:40 - 12:2040 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
    11:40 - 12:0525 mins
    EU Medical Device Law
    Transitional Provisions under the EU MDR and IVDR
    • David van Passel - Assistant General Counsel, Johnson & Johnson, Belgium
    12:25 - 13:3570 mins
    Exhibition Networking Break – A chance to meet with stakeholders, sponsors and fellow attendees
      13:35 - 14:0530 mins
      EU Medical Device Regulation
      National Requirements
      • Gavia Taan - Unit Manager – Devices Regulatory Policy Devices Division, MHRA
      13:35 - 14:0530 mins
      EU Medical Device Law
      National Requirements
      • Gavia Taan - Unit Manager – Devices Regulatory Policy Devices Division, MHRA
      14:10 - 14:4030 mins
      EU Medical Device Regulation
      EU Medical Device Regulation, Notified Body Overview and Update from BSI
      • Maddalena Pinsi - Regulatory Manager, Regulatory Services - Notified Body, BSI
      • Suzanne Halliday - Regulatory Director & Head of Notified Body, BSI
      14:10 - 14:4030 mins
      EU Medical Device Law
      EU Medical Device Regulation, Notified Body Overview and Update from BSI
      • Maddalena Pinsi - Regulatory Manager, Regulatory Services - Notified Body, BSI
      • Suzanne Halliday - Regulatory Director & Head of Notified Body, BSI
      14:45 - 15:4560 mins
      Exhibition Networking Break – A chance to meet with stakeholders, sponsors and fellow attendees
        15:45 - 16:1025 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
        15:45 - 16:1025 mins
        EU Medical Device Law
        Your Legal Relationship with your Notified Body
        • Erik Vollebregt - Partner, Axon Lawyers, The Netherlands
        16:15 - 16:4025 mins
        EU Medical Device Regulation
        How to Achieve the CE Mark for Medical Devices
        • Jeffrey Cyr - Senior Manager, Regulatory Affairs, Sirtex Medical Inc
        16:15 - 16:4025 mins
        EU Medical Device Law
        Article 7: Putting Claims Requirements into Practice - Labelling, Advertising & Instruction
        • Laure Le Calvé - Managing Partner, LCH Avocats LLP, France
        16:45 - 17:1025 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
        16:45 - 17:1025 mins
        EU Medical Device Law
        Product Liability, Sufficient Financial Coverage and EU MDR: Where are we?
        • Michaela Herron - Partner, Mason, Hayes & Curran, Ireland
        17:15 - 18:3580 mins
        Networking activity
          NextDAY 2 - 13th OCT

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