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DAY 1 - 12th Oct 2020keyboard_arrow_right

DAY 1 - 12th Oct 2020 - CEST

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DAY 1 - 12th Oct 2020 - CEST

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10:00 - 10:1010 mins
Platform Tutorial
    10:20 - 10:3010 mins
    Opening Remarks
      10:30 - 10:4010 mins
      EU Medical Device Regulation
      Moderated by: AMANDA MAXWELL Medtech Regulatory Affairs Editor, MedTech Insight, Pharma Intelligence at Informa, UK
      • Amanda Maxwell - Medtech Regulatory Affairs Editor, MedTech Insight, Pharma Intelligence, Informa, UK
      10:30 - 10:4010 mins
      EU Medical Device Law
      Moderated by Josefine Sommer, Senior Associate, Sidley Austin LLP, Brussels
        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
        12:10 - 12:3525 mins
        EU Medical Device Law
        ROUNDTABLE: The Top 5 Legal Pitfalls for Software Medical Device Developers
        • Michaela Herron - Partner, Mason, Hayes & Curran, Ireland
        • Erik Vollebregt - Partner, Axon Lawyers, The Netherlands
        • Alex Denoon - Partner, Bristows LLP, UK
        12:25 - 13:1045 mins
        EU Medical Device Regulation
        Let's Get Moving - PT Session
          13:10 - 13:3020 mins
          Networking Break
            13:30 - 13:355 mins
            EU Medical Device Regulation
            Moderated by Amélie Chollet, Legal Regulatory Counsel, Abbott Laboratories, UK
              13:30 - 13:355 mins
              EU Medical Device Law
              Moderated by Amélie Chollet, Legal Regulatory Counsel, Abbott Laboratories, UK
                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 - 14:5510 mins
                Tech Tour: Mason Hayes and Curran
                  15:00 - 15:1010 mins
                  Tech Tour: BSI
                    15:10 - 15:4030 mins
                    Exhibition Networking Break – A chance to meet with stakeholders, sponsors and fellow attendees
                      15:40 - 15:455 mins
                      EU Medical Device Regulation
                      Moderated by DANIELA LEAL Global Regulatory Affairs Lead MDR/IVDR at Zimmer Biomet
                      • Daniela Leal - Global Regulatory Affairs Lead MDR/IVDR, Zimmer Biomet
                      15:40 - 15:455 mins
                      EU Medical Device Law
                      Moderated by Annabelle Bruyndonckx, Of Counsel, Simmons and Simmons, Brussels
                        15:45 - 16:1025 mins
                        EU Medical Device Law
                        Your Legal Relationship with your Notified Body
                        • Erik Vollebregt - Partner, Axon Lawyers, The Netherlands
                        15:50 - 16:1525 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
                        16:15 - 16:4025 mins
                        EU Medical Device Law
                        Article 7: Putting Claims Requirements into Practice - Labelling, Advertising & Instruction
                        • Josefine Sommer - Associate, Sidley Austin, Belgium
                        16:20 - 16:4525 mins
                        EU Medical Device Regulation
                        How to Achieve the CE Mark for Medical Devices
                        • Jeffrey Cyr - Global Director, Regulatory Affairs, Sirtex Medical Inc
                        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
                        16:50 - 17:1525 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
                        17:20 - 17:3010 mins
                        Taste of Dublin
                          17:30 - 18:5080 mins
                          Speed Networking
                            NextDAY 2 - 13th Oct 2020

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