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DAY 1

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DAY 1

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08:00 - 08:2525 mins
Registration
    08:25 - 08:305 mins
    EU Medical Device Regulation
    Opening Remarks from Chair
    • Amanda Maxwell - Medtech Regulatory Affairs Editor, MedTech Insight, Pharma Intelligence, Informa, UK
    08:25 - 08:305 mins
    EU Medical Device Law
    Opening Remarks from Chair
    • Amanda Maxwell - Medtech Regulatory Affairs Editor, MedTech Insight, Pharma Intelligence, Informa, UK
    08:30 - 09:1040 mins
    EU Medical Device Regulation
    COMPETENT AUTHORITY FEEDBACK: First Experiences under EU MDR
    • Thomas Wejs Møller - Section Manager - Medical Devices, Danish Medicines Agency
    08:30 - 09:1040 mins
    EU Medical Device Law
    COMPETENT AUTHORITY FEEDBACK: First Experiences under EU MDR
    • Thomas Wejs Møller - Section Manager - Medical Devices, Danish Medicines Agency
    09:10 - 09:5040 mins
    EU Medical Device Regulation
    National Requirements with the MHRA
    • Gavia Taan - Unit Manager – Devices Regulatory Policy Devices Division, MHRA
    09:10 - 09:5040 mins
    EU Medical Device Law
    National Requirements with the MHRA
    • Gavia Taan - Unit Manager – Devices Regulatory Policy Devices Division, MHRA
    09:50 - 10:3040 mins
    EU Medical Device Regulation
    EU Medical Device Regulations, Notified Body overview and update from BSI
    • A Representative From BSI - BSI, BSI
    09:50 - 10:3040 mins
    EU Medical Device Law
    EU Medical Device Regulations, Notified Body overview and update from BSI
    • A Representative From BSI - BSI, BSI
    10:30 - 11:0030 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
    10:30 - 11:0030 mins
    EU Medical Device Law
    How Technology Can Simplify Compliance in the World of Global Regulatory Changes
    • Annemien Pullen - Director Strategy, Vault Medical Devices & Diagnostics, Veeva Systems
    11:00 - 11:3030 mins
    Coffee and Networking Break
      11:30 - 12:1545 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
      11:30 - 12:1545 mins
      EU Medical Device Law
      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
      12:15 - 13:0045 mins
      EU Medical Device Regulation
      KEYNOTE PANEL DISCUSSION: Implementation of the Person Responsible for Regulator Compliance (PRRC) in your Organisation
      • James Whitehead - Patient Safety Medical Device Lead, AstraZeneca
      12:15 - 13:0045 mins
      EU Medical Device Law
      KEYNOTE PANEL DISCUSSION: Implementation of the Person Responsible for Regulator Compliance (PRRC) in your Organisation
      • James Whitehead - Patient Safety Medical Device Lead, AstraZeneca
      13:00 - 14:2585 mins
      Networking Lunch
        14:25 - 14:305 mins
        EU Medical Device Regulation
        Opening Remarks from Chair
        • Amanda Maxwell - Medtech Regulatory Affairs Editor, MedTech Insight, Pharma Intelligence, Informa, UK
        14:25 - 14:305 mins
        EU Medical Device Law
        Opening Remarks from Chair
        • Alex Denoon - Partner, Bristows LLP, UK
        14:30 - 15:1040 mins
        EU Medical Device Law
        DUAL DIALOGUE: Transitional Provisions under the MDR and the IVDR
        • David van Passel - Assistant General Counsel, Johnson & Johnson, Belgium
        • Alex Denoon - Partner, Bristows LLP, UK
        14:30 - 15:0535 mins
        EU Medical Device Regulation
        Spotlight Session from NSF
        • Oliver P. Christ, Dipl.-Ing. - Heath Sciences Managing Director EMEA, NSF
        15:05 - 15:4035 mins
        EU Medical Device Regulation
        DUAL DIALOGUE: Economic Operators and Manufacturer's
        • Carol Mahon - Senior Director, EMEA Regulatory Compliance & Technical Services, Medtronic
        15:10 - 15:5040 mins
        EU Medical Device Law
        Legal Advice on the Economic Operators Regime: Have you Gone far Enough?
        • Peter Bogaert - Partner, Covington & Burling LLP, Belgium
        15:50 - 16:2030 mins
        Coffee and Networking Break
          16:20 - 16:5535 mins
          EU Medical Device Regulation
          Path to Compliance: the EU MDR
          • Shokoufeh Khodabandeh - MDR Implementation Lead, Institut Straumann AG
          16:20 - 17:0040 mins
          EU Medical Device Law
          Your Legal Relationship with your Notified Body
          • Erik Vollebregt - Partner, Axon Lawyers, The Netherlands
          16:55 - 17:3035 mins
          EU Medical Device Regulation
          CASE STUDY: How to Achieve CE Mark for Medical Devices
          • Jeffrey Cyr - Senior Manager, Regulatory Affairs, SirTex
          17:00 - 17:4040 mins
          EU Medical Device Law
          DUAL DIALOGUE Article 7: Putting Claims Requirements into Practice: Labelling, Advertising & Instruction
          • Laure Le Calvé - Managing Partner, LCH Avocats LLP, France
          • Wojciech Olszewski - Senior Legal Counsel EMEA, Align Technology, B.V., The Netherlands
          17:40 - 17:455 mins
          End of Conference Day 1
            NextDAY 2

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