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DAY 1 - 12th Oct 2020 - GMT Time Zone
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DAY 1 - 12th Oct 2020 10:00 - 10:1010 mins
Platform Tutorial
DAY 1 - 12th Oct 2020 10:20 - 10:3010 mins
Opening Remarks
DAY 1 - 12th Oct 2020 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
DAY 1 - 12th Oct 2020 10:30 - 10:4010 mins
EU Medical Device Law
Moderated by Josefine Sommer, Senior Associate, Sidley Austin LLP, Brussels
DAY 1 - 12th Oct 2020 10:40 - 11:0525 mins
EU Medical Device Regulation
Path to Compliance: Industry EU MDR
- Shokoufeh Khodabandeh - MDR Implementation Lead, Institut Straumann AG
DAY 1 - 12th Oct 2020 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
DAY 1 - 12th Oct 2020 11:10 - 11:3525 mins
EU Medical Device Regulation
Impact of COVID19 on the EU MDR
- Erik Vollebregt - Partner, Axon Lawyers, The Netherlands
DAY 1 - 12th Oct 2020 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
DAY 1 - 12th Oct 2020 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
DAY 1 - 12th Oct 2020 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
DAY 1 - 12th Oct 2020 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
DAY 1 - 12th Oct 2020 12:25 - 13:1045 mins
EU Medical Device Regulation
Let's Get Moving - PT Session
DAY 1 - 12th Oct 2020 13:10 - 13:3020 mins
Networking Break
DAY 1 - 12th Oct 2020 13:30 - 13:355 mins
EU Medical Device Regulation
Moderated by Amélie Chollet, Legal Regulatory Counsel, Abbott Laboratories, UK
DAY 1 - 12th Oct 2020 13:30 - 13:355 mins
EU Medical Device Law
Moderated by Amélie Chollet, Legal Regulatory Counsel, Abbott Laboratories, UK
DAY 1 - 12th Oct 2020 13:35 - 14:0530 mins
EU Medical Device Regulation
National Requirements
- Gavia Taan - Unit Manager – Devices Regulatory Policy Devices Division, MHRA
DAY 1 - 12th Oct 2020 13:35 - 14:0530 mins
EU Medical Device Law
National Requirements
- Gavia Taan - Unit Manager – Devices Regulatory Policy Devices Division, MHRA
DAY 1 - 12th Oct 2020 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
DAY 1 - 12th Oct 2020 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
DAY 1 - 12th Oct 2020 14:45 - 14:5510 mins
Tech Tour: Mason Hayes and Curran
DAY 1 - 12th Oct 2020 15:00 - 15:1010 mins
Tech Tour: BSI
DAY 1 - 12th Oct 2020 15:10 - 15:4030 mins
Exhibition Networking Break – A chance to meet with stakeholders, sponsors and fellow attendees
DAY 1 - 12th Oct 2020 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
DAY 1 - 12th Oct 2020 15:40 - 15:455 mins
EU Medical Device Law
Moderated by Annabelle Bruyndonckx, Of Counsel, Simmons and Simmons, Brussels
DAY 1 - 12th Oct 2020 15:45 - 16:1025 mins
EU Medical Device Law
Your Legal Relationship with your Notified Body
- Erik Vollebregt - Partner, Axon Lawyers, The Netherlands
DAY 1 - 12th Oct 2020 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
DAY 1 - 12th Oct 2020 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
DAY 1 - 12th Oct 2020 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
DAY 1 - 12th Oct 2020 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
DAY 1 - 12th Oct 2020 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
DAY 1 - 12th Oct 2020 17:20 - 17:3010 mins
Taste of Dublin
DAY 1 - 12th Oct 2020 17:30 - 18:5080 mins
Speed Networking
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