08:45 | Opening |
08:45 | Welcome & Introduction to the Medtech in Ireland
John O’Dea, IMDA Vice-Chair , Director & CEO Crospon |
08:50 | Formal Conference Opening
Minister Department of Health (invited) |
SESSION ONE: | Chair - IMDA Regulatory Steering Committee |
09:00 | Responsible innovation - an appropriate regulatory framework for patients in Europe
Bill Doherty, Exec Vice President EMEA, Cook Medical |
09:25 | MDD revision – changes to the EU Regulatory Framework
Jaqueline Minor, Director of Consumer Affairs, DG SANCO (Health and Consumers), European Commission |
10:05 | Q&A |
10:15 - 10:45 | Coffee Break |
10:45 | The IMB and Medical Device Regulation & the authority’s perspective on proposed revision to the MDD
Ann O’Connor, Director of Human Products Authorisation & Registration, IMB |
11:25 | Notified body perspective on changes to the EU Regulatory Framework
Gert Bos, Vice-Chair of the Notified Body Forum (NB-Med), Head of Regulatory and Clinical Affairs at BSI Group |
11:55 | Industry perspective on MDD revision & changes to the EU Regulatory Framework
Tanya Valentin, Senior Manager Public Affairs, Eucomed |
12:25 | Panel Discussion
Bill Doherty, Cook Medical
Jaqueline Minor, EU Commission
Ann O’Connor, IMB
Tanya Valentin, Eucomed
Gert Bos, NB-MED
John O’Dwyer, NSAI |
13:00 - 14:00 | Lunch |
SESSION TWO: | Chair - IMDA Regulatory Steering Committee |
14:05 | Current compliance and enforcement trends at FDA & the proposed 510(k) program changes/reform process at FDA
Steven Silverman (by videolink), Director, Office of Compliance, CDRH, FDA
Marjorie Shulman*, Director, Premarket Notification (510(k)) Program |
14:50 | Recent trends in US regulation and implications for industry (an industry perspective)
Tamima Itani, Vice President, Global Regulatory Affairs & Regulatory Compliance, Boston Scientific (co-chair Advamed 510(k) working group) |
15:20 | Q&A |
15:30 - 16:00 | Coffee Break |
SESSION THREE: | Chair - IMDA Regulatory Steering Committee |
16:05 | Regulatory Developments in Russia and the Middle East
Dominik Reterski, Senior Director Regulatory Affairs EMEA, Covidien Europe |
16:30 | Medical device regulation in China – regulatory and practical challenges
Ruby Liu, Regulatory Affairs Manager, Cook Medical, China |
16:55 | Overview of the regulatory framework in India from an industry perspective
Gaurav Verma, Head of Regulatory Affairs, Boston Scientific India Hub |
17:25 | Q&A |
17:35 | Closing Remarks and meeting close |
19:00 | Conference Dinner
Guest of Honour Nessa Childers, MEP and member of the European Parliament's Committee on the Environment, Public Health and Food Safety |