Day 1

Thursday, October 29, 2020

Time Event

1:30 PM – 1:35 PM

Irish Medtech Association, Welcome

John O’Brien, IMA Board Chair

1:35 PM – 1:55 PM

Opening Address, HPRA

Lorraine Nolan, CEO, Health Products Regulatory Authority

1:55 PM – 2:10 PM

Keynote Address

2:10 PM – 2:45 PM

Session 1: A new era for medical devices regulations in the EU

Petra Zoellner, Senior Manager Regulations & Industrial Policy, MedTech Europe

Merlin Rietschel, Senior Manager Regulations & Industrial Policy, MedTech Europe

Mairead Finucane, Project Lead & Inspector for Joint Assessments of NB’s DG Sante


2:45 PM – 3:10 PM

Networking break

3:10 PM – 4:20 PM

Session 1 contd.: A New Era For Medical Device Regulations In The EU

Niall MacAleenan, Head of Medical Devices, HPRA

Jon Goveia, Director, Regulatory Affairs, Program Manager – EU IVDR, Abbott Diagnostics

Ger Finn, VP RA, Medtronic

Participant Q&A

4:20 PM – 4:40 PM

Networking break

4:40 PM – 5:25 PM

Session 2: The changing global regulatory landscape – opportunities and challenges for business – ‘the USA is open for business’

Joe Gatewood, VP Global Strategy, AdvaMed

John Knorpp, Chief Regulatory Affairs Officer, Merit Medical Systems

Olive O’Driscoll, Founder and Director of AventaMed

Participant Q&A

5:30 PM – 5:35 PM

Closing Remarks

5:35 PM – 5:40 PM

Conference Close – Day 1

Day 2

Friday, October 30, 2020

Time Event

8:35 AM – 9:10 AM

Session 3: The Modern QA/RA Professional and Lifelong Learning

Ann O’Connell, Head of Funded Projects for Medtech and Engineering, Ibec

Jack Sherwood, QA Manager, Alcon

Noeleen McCullagh, Graduate in QA, Boston Scientific Galway

9:10 AM – 9:50 AM

Session 4: The Medtech Business Macroenvironment in Challenging Times – Brexit and Covid – 19

Bill Doherty, Cook Medical & MTE Board

Ger Brady, Chief Economist, Ibec

Nicola Hickie, Regulatory and Policy Manager, Medical Devices, HPRA

9:50 AM – 10:50 AM

Session 5: The Changing Global Regulatory Landscape – Opportunities and Challenges For Business

Jianying (Jane) Lin, Senior Director Regulatory Affairs Lead ASPAC, Johnson & Johnson

Leslie Kim, Director, RA/QA Stryker

Charleen O’Keeffe, Partner, William Fry

10:50 AM – 11:10 AM

Networking break

11:10 AM – 12:10 PM

Session 6: How Notified Bodies and Other Stakeholders are Helping Businesses Manage MDR/IVDR

Colm O’Rourke, Industry Engagement Medical Devices, NSAI

Gert W. Bos, QServe Executive Director & Partner

Gary Slack, Senior Vice President – Global Medical Devices, BSI Group

Martin Witte, Global Director, Active Implantable and Cardiovascular Devices, TÜV SÜD

12:10 PM – 12:25 PM

Networking break

12:25 PM – 1:10 PM

Session 7: The Case For Quality – New Approaches to Business

Francisco Vicenty, Program Manager, Case for Quality, US FDA, CDRH/Office of Compliance

Bleta Vuniqi, Compliance and Quality Staff, US FDA

Rosaleen Burke, SVP, Global Quality & Regulatory, Boston Scientific

Karen Hyland, Snr. Reg Manager Galway, Medtronic

Fidelma Sheerin, Senior Manager Corporate Quality, Stryker

1:10 PM – 1:15 PM

Irish Medtech Association, Closing remarks

© 2020 Global Access – Medtech QA/RA Virtual Conference Privacy Policy