Irish Medtech Quality and Regulatory Forum
Wednesday, 5th July 2023, Radisson Blu Hotel, Limerick
AGENDA
From 8.30am
Networking Breakfast
9:30-9:40am
Opening Remarks,
Dr Emer Sherry, Senior Executive, Irish Medtech Association
9:40-10:45 am
Implementing Regulation 2023/607 [20 mins]
• Olga van Grol Lawlor, Manager Global Regulatory Intelligence & Advocacy, Boston Scientific
• John O’Sullivan, Industry Engagement Officer, NSAI
Panel discussion
• Paul Cahalan, Regulatory Affairs Fellow, BSCI
• Sean O’Callaghan, IVDR/MDR European Medical Device Operations Manager and Co-Head, NSAI
• Nathan Van Sweden, Director, Regulatory Affairs, Stryker
• Laura Guinane, Regulatory Affairs Program Manager, Medtronic
• John O’Dea, CEO, Palliare
10:45-11:15am
Economic Operators & Supply Chain Task Force update
• Ida Foley, Director RA, Teleflex
• Olga Van Grol Lawlor, Manager Global Regulatory Intelligence & Advocacy, Boston Scientific
• Yolanthe Gwaba, Senior Regulatory Specialist, Bausch + Lomb’s Vision Care
11:15-11:30am
Networking Tea & Coffee Break
11:30-11:50am
High level Overview of Digital Policy & Regulation for QA/RA professionals (including Data and AI)
Erik O’Donovan, Head of Digital Economy Policy, Ibec
11:50- 13.00pm
Software as Medical Device Task Force
• Niamh Lynch, Director of Regulatory Affairs and Quality | Atlantic Therapeutics
• Padraig Maguire, Head of Quality & Regulatory Affairs, S3 Connected Health
• Killian Haycock, Quality Manager, Bluebridge technologies
1:00pm-2:15pm
Networking Lunch
2:15-2:30pm
Digital Health Regulatory Training / Future Skills Report
• Jennifer McCormack, Connected Health Skillnet Manager, Ibec
2:30-3:30pm
QMS Impacts and Audits Task Force
• Fidelma Sheerin, Chief Specialist, Corporate Quality, Stryker
• Ann Hunt, Senior Quality Systems Manager, Medtronic
3:30-3:35pm
Closing Remarks / Forum Close
Dates for diary