AGENDA
QARA Forum
11 July 2024 - DRAFT AGENDA
From 8.30am Networking Breakfast
9:30-9:40am - Opening Remarks /EU elections update/Global Access
Emer Sherry, Senior Executive, Irish Medtech Association
Mairead Twomey, Senior Director of Regulatory Affairs, Stryker, Chair of QA/RA Forum
9:50-10:30am - Overview of MDR / IVDR Developments
Olga van Grol Lawlor, Senior Global Regulatory Intelligence & Advocacy Manager, Boston Scientific
10:30-11:15am - QMS, PMS and Audits TaskForce
Fidelma Sheerin, Chief Specialist, Corporate Quality, Stryker
Ann Hunt, Senior Quality Systems Manager, Medtronic
Catriona Conroy, Post Market Quality Lead, BD
11:15-11:30am Networking Tea & Coffee Break
11:30 -12:00pm - Notified Body update – TUV SUD
Ruairí McCaul, Medical device Lead Auditor, Product Client Manager and Regulatory Specialist, TUV SUD
12:00-12:30pm - US FDA Task Force
Elaine O’Connor, Director of Regulatory Affairs, Medtronic
12:30-12:45pm - Irish Medtech Springboard Course - Regulatory Affairs
Carmel McGrath, VP RA, Head Diagnostics & ATU Lecturer
Ann O’Connell, Head of Funded Projects, Medtech and Engineering
12:45-1:00pm - Introduction to Combination Products working group
Paul Scannell, Senior Director Regulatory Affairs, West Pharma
Tara Cox, Head of Device Quality and Regulatory Compliance, Takeda
1:00pm-2:00pm -Networking Lunch
2:00-2:30pm - Notified Body Interactions TaskForce
Elizabeth Delahunty, Associate Director, Regulatory Affairs, BD
2:30-3:30pm - Overview of Environmental Sustainability Regulations
Sigrid Linher, Director Sustainability & Environment, Medtech Europe
Jenny Hughes, Environmental Sustainability Executive, Irish Medtech
3:30-3:35pm - Closing Remarks / Forum Close
Dates for diary