Agenda
From 8.30am
Networking Breakfast
9:30-9:40am
Opening Remarks
• Emer Sherry, Senior Executive, Irish Medtech Association
• Mairead Twomey, Senior Director, Stryker, Chair of QA/RA Forum
9:45-10:30am
AI Act and MDR/IVDR
• Ben Meaney, Manager Software, Digital and AI Regulation, Medtech Europe
10:30-11:15am
US FDA Task Force
• Elaine O’Connor, Regulatory Affairs Director, Medtronic
• Rosin Slevin, Senior Regulatory Affairs Manager, Veryan Medical
• Mairead Twomey, Senior Director, Stryker, Chair of QA/RA Forum
11:15-11:30am
Networking Tea & Coffee Break
11:30 -12:30pm
Health Products Regulatory Authority (HPRA) update
• Nicola Hickie, Regulatory and Policy Manager, Medical Devices
• Niall MacAleenan, Director of Medical Devices
12:30-12:45pm
Irish Medtech Skillnet Masters in Medtech Regulatory Affairs Review
• Ann O’Connell, Head of Funded projects, Medtech and Engineering
12:45pm-2:00pm Networking Lunch
2:00-2:30pm
IVD Task Force
• Tommy McDonagh, Associate Director Regulatory Affairs, Abbott Core Diagnostics
• Susan Dwane, Regulatory Manager, Serosep
2:30-3:00pm
Notified Body Interactions Task Force
• Elizabeth Delahunty, Associate Director, Regulatory Affairs, BD
• Danica Murphy, Regulatory Affairs Specialist, Medtronic
• Paul Cahalan, Associate Snr. Fellow, Boston Scientific
• Eileen Looby, Senior Regulatory Affairs Manager, Abbott
3:00-3:05pm
Closing Remarks / Forum Close
Dates for diary