AGENDA
From 8.30am -Networking Breakfast
9:30-9:45am - Opening Remarks
• Emer Sherry, Senior Executive, Irish Medtech Association
• Mairead Twomey, Senior Director Regulatory Affairs, Stryker, Chair of QA/RA Forum
9:45-10:45am - Update on Article 10a and EU MDR/IVDR developments
• Erik Vollebregt, Partner, Axon Lawyers
10:45-11:30am - NBI TaskForce
• Elizabeth Delahunty, Associate Director, BD
11:30-11:45am - Networking Tea & Coffee Break
11:45am -12:45pm - Health Products Regulatory Authority (HPRA) update
• Nicola Hickie, Regulatory and Policy Manager, Medical Devices
12:45-1:00pm - Irish Medtech Skillnet
• Ann O’Connell, Head of Funded Networks, Medtech & Engineering
1:00pm-2:00pm - Networking Lunch
2:00-2:30pm - Public Consultation (Targeted Evaluation) on MDR/IVDR
• Emer Sherry, Senior Executive, Irish Medtech
• Mark Mullaney, Senior Director Regulatory Affairs, Merit Medical (tbc)
2:30-3:15pm - US FDA TaskForce /Digital Health TaskForce
• Elaine O’Connor, Senior Regulatory Affairs Director, Medtronic
3:00-3:05pm - Closing Remarks / Forum Close
Dates for diary