Irish Medtech Quality and Regulatory Forum

Tuesday, 14 March 2023, Radisson Blu Hotel, Limerick

AGENDA

From 8.30am Networking Breakfast
9:00-9:10am Opening Remarks
Dr Emer Sherry, Senior Executive, Irish Medtech Association 
John Kilmartin, Vice-President of Regulatory Affairs, Medtronic

9:10-9:30am The EU Medical Device Regulation - current state of play 
Olga van Grol-Lawlor, Manager Global Regulatory Intelligence & Advocacy, Boston Scientific
9:30-10:45am The EU MDR Amendment - how are companies responding?
Moderator: Robbie Walsh, Director, Regulatory Affairs, Boston Scientific, 
Panel:
• Olga van Grol-Lawlor, Boston Scientific
• Nathan Van Sweden, Director, Regulatory Affairs, Stryker
• Caroline Walsh, Senior Director QARA, Aerogen
• Karen Hyland, Director of Regulatory Affairs, Medtronic
• Paul Cahalan, Regulatory Affairs Fellow, Boston Scientific
10:45-11:15am
  Networking Tea & Coffee Break
11:15-12:15pm HPRA Update
Dr Niall MacAleenan, Director of Medical Devices, HPRA 
Nicola Hickie, Regulatory and Policy Manager, HPRA
Q&A
12:15-1:00pm Notified Body Interactions Task Force   
Paul Cahalan, Regulatory Affairs Fellow, Boston Scientific
Elizabeth Delahunty, Associate Director, Regulatory Affairs, BD
Danica Murphy, Regulatory Affairs Specialist, Medtronic
Eileen Looby, Senior Regulatory Affairs, Abbott Vascular
1:00pm-2:00pm Networking Lunch
2:00-2:45pm PMS and Vigilance Task Force
Una Barry, Principal RA Compliance Specialist, Stryker
Mark Mullaney, Senior Director, Regulatory Affairs, Merit Medical
Mairead Ryan, Program Manager, Medtronic
2:45-3:30pm Clinical Evaluation Task Force
Mark Mullaney, Senior Director, Regulatory Affairs, Merit Medical
Ian Philips, Regulatory Affairs Manager, Boston Scientific
John O’Dwyer, Medical Director EMEA, Teleflex Medical
3:30-3:35pm Closing Remarks / Forum Close