08:30 – Registration and networking breakfast
09:30 - Forum opening address and sector update
• Mairead Twomey, Senior Director of Regulatory Affairs – Stryker
• Mark Mullaney, Senior Director, Regulatory Affairs - Merit Medical
• Dr Emer Sherry, Senior Executive - Irish Medtech
09:35 - EU MDR/IVDR – State of Play
• Petra Zoellner, Director IVDR/MDR – MedTech Europe
10:35 - Notified Body Update - NSAI
• Dr Claire Dyson, Director of Medical Devices – NSAI
11:25 – Networking tea and coffee break
11:40 - HPRA Update
• Dr Niall MacAleenan, Director of Medical Devices – HPRA
• James McCarthy, Regulatory and Policy Assessor, Medical Devices - HPRA
12:25 – US FDA TaskForce Update
• Elaine O’Connor, Director of Regulatory Affairs – Medtronic
12:55 – Networking lunch
13:55 - PFAS Update
• Veronica Reilly, Product Stewardship Manager – Abbott
14:25 – Global Regulatory TaskForce – Single Market Focus: Australia
• Nathan Van Sweden, Senior Director, Global Regulatory Affairs – Stryker
• Ian Phillips, Associate Director, Regulatory Affairs – Boston Scientific
14:55 – Notified Body Interactions TaskForce - Focus on eIFU
• Elizabeth Delahunty, Associate Director, Regulatory Affairs - BD
• Shauna Coen, Senior II, Strategic Regulatory Affairs - Aerogen
15:25 – Closing remarks
• Dr Emer Sherry, Senior Executive - Irish Medtech