QARA Forum Agenda
05 March 2026 | 09:30 – 15:30 GMT | Radisson Blu, Limerick
8:30 – Registration open and networking breakfast
9:30 – Forum opening address and Irish Medtech update
- Mairead Twomey - QARA Forum Chair, Senior Director Regulatory Affairs, Stryker
- Toma Pervan – Executive, Irish Medtech
9:40 – European Commission’s Proposal for a Regulation to Simplify Rules on MDs and IVDs (panel discussion)
- Peter Bischoff-Everding - Senior Expert, European Commission (virtual)
- Mark Mullaney - Senior Director, Regulatory Affairs, Merit Medical
- Thomas McDonagh - Associate Director Regulatory Affairs (IVDR), Abbott
- Emer Sherry - Senior Executive, Irish Medtech (moderator)
10:30 – In Conversation with Global Regulatory Leaders - Yarmela Pavlovic, Medtronic
- Yarmela Pavlovic - Chief Regulatory Officer, Medtronic
- Emer Sherry - Senior Executive, Irish Medtech
11:00 – FDA Submissions, Untitled Letters, AI Use, and Best Practice – Trinzo
- Liam Turley - CEO, Trinzo
- Conor Flynn - Head of Innovation, Trinzo
11:30 – Networking tea and coffee break
11:45 – Notified Body Update - TÜV Rheinland
- Maciej Sciera - Global Scheme Manager ISO 13485 and MDR
- Paul Kowalski - Field Sales Executive
12:35 – Notified Body Interactions and Labelling Taskforce Update
- Elizabeth Delahunty – Associate Director Regulatory Affairs, BD Enniscorthy
- Eileen Looby – Senior Regulatory Affairs Manager, Abbott
- Bernadette Griffin - Regulatory Affairs Manager, Mylan Teoranta (Viatris)
- Tara Cox - Head of Device Quality and Regulatory Compliance, Takeda
13:00 – Networking lunch
14:00 – Global Regulatory Taskforce Update – Russian Audit
- Ian Phillips – Associate Director Regulatory Affairs, Boston Scientific
- Nora Armstrong – Principal Regulatory Affairs Specialist, Styker
- Una Barry - Principal Regulatory Affairs Specialist, Stryker
- Linda O’Connor – Senior Regulatory Affairs Manager, Medtronic
- Nicole O’Shea – Regulatory Affairs Specialist, Medtronic
14:25 – Digital Health Taskforce Update - MDR/IVDR Proposal in Relation to the AI Act
- Niamh St John Lynch - PhD Researcher of AI-enabled MDs, Regs and Standards, & Lecturer Software Validation -DkIT
14:50 – Irish Medtech Skillnet Update
- Dr Ann O’Connell - Head of Funded Projects for Medtech and Engineering at Ibec and Network Manager for Irish Medtech Skillnet
15:20 – Closing remarks
- Emer Sherry - Senior Executive, Irish Medtech