• Donal O’Connor, Clinical Manager, Health Products Regulatory Authority (HPRA)

• Greg Le Blanc, Director, Regulatory Affairs and Quality Systems, Cook Medical, Canada

Orphan and humanitarian-use medical devices

• Donal O’Connor, Clinical Manager, Health Products Regulatory Authority (HPRA)
• Tetsuya Kusakabe, Director of Office of Manufacturing Quality and Vigilance for Medical Devices, International Coordination Officer Pharmaceuticals and Medical Devices Agency (PMDA) 
• Leo Hovestadt, EU Director Governmental Affairs, Elekta
• Cho Ahram, Deputy Director, Ministry of Food and Drug Safety (MFDS), South Korea
• April Veoukas, Director Regulatory Affairs, Abbott

Paediatric medical devices 

• Kenneth Cavanaugh, Deputy Office Director, U.S Food and Drugs Administration (FDA)
  
• Joel Batts, Senior Vice President of Clinical & Regulatory Affairs, OrthoPaediatrics
• Berthold Koletzko,  Professor of Paediatrics, LMU University Hospitals

Personalized and custom medical devices

• Tracey Duffy, First Assistant Secretary, Medical Devices and Product Quality Division, TGA
• Mariana Madureira, Senior Officer, Health Products Directorate, INFARMED
• Jan Demol, Regulatory Affairs Manager, Materialise
• Matthias Neumann, Deputy Head Medical Devices Safety Unit, German Federal Ministry of Health
• Christophe Carrein, Director Quality & Compliance, Velsera

Existing pathways for innovative medical devices

• Erin Cutts, Senior International Policy Analyst, FDA
  
• Sally Prawdzik, Acting Director, Policy and International Programs, Health Canada
• Woei Jiuang Wong, Assistant Group Director of Medical Devices Cluster, Health Products Regulation Group, Health Sciences Authority (HSA)
• Joao Martins, Associate Director Regulatory Affairs Strategy, Abbott
• Yujin Lee, Chief Medical Officer, WELT Corp
• Nataliya Deych, Vice President Regulatory Affairs (EMEACLA), Edwards Lifesciences
• Helmut Scherer, Chief Technology Officer, Erbe Elektromedizin

Opportunities for convergence and reliance

• Augusto Bencke Geyer, General Manager, General Management of Health Product Technology, ANVISA
• Yasha Huang, Head of Regulatory Policy Asia Pacific, Roche Diagnostics
• Johanna Sorsa, Senior Manager Clinical and Regulatory Affairs, Siemens Healthineers
• Latifa Lakehal, Head of Standards and Regulations, Philips
• Diane Wurzburger, Executive Regulatory Affairs & Quality, Developed Markets & Global Strategic Policy, GE Healthcare

• Regulatory sandboxes
  • Paul Campbell, Innovative Devices at the Medicines and Healthcare products Regulatory Agency (MHRA)
  • Nada Alkhayat, Policy Officer, Directorate General for Health and Food Safety, European Commission
  • Koen Cobbaert, Senior Manager - Quality, Standards & Regulations, Philips
  • Bettina Möbius, Director Regulatory Affairs, Dräger
• Predetermined change controls and innovative tools in the regulatory toolbox
  • Yuang Peng, Division Director, Department of Medical Device Registration, National Medical Products Administration (NMPA)
  • Russell Pearson, AI Regulation and Policy Specialist, Innovative Devices at the Medicines and Healthcare products Regulatory Agency (MHRA)
  • Cassie Scherer, Senior Director, Digital Health Policy & Regulatory Strategy, Medtronic
  • April Veoukas, Director Regulatory Affairs, Abbott
  • Anna Hallersten, Head Regulatory Policy Europe, Roche Diagnostics

• Australia - Tracey Duffy, First Assistant Secretary, Medical Devices and Product Quality Division, TGA
• Brazil - Augusto Bencke Geyer, General Manager, General Management of Health Product Technology, ANVISA
• Canada - Sally Prawdzik, Acting Director, Policy and International Programs, Health Canada
• China - Yuan Peng, Division Director, Department of Medical Device Registration, NMPA
• European Union - Nada Alkhayat, Policy Officer, Directorate General for Health and Food Safety, European Commission & Chloe Spathari, Policy Officer, Directorate General for Health and Food Safety, European Commission

• Japan - Tomoyuki Miyasaka, Deputy Director, Medical Devices Evaluation Division, MHLW
• Singapore - Wong Woei Jiuang, Assistant Group Director, Medical Devices Cluster, HSA
• South Korea - Jeong-Rim Lee, Director General, Medical Device Evaluation Department, MFDS
• United Kingdom - Laura Squire, Chief Healthcare Quality and Access Office, Medicines and Healthcare products Regulatory Agency (MHRA)
• United States of America - Kenneth Cavanaugh, Deputy Director, Office of Cardiovascular Devices, US FDA

Official observers:

• Argentina - Yesica Anastasio, Coordinator of the International Relations Program, National Administration of Drugs, Food and Medical Devices (ANMAT)
• Switzerland - Markus Wälti, Head of Division, Swiss Agency for Therapeutic Products (Swissmedic)
• World Health Organization (WHO) - Hiiti Baran Sillo, Unit Head, Regulation and Safety Department of Regulation and Prequalification

• African Medical Devices Forum (AMDF) - Paulyne Wairimu, Chair
• Asia Pacific Economic Cooperation (APEC) - Cheng-Ning (Emily) Wu, Senior Technical Specialist, Division of Medical Devices and Cosmetics, Taiwan Food and Drug Administration
• Global Harmonization Working Party (GHWP) -  Bryan So, Executive Secretary General
• The Global Diagnostic Imaging, Healthcare ICT, and Radiation Therapy Trade Association (DITTA) - Patrick Hope, Chair
• Global Medical Technology Alliance (GMTA) - Diana Kanecka, Senior Manager International Affairs, MedTech Europe

The aim of this information session is to explain the EU Medical Devices Regulation (MDR) amendment adopted in March 2023 (Regulation (EU) 2023/607) and discuss its practical implementation from different angles.