IMDRF 2023

24th session

25-26 September 2023 | Berlin, Germany

Agenda

Timezone:

Day 1 - 25 September 2023

Joint IMDRF / Stakeholder (DITTA-GMTA) Workshop - Specialized Regulatory Pathways

08:00 - 08:30

Registration and welcome coffee

08:30 - 08:45

Opening remarks

  • Andrzej Rys, Chair EU2023, IMDRF
  • Annabel Seebohm, Vice-Chair, Global Diagnostic imaging, healthcare IT & radiation Therapy Trade Association (DITTA)
  • Jesus Rueda Rodriguez, Co-Chair, Global Medical Technology Alliance (GMTA)
08:45 - 09:05

Overview of IMDRF foundational pathways

  • Greg Le Blanc, Director, Regulatory Affairs and Quality Systems, Cook Medical, Canada
09:05 - 10:10

Devices intended for specific patient populations

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
10:10 - 10:35

Coffee break

10:35 - 11:15

Devices intended for specific patient populations

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
11:15 - 11:40

Devices intended for specific patient populations

Panel discussion – lessons learned and opportunities for improvement

Moderators: Janet Trunzo, Chair, Global Medical Technology Alliance (GMTA) & Matthias Neumann, European Commission

  • 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)
  • Kenneth Cavanaugh, Deputy Office Director, U.S Food and Drugs Administration (FDA)
  • Leo Hovestadt, EU Director Governmental Affairs, Elekta
  • Joel Batts, Senior Vice President of Clinical & Regulatory Affairs, OrthoPaediatrics
  • Tracey Duffy, First Assistant Secretary, Medical Devices and Product Quality Division, TGA
  • Jan Demol, Regulatory Affairs Manager, Materialise
11:40 - 13:20

Innovative medical devices

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
13:20 - 14:20

Lunch break

14:20 - 14:45

Innovative medical devices

Panel discussion – lessons learned and opportunities for improvement

Moderators: Diane Wurzburger, GE Healthcare & Steffen Buchholz, DE – EU

  • Sally Prawdzik, Acting Director, Policy and International Programs, Health Canada
  • Erin Cutts, Senior International Policy Analyst, FDA
  • Joao Martins, Associate Director Regulatory Affairs Strategy, Abbott
  • Yujin Lee, Chief Medical Officer, WELT Corp
  • Augusto Bencke Geyer, General Manager, General Management of Health Product Technology, ANVISA
  • Johanna Sorsa, Senior Manager Clinical and Regulatory Affairs, Siemens Healthineers
14:45 - 16:00

Regulatory toolboxes to foster innovation

  • 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
16:00 - 16:25

Regulatory toolboxes to foster innovation

Panel discussion – lessons learned and opportunities for improvement

Moderators: Jesus Rueda, Global Medical Technology Alliance (GMTA) & Rolf Oberlin Hansen, International Representative, Danish Medicines Agency

  • Russell Pearson, AI Regulation and Policy Specialist, Innovative Devices at the Medicines and Healthcare products Regulatory Agency (MHRA)
  • Koen Cobbaert, Senior Manager - Quality, Standards & Regulations, Philips
  • Yuang Peng, Division Director, Department of Medical Device Registration, National Medical Products Administration (NMPA)
  • Paul Campbell, Innovative Devices at the Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Cassie Scherer, Senior Director, Digital Health Policy & Regulatory Strategy, Medtronic
  • Anna Hallersten, Head Regulatory Policy Europe, Roche Diagnostics
16:25 - 16:30

Closing remarks

16:30 - 18:00

Cocktail reception