IMDRF 2023

24th session

25-26 September 2023 | Berlin, Germany


Andrzej Ryś
Principal Scientific Adviser, Directorate-General for Health and Food Safety, European Commission
Edgar Franke
Parliamentary State Secretary to the Federal Minister of Health, Germany
Nada Alkhayat
Policy Officer, Directorate General for Health and Food Safety, European Commission
Yesica Anastasio
Coordinator of the International Relations Program at the National Administration of Drugs, Food and Medical Devices (ANMAT)
Abdullatif S. AlWatban
Technical Committee Chair, Global Harmonization Working Party (GHWP)
Joel Batts
Senior Vice President of Clinical & Regulatory Affairs, OrthoPaediatrics
Augusto Bencke Geyer
Head of Medical Devices Office, Brazilian Health Regulatory Agency
Dennis Black
UDI Programme Director, BD
Steffen Buchholz
Paul Campbell
Innovative Devices at the Medicines and Healthcare products Regulatory Agency (MHRA)
Christophe Carrein
Director Quality & Compliance, Velsera
Kenneth J. Cavanaugh
Deputy Office Director, U.S. Food and Drug Administration
Chae Gyu-Han
Director General, Medical Devices Policy Division, Medical Devices Safety Bureau, MFDS
Cho Ahram
Deputy Director, Ministry of Food and Drug Safety (MFDS), South Korea
Koen Cobbaert
Senior Manager - Quality, Standards & Regulations, Philips
Erin Cutts
Senior international policy analyst, U.S. Food and Drug Administration
Orla Daly
Legal and Policy Officer, Directorate General for Health and Food Safety, European Commission
Jan Demol
Regulatory Affairs Manager, Materialise
Nataliya Deych
Vice President Regulatory Affairs (EMEACLA), Edwards Lifesciences
Tracey Duffy
First Assistant Secretary of the Medical Devices and Product Quality Division, Therapeutic Goods Administration, Australia
Anna Hallersten
Head Regulatory Policy Europe, Roche Diagnostics
Patrick Hope
Chair, Global Diagnostic imaging, healthcare IT & radiotion Therapy Trade Association (DITTA) and Executive Director, Medical Imaging & Technology Alliance (MITA)
Leo Hovestadt
EU Director Governmental Affairs, Elekta
Yasha Huang
Head of Regulatory Policy Asia Pacific, Global Regulatory Policy & Intelligence, Roche Diagnostics
Xu Jinghe
Deputy Commissioner, National Medical Products Administration (NMPA), GHWP Chair
Diana Kanecka
Senior Manager International Affairs, MedTech Europe
Ittipan Kanluan
Regulatory Affairs Manager, Roche Diagnostics
Berthold Koletzko
Professor of Paediatrics, LMU University Hospitals
Tetsuya Kusakabe
Director of Office of Manufacturing Quality and Vigilance for Medical Devices, International Coordination Officer Pharmaceuticals and Medical Devices Agency (PMDA)
Latifa Lakehal
Head of Standards and Regulations Europe, Philips
Greg LeBlanc
Director, Regulatory Affairs and Quality Systems, Cook Medical, Canada
Lee Chung-Keun
Ministry of Food and Drug Safety, South Korea
Yujin Lee
Chief Medical Officer, WELT Corp
Jeong Rim Lee
Director General of Medical Device Evaluation Department, Ministry of Food and Drug Safety, Republic of Korea
Alexandre Lemgruber
Regional Advisor on Health Technologies Management, Pan American Health Organization
Lim Jin Hwan
Niall MacAleenan
Director of Medical Devices, Health Products Regulatory Authority (HPRA)
Mariana Madureira
Senior Officer, Health Products Directorate, INFARMED
João Martins
PharmD, Associate Director, Regulatory Strategy, Abbot
Tomoyuki Miyasaka
Deputy Director, Medical Devices Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare (MHLW), Japan
Dr. Bettina Möbius
Director Central Regulatory & Clinical Affairs, Drägerwerk AG & Co. KGaA
Matthias Neumann
Deputy Head Medical Devices Safety Unit, German Federal Ministry of Health
Donal O’Connor
Clinical Manager, Health Products Regulatory Authority (HPRA)
Rolf Oberlin Hansen
International Representative, Danish Medicines Agency
Silvia Ostuni
Legal and Policy Officer, Directorate General for Health and Food Safety, European Commission
Tania Pearson
Regulatory Systems Director, Medtronic
Russell Pearson
AI Regulation and Policy Specialist, Innovative Devices at the Medicines and Healthcare products Regulatory Agency (MHRA)
Yuan Peng
Division Director, Department of Medical Device Registration, NMPA
Irena Prat
Team Lead, In vitro diagnostics Assessment, World Health Organization
Sally Prawdzik
Acting Director, Policy and International Programs, Health Canada
Jesús Rueda Rodríguez
Director General Strategies, Special Projects and International Affairs, MedTech Europe
Tobias Schreiegg
Director Regulatory Affairs, Siemens Healthineers
Cassie Scherer
Senior Director, Digital Health Policy & Regulatory Strategy, Medtronic
Helmut Scherer
Chief Technology Officer, Erbe Elektromedizin
Hiiti Baran Sillo
Unit Head, Regulation and Safety Department of Regulation and Prequalification, World Health Organization (WHO)
Bryan So
Executive Secretary General , Global Harmonization Working Party
Johanna Sorsa
Senior Manager Clinical and Regulatory Affairs, Siemens Healthineers
Chloe Spathari
Policy Officer, European Commission’s Unit for Medical Devices in the Directorate General for Health and Food Safety
Laura Squire
Chief Healthcare Quality and Access Office, Medicines and Healthcare products Regulatory Agency (MHRA)
Tang Jinglong
Melissa Torres
Associate Director for International Affairs, Center for Devices and Radiological Health, U.S. Food and Drug Administration
Janet Trunzo
Chair, Global Medical Technology Alliance ( GMTA)
April Veoukas
Director Regulatory Affairs, Abbott
Paulyne Wairimu
Chair, African Medical Devices Forum (AMDF)
Markus Wälti
Head of Division Medical Devices Vigilance in Market Surveillance, Swissmedic
Woei Jiuang Wong
Assistant Group Director of Medical Devices Cluster, Health Products Regulation Group, Health Sciences Authority (HSA)
Cheng-Ning Wu
Senior Technical Specialist, Division of Medical Devices and Cosmetics, Taiwan Food and Drug Administration
Diane Wurzburger
Executive Regulatory Affairs & Quality, Developed Markets & Global Strategic Policy, GE Healthcare