Welcome address by the U.S. FDA

• Robert Califf, Commissioner

8:30-8:45 AM

Welcome address by the IMDRF 2024 Chair

• Jeff Shuren, Director, Center for Devices and Radiological Health, US FDA

8:45- 8:50 AM

Welcome address by Industry 

• Masaaki Ohtsuka, DITTA Vice-Chair and JIRA Secretary General
• Jesús Rueda Rodríguez, Director General Strategies, Special Projects and International Affairs, MedTech Europe

8:50-9:00 AM

Status of reliance 

• Diane Würzburger, Executive Regulatory Affairs & Quality, Developed Markets & Global Strategic Policy, GE Healthcare

9:00-9:20 AM

The role of standards

• Kuniki Imagawa, Deputy Division Director, Pharmaceuticals and Medical Devices Agency, PMDA Japan

9:20-9:30 AM

A perspective from WHO

• Hiiti Baran Sillo, Unit Head, Regulation and Safety, WHO

9:30-9:40 AM

Case studies in premarket reliance implementation 

• Tracey Duffy, First Assistant Secretary, Medical Devices and Product Quality Division, TGA Australia
• Woei Jiuang Wong, Asst Group Director, HSA Singapore
• Maria Luz Pombo-Castro, Unit Chief, for Quality and Regulations of Medicines and Health Technologies (IMT/QR), PAHO
• Nada Alkhayat, Policy Officer, European Commission
• Naomi Morioka, General Manager of Medication Regulatory Policy Department, Shimadzu Corporation
• Mario Cesar Muñiz Ferrer, Head of Medical Devices Department, CECMED
• Tammy Steuerwald, Global Head of Regulatory Policy, Foundational Principles of Supranational Organizations, Roche Diagnostics

10:05 AM-11:35 AM 

Panel Discussion

• Chloe Spathari, Policy Officer, European Commission
• Maurizio Andreano, Senior Director - Head of Technical Regulations & Standardization, Siemens Healthineers

11:35 AM-12:20 PM 

Case studies in post market reliance implementation 

• Ana Carolina M Marino Araujo, Senior Advisor, ANVISA Brazil
• Mariela Aranda, Head of In Vitro Diagnostic Medical Device Office, ANMAT Argentina
• Anat Boehm-Cagan, Head of Medical Technologies Regulation and Regulatory Partnerships, MTIIR Israel
• Chloe Spathari, Policy Officer, European Commission
• Ching-Wei Chang, Section Chief, Taiwan Food and Drug Administration
• Tracey Duffy, First Assistant Secretary, Medical Devices and Product Quality Division, TGA Australia
• Philippe Auclair, Senior Director Regulatory Strategy, Abbott
• Leo Hovestadt, Director Governmental Affairs EU, Elekta

1:30-3:00 PM  

Panel Discussion

• Sally Prawdzik, Acting Director, Bureau of Policy and International Programs, Health Canada
• Phil Brown, Director, Regulatory and Compliance, ABHI

3:00-3:45 PM 

Panel Discussion  

• Augusto Geyer, Head of Medical Devices Office, ANVISA
• Markus Wälti, Head of Division Medical Devices Vigilance in Medical Devices Surveillance, Swissmedic, Swiss Agency for Therapeutic Products 
• Maria Cecilia López, Head of Medical Devices Registration Subdepartment, ISP, Chile
• Paulyne Wairimu, Medical Devices and Diagnostics Lead, Pharmacy and Poisons Board, Kenya; Chair, African Medical Devices Forum
• Nicole Taylor Smith, Global Head of Regulatory Science and Policy, Philips
• Fatemeh Razjouyan, Director of Regulatory Policy, International and Harmonization, Medtronic
• Eve Hutchinson, Head of Regulation in the Innovative Devices team, MHRA
• Jesús Rueda Rodríguez, Director General Strategies, Special Projects and International Affairs, MedTech Europe

4:10-4:50 PM

Summary 

• Jeff Shuren, Chair, IMDRF2024; Director, Center for Devices and Radiological Health, US FDA

4:50- 5:00 PM

Welcome

• Jeff Shuren, Chair, IMDRF2024; Director, Center for Devices and Radiological Health, U.S. FDA
• Mark Abdoo, Associate Commissioner for Global Policy and Strategy, U.S. FDA

9:00 to 9:10 AM

Australia

• Tracey Duffy, First Assistant Secretary, Medical Devices and Product Quality Division, TGA

9:10 to 9:20 AM

Brazil

• Augusto Geyer, General Manager, Office of Medical Devices, ANVISA

9:20 to 9:30 AM

Canada

• Bruce Randall, Director General, Medical Devices Directorate, Health Canada

9:30 to 9:40 AM

China

• Yuan Peng, Director, Medical Device Registration Department, NMPA

9:40 to 9:50 AM

EU

• Nada Alkhayat, Policy Officer, European Commission

9:50 to 10:00 AM

Japan

• Miyasaka Tomoyuki, Deputy Director, Medical Device Evaluation Division, Pharmaceutical Safety Bureau, MHLW

10:00 to 10:10 AM

Singapore

• Woei Jiuang Wong, Asst Group Director, HSA
• Alvin Lee, Deputy Director, Aged & Ancillary Service Regulations & Transformation Division, Health Regulation Group, Ministry of Health

10:10 to 10:25 AM

South Korea

• Ahram Cho, Deputy Director, Medical Devices Policy Division, MFDS

10:25 to 10:35 AM

United Kingdom

• Laura Squire, Chief Healthcare Quality and Access Officer, MHRA

11:00 to 11:10 AM

United States of America 

• Melissa Torres, Associate Director for International Affairs, U.S. FDA

11:10 AM to 11:20 AM

Argentina (Official Observer)

• Mariela Aranda, Head of the Service of In Vitro Diagnostic Products, ANMAT 

11:20 to 11:30 AM

Switzerland (Official Observer)

• André Breisinger, Expert Medical Devices Regulation, Medical Devices Surveillance, Swissmedic

11:30 to 11:40 AM

World Health Organization (Official Observer)

• Irena Prat, Team Lead, In Vitro Diagnostics Assessment, Prequalification Unit, WHO

11:40 to 11:50 AM

WG Updates 

Secretariat

12:00 PM to 12:10 PM

Software as a Medical Device (SaMD) Working Group- IMDRF/SAMD WG/N81 (U.S./Canada)

• MiRa Jacobs, Division Director, Division of Digital Health Policy, U.S. FDA

12:10 to 12:20 PM

Regulated Product Submission Working Group- IMDRF/RPS WG/N9 and IMDRF/RPS WG/N13 (Canada/U.S.)

• Daniel Yoon, Regulatory Advisor, Health Canada

12:20 to 12:30 PM

• Anat Boehm-Cagan, Head of Regulatory Strategy and Partnerships, Israel Ministry of Health
• Maria Cecilia López, Head of Medical Devices Registration Office, Public Health Institute of Chile (ISP)
• Ching-Wei Chang, Section Chief, Taiwan Food and Drug Administration
• Mario Cesar Muñiz Ferrer, Head of Medical Devices Department, CECMED
• Michelle Noonan, International Policy Analyst, U.S. FDA
• Ana Patricia Pineda, International Regulatory Analyst, U.S. FDA

2:00 to 2:50 PM

• Paulyne Wairimu, Chair, AMDF; Medical Devices and Diagnostics Lead, PPB
• Ching-Wei Chang, APEC; Section Chief, Taiwan Food and Drug Administration
• Alexandre Lemgruber, Unit Chief AI, Access to Medicines and Health Technologies, PAHO
• Global Harmonization Working Party

• Neil Mafnas, Senior Project Management Officer, U.S. FDA

3:00 to 3:45 PM

• Chidae Park, RA Managing Director, Lutronic Corporation
• Raina Dauria, VP, Global Regulatory Policy, MedTech, Johnson & Johnson
• Olga Van Grol-Lawlor, Senior Global Regulatory Intelligence & Advocacy Manager, Boston Scientific
• Naoki Morooka, Senior General Manager of Medical Regulatory Policy, Shimadzu Corporation
• Diane Würzburger, VP Regulatory Affairs, Quality & Global Policy, GE Healthcare
• Rumi Young, Director, Regulatory Policy, Becton Dickinson

• Maurizio Andreano, VP Technical Standardization, Siemens Healthineers
• Greg LeBlanc, Director, Regulatory Affairs and Quality Systems, Cook Medical

4:10 to 4:55 PM

Closing Remarks

• Jeff Shuren, Chair, IMDRF2024; Director, Center for Devices and Radiological Health, U.S. FDA

4:55 to 5:00 PM