AGENDA

Virtual attendance will be offered on Day 1 & Day 2 only.

DAY 1 AGENDA - MONDAY, MARCH 11, 2024

Day 1 - Joint IMDRF/ Industry Workshop on Reliance
7:30 AM - 8:30 AM
Foyer
 
8:00 AM - 8:30 AM
Foyer
 
8:30 AM - 9:00 AM
Amphitheater

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 RodríguezDirector General Strategies, Special Projects and International Affairs, MedTech Europe

8:50-9:00 AM

 

9:00 AM - 9:40 AM
Amphitheater

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

9:40 AM - 10:05 AM
Foyer
 
10:05 AM - 12:20 PM
Amphitheater

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 

12:20 PM - 1:30 PM
Foyer
 
1:30 PM - 3:45 PM
Amphitheater

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 

 

3:45 PM - 4:10 PM
Foyer
 
4:10 PM - 4:50 PM
Amphitheater

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

4:50 PM - 5:00 PM
Amphitheater

Summary 

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

4:50- 5:00 PM

5:30 PM - 7:00 PM
555 13th ST NW, Washington, DC

   

The reception will take place across the street from the meeting venue at 555 13th ST NW.  Please bring your IMDRF meeting badge to gain entry to the building.  The Secretariat and reception hosts will be available onsite to assist with directions and escort you to the reception.  Please note that this event is not open to the press. 

 

Time Zone: (UTC-04:00) Eastern Time (US & Canada) [Change Time Zone]

DAY 2 AGENDA - TUESDAY, MARCH 12, 2024

Day 2 - IMDRF Stakeholder Forum
8:30 AM - 9:00 AM
Foyer
 
9:00 AM - 9:10 AM
Amphitheater

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

9:10 AM - 10:35 AM
Amphitheater

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

10:35 AM - 11:00 AM
Foyer
 
11:00 AM - 11:50 AM
Amphitheater

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

12:00 PM - 12:30 PM
Amphitheater

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

12:30 PM - 2:00 PM
Foyer
 
2:00 PM - 2:50 PM
Amphitheater
  • 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

3:00 PM - 3:45 PM
Amphitheater
  • 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

3:45 PM - 4:10 PM
Foyer
 
4:10 PM - 4:55 PM
Amphitheater
  • 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

4:55 PM - 5:00 PM
Amphitheater

Closing Remarks

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

4:55 to 5:00 PM

Time Zone: (UTC-04:00) Eastern Time (US & Canada) [Change Time Zone]