Registration & Morning Networking

7:30-9:00 AM

Welcome address by IMDRF Chair

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

9:00-9:05 AM

Welcome address by US FDA

• Robert M. Califf, Commissioner, US FDA 

9:05-9:15 AM

Welcome address by Industry

• Janet Trunzo, Chair; Global Medical Technology Alliance (GMTA)

9:15-9:25 AM

Perspective from WHO 

• Hiiti Sillo, Unit Head, Regulation and Safety, Regulation and Prequalification Department, World Health Organization (WHO)  

9:25-9:40 AM

Perspective from Industry 

• Nicole Taylor Smith, Philips

9:40-9:55 AM

Panel Discussion 

• Chloe Spathari, EU
• Woei Jiuang, HSA
• Lorena Terrizzano, ANMAT
• Paulyne Wairimu, Chair, African Medical Devices Forum (AMDF); Head, Medical Devices and In-Vitro Diagnostics, Health Products and Technologies, Pharmacy and Poisons Board (PPB)
• Nilda Enriquez, PAHO
• Hiiti Sillo, Unit Head, Regulation and Safety, Regulation and Prequalification Department, World Health Organization (WHO)  
• Nicole Taylor Smith, Philips
• Tracey Duffy, TGA
• Fatemeh Razjouyan, Medtronic

9:55-10:35 AM 

Overview of enabling conditions

• Augusto Geyer, Regulatory Specialist; ANVISA

11:00 AM-11:15 AM 

Panel Discussion

• Augusto Geyer, Regulatory Specialist; ANVISA
• María Cecilia López, Head of Medical Devices Registration Office; Public Health Institute of Chile (ISP)
• Fikru D. Bulto, Regulatory Specialist; Ethiopian Food and Drug Administration (EFDA)
• Shang-Ching Lin, Associate Researcher; Taiwan Food and Drug Administration (TFDA) 
• Miang Tanakasemsub, Regional Regulatory Affairs head APJ Vision, Johnson & Johnson Medtech, GHWP TC Vice Chair & APACMED RA committee Chair
• Sunny Woo, Team Leader, International Affairs Team; Korea Medical Devices Industry Association (KMDIA)
• Duglas Calderon, Global Head of LATAM Regulatory Policy. Global Regulatory Policy and Intelligence; Roche Diagnostics
• Sally Prawdzik, Acting Director, Policy and International Programs, Medical Devices Directorate, Health Canada 
• Maurizio Andreano, Sen. Director Technical Regulations & Standardization; Siemens Healthineers

11:15 AM-12:30 PM

Reliance and recognition

• Diane Wurzburger, VP Regulatory, Quality & Global Policy, GE HealthCare 

1:30-1:40 PM  

Publication of law, including definitions, and regulations with transition period

• Emmanuel Emori Armon, Deputy Director, National Agency for Food and Drug Administration and Control (NAFDAC)

1:40-1:50 PM  

Basic level controls and enforcement – premarket and placing on the market

• Mario Vega, Head of Medical Devices Registration Unit, National Directorate of Medicines (DNM)

1:50-2:05 PM  

Basic level controls and enforcement - postmarket

• Paulyne Wairimu, Chair, African Medical Devices Forum (AMDF); Head, Medical Devices and In-Vitro Diagnostics, Health Products and Technologies, Pharmacy and Poisons Board (PPB)

2:05-2:15 PM  

Expanded-level controls- premarket and placing on the market

• Ahram Cho, Deputy Director, Medical Devices Policy Division, Ministry of Food and Drug Safety (MFDS)

2:15-2:30 PM  

Expanded level controls- postmarket

• Koko Nakamichi, NCAR Secretariat, Pharmaceuticals and Medical Devices Agency (PMDA)

2:30-2:40 PM  

Tools and methods to support a robust medical device regulatory system

• Andrew Fish, President & CEO, Medical Device Innovation Consortium (MDIC)

2:40-2:50 PM  

Panel Discussion

• Diane Wurzburger, GE Healthcare 
• Emmanuel Emori Armon, Deputy Director, National Agency for Food and Drug Administration and Control (NAFDAC) 
• Mario Vega, Head of Medical Devices Registration Unit, National Directorate of Medicines (DNM) 
• Paulyne Wairimu, Chair, African Medical Devices Forum (AMDF); Head, Medical Devices and In-Vitro Diagnostics, Health Products and Technologies, Pharmacy and Poisons Board (PPB)
• Ahram Cho, Deputy Director, Medical Devices Policy Division, Ministry of Food and Drug Safety (MFDS) 
• Koko Nakamichi, NCAR Secretariat, Pharmaceuticals and Medical Devices Agency (PMDA) 

• Andrew Fish, President & CEO, MDIC 

Moderators:

• Laura Squire, Med Tech Regulatory Reform Lead, Chief Healthcare Quality and Access Officer, Medicines and Healthcare Products Regulatory Agency (MHRA) 
• Greg LeBlanc, Director, Regulatory Affairs and Quality Systems, Cook (Canada) Inc. / Cook Medical 

2:50-3:35 PM

Panel Discussion

• TBD, China National Medical Products Administration (NMPA)
• Andre Breisinger, Medical Devices Regulation Expert, Swissmedic
• TBD, Tanzania Medicines and Medical Devices Authority (TMDA)
• Shang-Ching Lin, Associate Research, Taiwan Food and Drug Administration, on behalf of Asia-Pacific Economic Cooperation (APEC)
• Hiiti Sillo, Unit Head, Regulation and Safety, Regulation and Prequalification Department, World Health Organization (WHO)
• Naoki Morooka, Senior General Manager, Medical Regulatory Policy Department, Shimadzu Corporation
• Raina Dauria, Vice President, Global Regulatory Policy, Johnson & Johnson MedTech
• Kenneth Cavanaugh, Center for Devices and Radiological Health, US FDA
• Olga van Grol-Lawlor, Senior Global Regulatory Intelligence & Advocacy Manager, Boston Scientific

4:00-4:50 PM

Summary 

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

4:50- 5:00 PM

Registration

8:30 to 9:00 AM

Welcome

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

9:00 to 9:05 AM

Australia

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

9:05 to 9:15 AM

Brazil

• Augusto Geyer, Regulatory Specialist, ANVISA

9:15 to 9:25 AM

Canada

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

9:25 to 9:35 AM

China

• Wen Gao, Consultant, NMPA

9:35 to 9:45 AM

EU

• Nada Alkhayat, Policy Officer, European Commission

9:45 to 9:55 AM

Japan

• Eriko Fukuda, International Coordination Officer, PMDA

9:55 to 10:05 AM

Q&A for Previous Speakers

10:05 to 10:20 AM

Singapore 

• Lai Peng Low, Deputy Director, Therapeutic Devices Branch, HSA

10:45 to 10:55 AM 

South Korea 

• Hye-Won Roh, Director General, Medical Devices Evaluation Department, MFDS

10:55 to 11:05 AM 

United Kingdom

• Joseph Burt, Head of IVD and General Medical Devices, MHRA

11:05 to 11:15 AM

United States of America 

• Melissa Torres, Associate Director for International Affairs, Center for Devices and Radiological Health, U.S. FDA

11:15 AM to 11:25 AM

Argentina (Official Observer)

• Lorena Terrizano, National Director of the National Institute of Medical Devices, ANMAT

11:25 to 11:35 AM

Switzerland (Official Observer)

• Markus Wälti, Head of Division Medical Devices Vigilance, Swissmedic

11:35 to 11:45 AM

World Health Organization (Official Observer)

• Irena Prat, Team Lead, WHO

11:45 to 11:55 AM

Q&A for Previous Speakers

11:55 AM to 12:10 PM

WG Updates 

• Secretariat

12:15 PM to 12:25 PM

Good Regulatory Review Practices (U.S./Singapore)

• Lai Peng Low, Deputy Director, Therapeutic Devices Branch, HSA

12:25 to 12:35 PM

Clinical Evidence for IVDs (E.U./U.K.)

• Annie Truong, Diagnostics Lead, MHRA

12:35 to 12:45 PM

Q&A

12:45-1:00 PM

• Miriam Boles, Head of the Central Administration of Medical Devices (CAMD), and Sondos Moshtohry, Head of the Administration for Cooperation with International Organizations, Egyptian Drug Authority (EDA)
• Dr. Dimakatso Mathibe, Senior Manager, Medical Device and Radiation Control, South African Health Product Regulatory Authority (SAHPRA) and Vice Chair, Africa Medical Devices Forum (AMDF)
• Mira Kontić, Deputy Managing Director, and Dr. pharm Maja Petrović, Medical Device Registration Expert, Institute for Medicines and Medical Devices of Montenegro (CInMED)
• Michelle Noonan, International Policy Analyst, Center for Devices and Radiological Health (CDRH), U.S. FDA

2:00 to 2:30 PM

Q&A

2:30-2:45 PM

• Shang-Ching Lin, Associate Researcher, TFDA
• Paulyne Warimu, Chair African Medical Devices Forum and Medical Devices and Diagnostics Lead, Pharmacy and Poisons Board, Kenya
• Miang Tanakasemsub, Vice Chair, GHWP & Regional Regulatory Affairs Head, JNJ Vision
• Alfonso Rosales, Pan American Health Organization

• Neil Mafnas, CDR, USPHS, Senior Program Management Officer, Center for Devices and Radiological Health, U.S. FDA

2:55 to 3:20 PM 

Q&A

3:20-3:35 PM

• Naoki Morooka, Senior General Manager of Medical Regulatory Policy; Shimadzu Corporation
• Robert Z. Phillips, Head of Quality & Regulatory – North America, Siemens Healthineers
• Mia Spiegelmann, Vice President, Regulatory Affairs, MedTech Canada
• Jasjit Baveja, Associate Director, Policy, Medical Technology of Australia (MTAA)
• Diana Kanecka, Senior Manager International Affairs, MedTech Europe
• Stephen Lee, Director, Diagnostics and Digital Regulation; Association of British HealthTech Industries (ABHI)

• Melissa Torres, Associate Director for International Affairs, Center for Devices and Radiological Health, U.S. FDA
• Janet Trunzo, Chair, Global Medical Technology Alliance (GMTA)

4:00 to 4:40 PM

Closing Remarks

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

4:40 to 4:45 PM