IMDRF 26th Session  |  September 16-20, 2024  |  Seattle, Washington

 

AGENDA

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

***PLEASE NOTE: ALL TIMES ARE PACIFIC TIMES**

DAY 1 AGENDA - MONDAY, SEPTEMBER 16, 2024

Day 1 - Joint IMDRF/ Industry Workshop on Developing a Medical Device Regulatory System
7:30 AM - 9:00 AM
Registration
7:30 AM - 9:00 AM

Registration & Morning Networking

7:30-9:00 AM

8:30 AM - 9:00 AM
Morning Networking
8:30 AM - 9:00 AM
 
9:00 AM - 9:25 AM
Opening Remarks
9:00 AM - 9:25 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

9:25 AM - 10:35 AM
Scene Setting: Different paths to developing a regulatory system
9:25 AM - 10:35 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 

10:35 AM - 11:00 AM
Break
10:35 AM - 11:00 AM
 
11:00 AM - 12:30 PM
Session 1: Enabling Conditions for Effective Regulation of Medical Devices
11:00 AM - 12:30 PM

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

12:30 PM - 1:30 PM
Lunch Break
12:30 PM - 1:30 PM
 
1:30 PM - 3:35 PM
Session 2: Stepwise Approach to Regulating Medical Devices
1:30 PM - 3:35 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

3:35 PM - 4:00 PM
Break
3:35 PM - 4:00 PM
 
4:00 PM - 4:50 PM
Session 3: Next Steps
4:00 PM - 4:50 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

4:50 PM - 5:00 PM
Closing Remarks
4:50 PM - 5:00 PM

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
Networking Reception Co-Hosted by GMTA and DITTA
5:30 PM - 7:00 PM

   

Date: 16 September 2024

Time: 1730 to 1900

Location: Rooftop Bell Harbor Convention Center

2211 Alaskan Way, Pier 66
Seattle, WA 98121

The reception will take place across the street from the meeting venue at: 2211 Alaskan Way, Pier 66.  Please bring your IMDRF meeting badge to gain entry to the building. The Secretariat and reception hosts will be available to onsite to assist with directions and escort you to the reception Please note, this event is not open to the press.

 

We look forward to welcoming you soon!

Time Zone: (UTC-08:00) Pacific Time (US & Canada) [Change Time Zone]

***PLEASE NOTE: ALL TIMES ARE PACIFIC TIMES**

DAY 2 AGENDA - TUESDAY, SEPTEMBER 17, 2024

Tuesday, September 17, 2024
8:30 AM - 9:00 AM
8:30 AM - 9:00 AM

Registration

8:30 to 9:00 AM

9:00 AM - 9:05 AM
9:00 AM - 9:05 AM

Welcome

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

9:00 to 9:05 AM

9:05 AM - 10:20 AM
9:05 AM - 10:20 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

10:20 AM - 10:45 AM
10:20 AM - 10:45 AM
 
10:45 AM - 12:10 PM
10:45 AM - 12:10 PM

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

12:15 PM - 1:00 PM
12:15 PM - 1:00 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

1:00 PM - 2:00 PM
1:00 PM - 2:00 PM
 
2:00 PM - 2:45 PM
2:00 PM - 2:45 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

2:55 PM - 3:35 PM
2:55 PM - 3:35 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

3:35 PM - 4:00 PM
3:35 PM - 4:00 PM
 
4:00 PM - 4:40 PM
4:00 PM - 4:40 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

4:40 PM - 4:45 PM
4:40 PM - 4:45 PM

Closing Remarks

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

4:40 to 4:45 PM

Time Zone: (UTC-08:00) Pacific Time (US & Canada) [Change Time Zone]