7:30 AM - 9:00 AM | Registration 7:30 AM - 9:00 AM
Registration & Morning Networking
7:30-9:00 AM
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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
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Welcome address by US FDA
- Robert M. Califf, Commissioner, US FDA
9:05-9:15 AM
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Welcome address by Industry
- Janet Trunzo, Chair; Global Medical Technology Alliance (GMTA)
9:15-9:25 AM
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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
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Perspective from Industry
- Nicole Taylor Smith, Philips
9:40-9:55 AM
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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
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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
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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
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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
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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
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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
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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
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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
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Expanded level controls- postmarket
- Koko Nakamichi, NCAR Secretariat, Pharmaceuticals and Medical Devices Agency (PMDA)
2:30-2:40 PM
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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
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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
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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
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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
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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! |