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