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Medical Devices: EU Medical Device Regulation, PMDA Updates, and US MDUFA IV – Where Are We Now?
Session Chair(s)
Angela Stokes, MSC
Vice President, Head Global Regulatory Consulting
Syneos Health, United Kingdom
Since 2017 we have analyzed the new EU Medical Devices Regulations, the enabling acts (still to come!) and MDUFA IV. Now one more year on, we examine what has improved, where action is still required and what to do now to keep products on the market and review new initiatives in Japan.
Learning Objective : Describe how your own organization is managing the change to the new EU regulations; Assess what changes the MDUFA IV regulations have already made and how things might change further; Discuss the changes happening in Japan; Identify areas where your organization still needs to move forward to comply with the new regulations; Interpret the new regulations and guidance to benefit their own working environment.
Speaker(s)
The Medical Device Regulation: Less Than a Year to Go! Where Are We Now?
Angela Stokes, MSC
Syneos Health, United Kingdom
Vice President, Head Global Regulatory Consulting
Recent Progress of Balancing Between Risk/Benefit Assessment and Patient Access to Medical Devices in Japan
Nobuhiro Handa, DrMed, MD, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Principal Reviewer, Office of Medical Device I
MDUFA IV: Another Year has Passed! What are the Highlights?
LeeAnn L Chambers, MS
Eli Lilly and Company, United States
Principal Research Scientist, Global Regulatory Affairs, CMC - Devices