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Wednesday, June 26 • 8:00am - 9:15am
#314: Medical Devices: EU Medical Device Regulation, PMDA Updates, and US MDUFA IV – Where Are We Now?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-655-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.

Chair

Angela Stokes, MSc

Speaker

The Medical Device Regulation: Less Than a Year to Go! Where Are We Now?
Angela Stokes, MSc

Recent Progress of Balancing Between Risk/Benefit Assessment and Patient Access to Medical Devices in Japan
Nobuhiro Handa, DrMed, MD

MDUFA IV: Another Year has Passed! What are the Highlights?
LeeAnn L Chambers, MS



Speakers
LC

LeeAnn Chambers

Principal Research Scientist, Global Regulatory Affairs, CMC - Devices, Eli Lilly and Company
LeeAnn Chambers has been a Regulatory Affairs professional at Eli Lilly and Company for 22 years. She assists teams in developing global registration strategies for medical devices and drug / device combination products. She has guided the preparation of device content in US IND... Read More →
avatar for Nobuhiro Handa

Nobuhiro Handa

Principal Reviewer, Office of Medical Device, Pharmaceuticals and Medical Devices Agency (PMDA)
I graduated the University of Tokyo, Faculty of Medicine in 1985. Since then I had been a cardiovascular surgeon over 28 years. I was trained in the US for 4 years at Mayo clinic as well as Massachusetts General Hospital. I changed my career at age of 52 from clinical physician to... Read More →
avatar for Angela Stokes

Angela Stokes

Vice President, Head Global Regulatory Consulting, Syneos Health
Angela has almost 30 years of experience in medicinal product and medical device development. Her strengths include regulatory and strategic advice, authorship of regulatory submissions, regulatory writing, regulatory research, and compliance with relevant guidelines and standards... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA