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Tuesday, June 20 • 2:00pm - 3:15pm
#252: What’s New in Devices: European Medical Device Regulations and MDUFA IV

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

With the new medical device and IVD regulations in the EU, plus the renewal of MDUFA in the USA, the year 2017 is a pivotal and disruptive period for medical device and diagnostic regulations. This session explores notable developments in global device regulation

Learning Objectives

Summarize recent global device regulatory changes; Describe potential approaches for development and lifecycle management strategies to ensure future compliance.

Chair

Angela Stokes, MS

Speaker

Are You Ready for the Medical Devices Regulation? What Should Manufacturers be Considering Now
Angela Stokes, MS

The EU Medical Device Regulations: The Notified Body View
Theresa Jeary

US Perspective
LeeAnn L Chambers, MS



Moderators
avatar for Angela Stokes

Angela Stokes

Senior Director, Global Regulatory Consulting, INC Research
Angela Stokes has over 27 years experience in the pharmaceutical and medical device industry in a variety of Regulatory Affairs based roles, most recently as Senior Director Global Regulatory Consulting at INC Research. She is experienced in medicinal product and medical device d... Read More →

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 20 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 Theresa Jeary

Theresa Jeary

Technical Manager, Lloyds Register Quality Assurance
Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory department... Read More →
avatar for Angela Stokes

Angela Stokes

Senior Director, Global Regulatory Consulting, INC Research
Angela Stokes has over 27 years experience in the pharmaceutical and medical device industry in a variety of Regulatory Affairs based roles, most recently as Senior Director Global Regulatory Consulting at INC Research. She is experienced in medicinal product and medical device d... Read More →


Tuesday June 20, 2017 2:00pm - 3:15pm
S404a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616