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Tuesday, June 26 • 10:30am - 11:45am
#238: The European Medical Devices Regulation and MDUFA IV: One Year On - Is It Any Clearer?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-582-L04-P; CME 1.25; IACET 1.25; RN 1.25

2017 was a big year for devices in Europe and US. Last year an overview of the new regulations was presented but it was clear that many questions remained in both US and EU about how the new regulations would affect the way medical devices are manufactured, tested and sold. The transition period in EU is now one year further along…have we had the enabling acts promised? Do they make life easier? What is still missing? Has the confusion been allayed by meaningful guidance? Is your supply chain sufficiently controlled? Are your MAIDs in compliance? In US, how is MDUFA IV shaping the devices market in the US? Have the new FDA user fees for de novo medical device registrations impacted manufacturers’ plans for commercialization of cutting-edge products in the US? Is the reduced fee for small-businesses for de novo applications too high for some prospective US medical device market companies? This session will review what has been seen to date and will consider what may be yet to come as we negotiate the many pitfalls and hurdles facing device manufacture, registration and commercialization in the forthcoming years.

Learning Objectives

ACompare how your organization is managing the change to the new EU regulations; Recognize what changes the MDUFA IV regulations have already made and identify what areas may continue to change; ; Identify areas within your organization that need to change to comply with the new regulations; Interpret the new regulations and guidance to benefit individual working environments.

Chair

Angela Stokes, MS

Speaker

Industry Perspective
Theresa Jeary, MSc

Industry Perspective
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 Theresa Jeary

Theresa Jeary

Head of Notified Body, Lloyds Register Quality Assurance (LRQA)
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 departments... Read More →
avatar for Angela Stokes

Angela Stokes

Senior Director, Global Regulatory Consulting, Syneos Health
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 development... 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 →

Tuesday June 26, 2018 10:30am - 11:45am EDT
Room 204AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session