返回 Agenda
What’s New in Devices: European Medical Device Regulations and MDUFA IV
Session Chair(s)
Angela Stokes, MSC
Vice President, Head Global Regulatory Consulting
Syneos Health, United Kingdom
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 Objective : Summarize recent global device regulatory changes; Describe potential approaches for development and lifecycle management strategies to ensure future compliance.
Speaker(s)
Are You Ready for the Medical Devices Regulation? What Should Manufacturers be Considering Now
Angela Stokes, MSC
Syneos Health, United Kingdom
Vice President, Head Global Regulatory Consulting
The EU Medical Device Regulations: The Notified Body View
Theresa Jeary, MSC
Lloyds Register Quality Assurance (LRQA), United Kingdom
Head of Notified Body
US Perspective
LeeAnn L Chambers, MS
Eli Lilly and Company, United States
Principal Research Scientist, Global Regulatory Affairs, CMC - Devices