MassBio Headquarters
300 Technology Square, Cambridge, Mass.
Friday, June 7, 2019
12:00 – 1:30 p.m. EDT

EU Regulatory Update – EU Medical Device Regulation Overview, GMP Changes and the Impact of Brexit

The first portion of this session will cover the regulatory background in Europe and discuss the roles associated with the EU MDR, the manufacturing requirements of the EU MDR and how to comply with premarket and postmarket requirements for conformity assessments. The second portion of the program will provide an update on EU Clinical Trial Regulations, EU GMPs changes and the impact of Brexit from a regulatory and GMP point of view. There will be time reserved for Q&A and discussion.

About the Presenters

Kimberly Trautman, Executive Vice President, Medical Device International Services

Kim Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. Her experience includes leading international initiatives for the U.S. FDA to include the conception and development of the International Medical Device Single Audit Program. She was also responsible for writing the current U.S. FDA Medical Device Quality System (QS) regulation, 21 CFR 820, and leading the implementation, rollout and training associated with the QS regulation. She also led continuing harmonization efforts for ISO 13485 since its inception in 1994, where she is an international delegate to ISO/TC 210, author of ISO 13485, and the U.S. Technical Advisory Group co-chair for ISO/TC 210.

Jim Morris, Executive Director, Pharma Biotech

Jim Morris has over 25 years of pharmaceutical management experience in both plant operations and corporate offices, working with Pfizer, Cilag AG and Mass Biologics in the U.S. and Europe. He has held positions as Deputy Director QA/QC and Regulatory Affairs while at Mass Biologics, Director of QA/QC for the Biologics business unit of Cilag AG and a number of quality assurance and manufacturing roles with Pfizer over a 16-year timeframe, culminating as the head of Quality Assurance for Pfizer in Latina, Italy.

Andrew Papas Vice President, Pharma Biotech Regulatory Affairs

Dr. Andrew Papas provides leadership and guidance on global regulatory affairs, quality and drug development programs. His unique combination of expertise in global regulatory affairs, industry leadership, management and laboratory science allows him to provide clients with strategic and technical assistance in the development of innovative global regulatory solutions and practical business-minded solutions for pharmaceutical and biologics firms.

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