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2019 Global Regulatory and Quality Update
June 18, 2019 7:30 AM - 3:00 PM
(EDT)
Description
Collaboratively hosted by the ASQ Biomedical Division/New England Discussion Group, MassMEDIC and the RAPS Boston chapter, this annual full-day program is designed to give regulatory, quality and compliance professionals a detailed update on essential regulatory news from around the globe.
Featured presentations will include:
An update on Brexit from RAPS Executive Director, Paul Brooks International Medical Device Regulators Forum (IMDRF):
Advancing the Use of Standards for Global Harmonization, by Dr. Gail Rodriguez, senior policy advisor, US FDA
An update on MDSAP from Brain Ludovico, executive director, MDSAP Regulatory Certification, NSF Health Sciences
The status of the EU MDR and an IVDR update by Glen Emelock, US medical operations manager, National Standards Authority of Ireland