Date :
Place : United States, Chicago
Contact Person:John Robinson
Description:
This Seminar will look at what to expect when the new regulation is implemented. Including: the transition period, Effect on Notified Bodies, Impact of the MDR on Quality Management Systems (QMS), technical documentation, clinical trial requirements, UDI and combination products.Deadline for abstracts/proposals : 25th June 2018
Organized By :NetZealous LLC DBA GlobalCompliancePanel
Keynote Speakers : Salma Michor PhD, MSc, MBA, CMgr, RAC Salma Michor is founder and CEO of Michor Consulting Schweiz GmbH, serving such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH. She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission. She holds a PhD in thermal process engineering and an MSc i
Conference Highlights :Course "The New EU Medical Device regulation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Regulation proposals of the European Commission Background In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medi
Venue :Chicago, IL, USA
Check the event website for more details.