Aimed at professionals new to IVD regulations or needing an update on recent regulatory changes, this course will provide a thorough understanding of the regulatory requirements for in vitro diagnostics (IVDs) in the European Union.
Published in 2017, the EU IVD Regulation brings radical changes which must be known and understood by the IVD industry in order to ensure the business continuity of each IVD manufacturer. This 2-day course will focus on the new EU IVD-Regulation and will provide the attendees with a detailed comprehension of its most challenging aspects together with practical suggestions on how to start preparing for it.
Delegates will be able to cement this knowledge through case studies and practical exercises, with additional time on the course provided to discuss the implications of Brexit.
This training will be delivered by one of our two expert trainers below:
Dr Maurizio Suppo has been a Principal Consultant at Qarad since 2012. He was previously the Director of the EDMA. His main responsibilities lay in the regulatory and standardization fields, with primary involvement in the drafting and approval process of the European IVD Directive 98/79/EC.
Dr Dirk Stynen has many years of industry experience, including 7 years spent as a Department Head at Innogenetics, covering Quality Assurance, Quality Control, Regulatory Affairs and Labelling. He has since set up Qarad, assisting IVD and MD companies worldwide in achieving compliance with European Regulations and Quality System requirements.
This two-day course is aimed at the following professionals:
I've chosen this course in order to have a clear overview of the new EU IVD-Regulations. I really enjoyed the clean description of the new requirements through real and actual examples, specifically regarding the performance evaluation of IVDs.
I really enjoyed the insight into legislation from the industry perspective.