EU MDR Labeling Compliance: Learn the Lessons from UDI
Date: 05 December 2017; 3PM GMT / 4PM CET
As part of the MedTech Summit Digital Week we are sponsoring and presenting a webinar on EU MDR, featuring two industry experts, Mark Cusworth and Andrew Love.
EU MDR is being viewed as an extension of the FDA’s UDI (Unique Device Identification), but also a ‘step up’. However, it’s more detailed and more complex due to the local language requirements needed for Europe.
The introduction of UDI requirements into the EU is good news for organizations that are already along the pathway of adopting systems and processes to support FDA UDI compliance. However, for those that aren’t – and indeed those that may have made only basic adjustments to their labeling infrastructure in response to the regulations – there are five key learnings that have emerged from the UDI experience that may help inform best practice adoption with EU MDR.
Join us for this 60-minute information packed webinar to discover why EU MDR will change the medical device labeling landscape globally and how to best meet the impending challenges.
MEET OUR SPEAKERS
Andrew Love, Be4ward
Andrew Love is a multi-award-winning packaging and artwork management strategist, leader and author.
Andrew spent 10 years as head of global packaging design operations at GlaxoSmithKline, the world’s second largest pharmaceutical company at the time. During his time there he oversaw the transformation of the global artwork management activities into a world-class, award-winning capability.Andrew is one of the founders of Be4ward which helps pharmaceutical, biotech and other healthcare companies and their supply base to improve patient safety and drive additional value from their product range. He now develops products for, and works with, a number of pharmaceutical and healthcare companies in achieving these aims.Andrew, a professional engineer and MBA with over 20 years of experience, has worked with many of the world’s largest life-sciences companies.
Mark Cusworth, PRISYM ID
Mark Cusworth is the VP Research and Development at PRISYM ID. He has over 15 years of experience heading up a team providing off the shelf and tailored solutions to Life Science companies. During this time, he has seen many changes to the industry including significant tightening of regulations and challenges of globalization. His primary objectives are to target the ongoing investment in research, development and quality effectively and to lead the company in-house research and development in order to maintain the market leading position of PRISYM ID’s world class label management software.