The European Union IVD “revolution” has been in motion since 2012. Many of the larger companies are already putting the systems and requirements in place to prevent any interruption of business as we are now in final stages of finalizing through the EU Legislative process and expect the transition phase to begin as early as late 2016.
This Executive Brief will address the key items your leadership team needs to know to understand the business impact the new Regulations will have on the ability to sustain IVD sales in the European Union. Led by IVD expert and Head of UL Global Medical Device Services, Sue Spencer, who has over 30 years’ experience and key insights into both the IVD manufacturing and regulatory processes, she will
A first in the series covering the extensive changes to the EU IVD regulations, this 20-minute brief will help establish the enormity of the challenge of meeting the regulation and urgency to take action now with your executive team. Future webinars will take a deeper dive into the major areas of impact.
Date: Tuesday June 28th, 2016
Time: 11-11:30 EDT (GMT -4)
Where: Live online - Complimentary 20 minutes presentation and 10 minutes live Q&A
Registration Page: https://attendee.gotowebinar.com/register/2917811765149430530
Who Should Attend:
- IVD Industry – Including current unregulated reagents, clinical chemistry, Immunology, molecular diagnostics, microbiology
- C-Suite – COO, CMO, CFO
- Other Business Leaders
Presenter: Sue Spencer, Head of Global Medical Device Services at UL
Sue Spencer has over 30 years’ experience in the IVD industry where she has held positions in R&D, Manufacturing and Quality Assurance; she has worked in the Notified Body arena since the initial introduction of the IVD and Medical Devices Directives and is now involved with the development of the new regulation.
Sue has over 10 years’ experience working for several Notified Bodies; she currently chairs the European IVD Notified Body Working Group coordinating the notified body responses to the changing regulatory environment. Sue also participates in the Commission IVD Technical Work Group and chairs a sub group preparing guidance on the revised IVD classification.
In the past Sue has worked as a consultant establishing her own consultancy before joining Abbott Diagnostics Division where she was Manager for International Quality Systems and Risk Management for the Division for over 6 years.
Sue is an experienced tutor on a variety of topics including the IVD Directive, ISO 13485 and risk management.