OCT 28, 2020 6:00 AM PDT

Understanding the IN VITRO DIAGNOSTIC REGULATION (IVDR) Everything You Need to Know

Speaker
  • Independent Consultant, Chairwoman of the MedTech Europe Globalization Working Party, IVD Advisor to AHWP TC
    Biography

      Petra graduated from the University of Goettingen/ Germany with Diploma in 1980 and with Ph.D. in 1983. She joined Abbott Laboratories in the same year where she assumed increasing leadership responsibilities in the Regulatory Affairs Diagnostic arena. Petra is retired from Abbott since April 2019 and is working as an Independent Consultant. Petra has more than 35 years of experience in Regulatory Affairs and Quality Systems for Medical Devices, responsible for all international regulatory matters, medical event reporting, risk management, managing translation for more than 25 languages and labeling activities at Abbott Diagnostics Division. She has experience in building Quality Management System (QMS) according ISO 9001 and 13485. Since then she has used that knowledge in training, setting up a QMS or consulting in that field internally and externally. Other Activities include: Advisor to AHWP Technical Committee , Chairwoman of the EDMA Globalization Working Party dealing with new and revised worldwide regulations , Trainer activities for EU Commission, AHWP, ASEAN, APEC, USAID, WHO and National Health Authorities.


    Abstract

    DATE: October 28, 2020

    TIME:  6:00am PDT

     

    The new In Vitro Diagnostic Regulation (IVDR) has been defined as one of the most significant changes in the EU legislation for In Vitro Diagnostics in the past 20 years.


    Due to the nature of the changes, this cannot be considered just a change in the regulatory system. It affects the majority of the IVD product manufacturing functions as well as the diagnostic laboratories using them. These changes will provide a new classification system, improve traceability, introduce comprehensive post-market surveillance and elevate the scrutiny of documentation.


    Diagnostic laboratories need to carefully review their quality system, internal processes and portfolio of products in order to be IVDR-ready by the time the new regulation is implemented.
    This webinar will be part of a series that Abbott will be providing, with the end goal of supporting molecular laboratories during this important transition.

     

    Learning Objectives:

    • Summarize the differences between the current IVD Directive and new IVD Regulation, including rationale, goals and key changes
    • Understand the impact of IVDR on diagnostic laboratory activities
    • Provide insights on expected changes and key questions to ask manufacturers of IVD products in order for them to be IVDR- ready by May 22, 2022.

     

    Webinars will be available for unlimited on-demand viewing after live event.

     

    LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.


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