How the IVDR is Impacting Companion Diagnostics in the EU

Event Agenda

DATE: Wednesday, 19 October 2022

TIME:    6:00 – 6:05 PM   Welcome and Announcements

               6:05 – 7:05 PM   Program Presentation

               7:05 – 7:30 PM   Q & A

LOCATION:  This is an ONLINE event on zoom virtual platform       

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Program Details

The In Vitro Diagnostics Regulation 2017/746 (IVDR) came into force on May 26, 2022, creating the first European regulatory recognition of companion diagnostics (CDx).  While the IVDR sets out the expectations for companion diagnostics with an associated medicine, there is still a level of uncertainty on how the regulation will be implemented and practically executed.  This program will discuss the how the IVDR is impacting Companion Diagnostics in the EU, including a focus on challenges with clinical trial initiation in Europe for therapies that require the use of an in vitro diagnostic (IVD) in a trial.

Speaker Biography

Karin Hughes, Ph.D., is Senior Vice President Regulatory & Quality for Beaufort.  Karin has over 20 years’ experience in the in vitro diagnostics and life science industries.  She provides Beaufort’s clients with strategic planning and implementation of global regulatory and quality management programs, spanning early development through product clearance and continued on-market expansion.  Previously, Karin was VP Clinical & Regulatory Strategy for Astute Medical, Inc.  Karin serves on the Board for Directors for the Association of Medical Diagnostics Manufacturers (AMDM); currently as Vice President.  Karin has a B.S. degree in Chemistry from Hartwick College and a Ph.D. in Chemistry from the University of Virginia.

Registration Information:

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Contact

[email protected]

Pricing – Online – Registration (September 23, 2022 – October 18, 2022)

Cancellation Policy

There will be no refunds for cancellations.