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Virtual

Dec 08, 2021 9:50 AM - Dec 09, 2021 4:30 PM

(US Eastern Standard Time)

Diagnostics and Personalized Medicine Conference

This event is now offered in a new entirely virtual format.

Session 5: Planning for the IVDR in Europe

Session Chair(s)

Maria C. M, Orr, PhD

Maria C. M, Orr, PhD

Head of Precision Medicine, Biopharmaceuticals

AstraZeneca, United Kingdom

The regulatory framework for in vitro diagnostics (IVD) in Europe is changing following the introduction of the new In Vitro Diagnostic Regulation (IVDR), which entered into force with its publication on 26th May 2017. Following a 5-year transition period the IVDR will come into application on 26th May 2022, replacing the existing IVD Directive (98/79/EC; IVDD). The introduction of this new regulation has major impacts for precision medicine with the introduction, for the first time, of specific regulations for companion diagnostics in Europe. (CDx) devices will be regulated by designated notified bodies with clear requirements on vital aspects of device performance and oversight to ensure that the quality, safety, and performance of these devices is appropriate for their intended purpose. IVDR also, for the first time, regulates in-house tests offered by Single Healthcare Institutions (SHI) which will also have implications for the provision of testing for precision medicines. In this session we will:

  • Describe the changes being introduced by IVDR
  • Explain the implications of these changes and their impact on precision medicine
  • Discuss and debate the opportunities and challenges posed by IVDR on the provision of current and future precision medicine

Learning Objective :
  • Explain the IVDR and its impact on the regulation of companion diagnostics
  • Evaluate the impact of IVDR for their projects
  • Create a plan for current and future submissions of companion diagnostics in Europe to ensure success

Speaker(s)

Claudia  Dollins, PhD, RAC

Speaker

Claudia Dollins, PhD, RAC

GlaxoSmithKline, United States

Vice President, Precision Medicines, Global Regulatory Affairs

Seamus  Kearney, MS, MSc

Speaker

Seamus Kearney, MS, MSc

ARC360, United Kingdom

CEO

Jude  O'Donnell, PhD, MSc

Speaker

Jude O'Donnell, PhD, MSc

Almac, United Kingdom

Head of Regulatory Strategy

Sue  Spencer

Speaker

Sue Spencer

Qserve Consultancy B.V. , Netherlands

Head of In Vitro Diagnostics & Principal Consultant

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