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Session 5: Planning for the IVDR in Europe
Session Chair(s)
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)
Speaker
Claudia Dollins, PhD, RAC
GlaxoSmithKline, United States
Vice President, Precision Medicines, Global Regulatory Affairs
Speaker
Seamus Kearney, MS, MSc
ARC360, United Kingdom
CEO
Speaker
Jude O'Donnell, PhD, MSc
Almac, United Kingdom
Head of Regulatory Strategy
Speaker
Sue Spencer
Qserve Consultancy B.V. , Netherlands
Head of In Vitro Diagnostics & Principal Consultant
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