Description: The IVD device and pharmaceutical industries are concerned that new IVDR requirements for companion diagnostic conformity assessment will slowpatient access to novel precision medicines in Europe. Successful notified Body review and medicinal product authority consultation is required beforeIVDR certification can be achieved. Industry bodies are concerned that a lack of IVDR guidance and perceived long Notified Body timelines aremaking Europe an uninviting market to launch new products. This perception is exacerbated by the lack of pharmaceutical industry experience with theEuropean model of Notified Body third party conformity assessment. This educational session will discuss the IVDR requirements for companion diagnostic conformity assessment and at what point in productdevelopment timelines they should be considered to improve the efficiency of Notified Body review and medicinal product authority consultation. The following issues will be discussed: - The impact of IVDR on medicinal clinical trials. - The latest Notified Body insight and experience of companion diagnostic conformity assessment. - Factors to consider for success. - Common pitfalls and how to avoid them. The presenters will also discuss frequently asked questions about Notified Body review from the pharmaceutical industry.
Learning Objectives:
Understand IVDR requirements and timelines for companion diagnostic conformity assessment.
Understand factors to consider when setting up clinical trials incorporating a CDx device.
Avoid common errors in CDx Notified Body technical review and EMA consultation.
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