Commercialisation as a Route to Clinical Impact – Workshop 2: Regulatory Requirements for IVDs and Medical Devices
|Starts:||09:00 23 Sep 2019|
|Ends:||14:00 23 Sep 2019|
|What is it:||Workshop|
|Organiser:||Faculty of Biology, Medicine and Health|
|Who is it for:||Current University students|
The Manchester Molecular Pathology Innovation Centre (MMPathIC) - in collaboration with the Diagnostics and Technology Accelerator (DiTA) and NIHR Manchester Biomedical Research Centre (BRC) – is pleased to offer two half-day workshops that will allow participants to develop their awareness and understanding of commercialisation as a route to clinical impact.
Understanding the regulatory route to market is key for successful commercialisation. These workshops are designed to give participants an overview of diagnostic test development, from the feasibility and patenting stages (Workshop 1), to the regulatory considerations one needs to be aware of if aiming for eventual uptake in the clinic (Workshop 2).
Workshop Content - Regulatory Requirements for IVDs and Medical Devices
• An introduction to the regulatory requirements for EU medical devices and IVDs
• Preparing for the new In Vitro Diagnostic Regulation (IVDR)
• Data Integrity and Good Quality Systems Practices
• Ask the expert panel discussion
There are no prerequisites for attendance. These workshops have been designed to be accessible to anyone who has an interest in gaining a basic overview of the pathway from idea/need, to the implementation of diagnostics into the clinic.
We invite representation from industry, clinical specialities (including pathology and lab medicine), academics and researchers (biomedical and the engineering and physical sciences), business development professionals and other stakeholders with an interest in diagnostic development.
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