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Commercialisation as a Route to Clinical Impact – Workshop 2: Regulatory Requirements for IVDs and Medical Devices

Dates:23 September 2019
Times:09:00 - 14:00
What is it:Workshop
Organiser:Faculty of Biology, Medicine and Health
Who is it for:Current University students
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  • By Faculty of Biology, Medicine and Health

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.

Workshop Information

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

Prerequisites/ Audience

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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