Expression of interest - IVD roadmap event

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The MHRA is producing an IVD Roadmap that has 5 basic themes that run across the Agency from science research and innovation through to safety and surveillance. BIVDA and the MHRA are holding a joint workshop to socialise aspects of the roadmap, map out the different kinds of support available to developers and understand the pre-market support that industry would like to see from the MHRA.

The MHRA is keen to explore with industry and the IVD UK network, including DHSC, NICE, NHS England, UKRI, the NIHR MICs and the Devolved Administrations where it should position itself in the IVD landscape.

The event is targeted at SMEs as well as multi-nationals, and organisations involved in the development, evaluation and delivery of IVDs. The aim is to further encourage a co-ordinated approach to pre-market support and understand the needs of different stakeholders from a regulatory perspective.

Putting patient safety and well-being first, the MHRA is wanting to take a proactive approach to supporting innovators and continue to build its reputation as a responsive sovereign regulator.

Stakeholders involved will be expected to provide insight based on their experiences; the intention is for this workshop to be engaging and full of discussion.

If your organisation would be interested in attending, please complete the below form by Friday 13 January. Please only submit one form per organisation. Where an organisation submits multiple forms, only the first submitted will be taken into account.

Please note this form is to express interest only. Submission of this form does not guarantee an invitation to the event.

If you have any questions, please contact Ashleigh Batchen (ashleigh@bivda.org.uk).

What products or products types does your organisation have involvement with? Example: SaIVD; haematology; genetic tests; companion diagnostics; Covid-19 lateral flow. *

What do you hope to gain from attending this event? *

What economic operator category would your organisation fall under? Please select all that apply. *

Manufacturer

Distributor

Importer

UK Responsible Person

Other:

Required

Which size best reflects your organisation? *

Microenterprise (1-9 employees)

Small enterprise (10-49 employees)

Medium enterprise (50-249 employees)

Large enterprise (250+ employees)

Other:

Please nominate a single named individual who would represent your organisation and receive all correspondence for this event. *

Which company will this individual be representing? *

Please provide the email address of the nominated person above. *

Please confirm that this nominated person is available to attend an in-person event in London, Friday 10 February, 10:00-16:30. *

Available

Unavailable

What is the experience of this nominated person, and why should they attend the event? There will be limited places per economic operator category - please answer in relation to the economic operator categories you would be representing rather than your company overall. *

Does this nominated person consent to BIVDA sharing this information, including contact details, with MHRA for the purposes of managing the attendee list and providing formal invitations (if selected)? *

I consent to BIVDA sharing the information within this form with MHRA

I do not consent to BIVDA sharing the information within this form with MHRA

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