Corporate report

How to complete an EOI for the MHRA-NICE Real-World Evidence Scientific Dialogue

Updated 5 November 2026

You should read this guidance alongside the:

• MHRA-NICE Real-World Evidence Scientific Dialogue guidance
• expression of interest (EOI) form

It provides practical guidance on the information requested in each part of the form and the level of detail expected. It is intended to help applicants:

• assess whether their proposal is suitable for a pre-competitive workshop
• describe a clear and practical real-world use case
• define the principal real-world evidence (RWE) question or uncertainty for discussion
• propose realistic workshop objectives
• explain the wider relevance and potential impact of the proposed workshop

Applicants should check the current application dates and programme information before completing the form.

Before completing the EOI form 

Applicants should confirm that their proposal aligns with the aims and priority criteria, and meets the eligibility requirements, for the MHRA-NICE RWE Scientific Dialogue.

A suitable proposal should normally:

• address a defined RWE question or uncertainty
• be relevant beyond a single product, organisation or development programme
• provide a practical use case or scenario around which a workshop discussion can be structured
• benefit from discussion involving multiple stakeholders
• allow meaningful discussion at a non-confidential or general methodological level; and
• have the potential to support shared learning, methodological development or future guidance

The MHRA-NICE RWE Scientific Dialogue is not intended to provide product-specific regulatory, health technology assessment or conformity-assessment advice. Applicants seeking advice on a particular product, study or development programme should consider the relevant MHRA or NICE advice service.

Helpful links:

• medicines: get scientific advice from the MHRA
• strategic advice form NICE

Application details

Submission cycles

Up to four workshops will be held each year across two submission cycles, with up to two workshops per cycle: 

• the application window runs from November to February, with workshops held the following May.
• the application window runs from May to August, with workshops held in November.

The application dates will be published here.

Workshop format

Selected applicants will participate in a half-day, pre-competitive workshop jointly convened by the MHRA and NICE, with approved body representation where relevant. 

Planning and preparation

Selected applicants will work collaboratively with the MHRA, NICE and other relevant participants to refine the workshop scope, identify the expertise required and develop the agenda and supporting materials.

Additional participants

Other organisations or experts may be invited where their participation would add value to the discussion and shared learning.

Follow-up

An optional virtual follow-up meeting will be offered.

Public outputs

Participants will agree what non-confidential information can be shared publicly. Outputs will include a brief discussion summary and may include further collaborative outputs, such as a peer-reviewed publication.

No fee

The MHRA will not charge a fee for participation.

Completing the EOI form

You must complete the EOI form.

The form has three sections, with guidance for each provided below.  You can download a copy of your responses after submission. 

Section 1: about you

Question 1.1: name of organisation 

If the application involves more than one organisation, nominate one organisation as the lead applicant. The lead applicant should complete the form and act as the main contact for correspondence.

Question 1.2: organisation Type

Select the category that best describes the lead applicant organisation. If several organisations are applying jointly, select “Collaborative or consortium-based partnership”. If none of the categories is suitable, select “Other” and provide a brief description.

Applicant category	Description (who should select this)	Typical characteristics / examples
Commercial industry sponsor	Organisations developing or marketing regulated health products	Pharmaceutical companies, biotech firms, medical device manufacturers, digital health companies
Academic or research institution	Organisations primarily undertaking academic, clinical, or methodological research	Universities, academic research groups, registryhosting institutions
Charity or patientled organisation	Notforprofit organisations representing patients or funding diseasefocused research	Medical research charities, disease foundations, patient advocacy organisations
Public sector or governmentaffiliated body	Organisations operating within or on behalf of public health or government systems	NHS organisations, NIHR infrastructure, public data custodians, government agencies
Technology or data service provider	Organisations providing data, platforms, analytics, or methodologies rather than regulated products	RWE service providers, registry operators, AI / analytics companies
Collaborative or consortiumbased partnership	Joint applications involving multiple organisations or sectors	Public–private partnerships, academic–industry consortia, multisponsor collaborations

Question 1.2.1: if commercial industry sponsor, please specify

For commercial industry sponsor organisations with more than 250 employees, please select “Large Enterprise”. For organisations with equal to or less than 250 employees, please select “Small or Medium-sized Enterprise”. 

Section 2: workshop questions

Question 2.1: what is the title for your proposed workshop? 

Provide a concise title that clearly describes the main topic of the proposed workshop. 

Responses should be no more than 15 words.

Question 2.2: what therapeutic area(s) does this proposal relate to?  

List the relevant disease(s)/condition(s) and/or therapeutic area(s) (e.g. oncology, cardiovascular disease, mental health, rare diseases). If the proposal is methodological or cross-cutting and is not linked to a particular disease area, state “Not disease-specific”.

Question 2.3: does your proposed discussion relate primarily to

Select whether the proposal primarily concerns: 

• medicinal products
• medical devices, including in vitro diagnostic (IVD) devices, digital tools, and software or AI as a medical device (SaMD / AIaMD)
• both medicines products and medical devices

This information will help identify the organisations and areas of expertise that may need to be represented in the workshop.

Question 2.3.1: please describe the medicinal product and/or medical-device context relevant to your proposal

Briefly describe the relevant type of medicinal product, intervention, device or technology and, where applicable, its intended purpose and expected clinical or healthcare benefit. Explain the wider evidence-generation or decision-making context in which the proposed issue arises. 

The proposal does not need to relate to a named product. If it is cross-cutting, describe the types of products, technologies or decisions to which the issue is relevant.

Responses should be no more than 100 words.

Question 2.4: what specific scenario or example would you like the workshop to work through?

Describe a specific real-world scenario or example that illustrates the issue you would like to discuss and provides a practical basis for workshop discussion. The scenario does not need to involve a named product or device, but should clearly identify the relevant product or device type or group and, where applicable, its intended purpose.

Include only the details needed to understand the scenario, such as the population, setting, data source, expected benefit, relevant outcomes or device-specific performance or safety parameters, and key limitations or uncertainties. 

Avoid describing only a broad topic or general area of interest.

Responses should be no more than 150 words.

Question 2.5: what specific real-world evidence question or uncertainty would you like the workshop to address? 

Clearly describe the principal RWE question or uncertainty that you would like the workshop to explore, and explain why an RWE approach is relevant to the use case or scenario  described in question 2.4. 

Relate the question to the relevant product, intervention, device or technology type or group and, where applicable, its intended purpose. Specify the aspect requiring discussion, such as the data source, methodology, study design, endpoint, decision context or a device-specific performance or safety parameter.

Focus on a defined question or uncertainty rather than a broad topic or general request for guidance.

Responses should be no more than 150 words.

Question 2.6: what are the 3-5 key objectives and/or discussion questions for the proposed workshop? 

List 3 to 5 clear and specific objectives describing what the workshop should achieve through discussion of the principal RWE question or uncertainty identified in Question 2.5. The objectives should be realistic for a single half-day workshop.

Objectives could include:

• clarifying relevant regulatory, health technology assessment (HTA) or conformity-assessment considerations
• exploring methodological options and their limitations
• identifying key evidence gaps or uncertainties
• considering the suitability of relevant data sources, outcomes, or performance or safety parameters; or
• identifying areas of agreement, further work or potential future guidance

Avoid broad objectives that do not specify the intended focus or outcome of the discussion.

Responses should be no more than 150 words.

Section 3: suitability, value, and governance

Question 3.1: why is this topic suitable for discussion in a pre-competitive, multi-stakeholder workshop setting?

Explain why the topic is suitable for discussion in a multistakeholder, precompetitive workshop. Describe the common challenge or uncertainty it raises, the stakeholders who would benefit from the discussion, and its potential to support shared learning beyond a single organisation, product or development programme.

Explain how collective discussion could build shared understanding, explore areas of uncertainty or differing perspectives, and generate learning that could be shared more widely.  

The MHRA-NICE RWE Scientific Dialogue is not a route for obtaining regulatory, health technology assessment or conformity-assessment advice on an individual product, study or development programme.

Responses should be no more than 150 words.

Question 3.2: what is the anticipated impact of the proposed workshop?

Describe the potential impact of the proposed workshop on the generation or use of RWE for medicinal products and/or medical devices. Explain how the discussion and resulting shared learning could inform evidence generation, methodological approaches, regulatory, HTA or conformity-assessment decision-making, or future guidance.

Where relevant, explain how the workshop would complement or add value to existing work, guidance, collaborations or stakeholder engagement rather than duplicate them.

Responses should be no more than 150 words.

Question 3.3: are there any confidentiality, intellectual-property, commercial-sensitivity or data-access constraints that could limit open discussion or shared learning in a multi-stakeholder workshop?

Indicate whether there are any confidentiality, intellectual-property, commercial-sensitivity or data-access constraints that could limit open discussion.

If there are no material constraints, confirm that the issue can be discussed at a general or methodological level.

Question 3.3.1: please briefly describe these and how they could be managed

If constraints apply, briefly describe them and explain how they could be managed while allowing meaningful precompetitive discussion and the development of non-confidential outputs.

Question 3.4: are there any other relevant considerations?

Provide any additional information relevant to planning the workshop, such as:

• important timelines or dependencies;
• ethical or data-governance considerations;
• patient or public involvement;
• known practical limitations; or
• links with related work or initiatives.

You may also identify particular areas of expertise that would support the discussion and inform the selection of participants, for example clinical, methodological, regulatory, HTA, data or technology expertise, including expertise in AI or software as a medical device.

If there are no additional considerations, state “none”.

What happens after submission

The MHRA will acknowledge receipt of the EOI and confirm whether it is eligible for assessment. The MHRA aims to confirm eligibility within two weeks of receipt. Applicants may be contacted if clarification or further information is required.

Applicants can normally expect to be notified of the selection outcome within six weeks of the application window closing.

Selected applicants will be invited to an initial virtual planning meeting, which will usually take place within two weeks of the applicant confirming their participation, to:

• refine the workshop scope and objectives
• identify the expertise and participants required
• agree the agenda, briefing materials and presentations

Applicants should be prepared to contribute actively to planning and preparation. Workshop materials will be developed collaboratively by the applicant, the MHRA, NICE, approved bodies where relevant, and other invited participants.

Participants will also agree in advance what non-confidential information may be included in publicly shareable workshop outputs.

These timescales are indicative and may vary depending on application volume, the need for further information and participant availability, etc. 

Contact us

For questions about completing the EOI form or assistance with a submission to the MHRA-NICE RWE Scientific Dialogue, contact: rwe@mhra.gov.uk.