Patient Engagement for Medicines Development in a nutshell

The Patient Engagement Quality Guidance

A practical guide to planning, developing and assessing the quality of patient engagement activities and projects throughout the development and lifecycle of medicines.


The tool was co-developed with a large community of stakeholders (more than 100 people from 51 organisations), representing patient associations, industry, academics, researchers and external experts.


Who can use the tool? Simple. All stakeholders working on patient engagement projects (for example, patient advocates, clinical investigators, researchers, or sponsors).

Suitable for all projects

You can use it for a PE project that takes place at any point along the research and medicines-development continuum, lifecycle of medicines, or care continuum and can be applied to health and social research.

Seven Patient Engagement Quality Criteria

The guidance introduces seven quality criteria to assess patient engagement practices.These have been consolidated from published PE frameworks and co-developed further by PFMD Contributors.

There are two versions or scenarios of the PE Quality Guidance Tool – scenario 1 will help you in planning a patient engagement project, and scenario 2 will help you assess your ongoing or completed project.

Download the PE Quality Guide

Next steps

We are actively working towards transforming this tool in a interactive and dynamic format, fully integrating it in Synapse.