1. EUPATI guidance document for patient involvement in industry-led medicines R&D Kay Warner on behalf of the EUPATI team

2. Contents
Why have guidance?
Process followed (review, workshops, consultation)
Content of industry guidance
Key points within each chapter (referencing online guidance document)
Questions encouraged

3. EUPATI guidance documents for patient involvement and interaction – Why?
Patients & patient organisations to be involved more widely
include early & post-approval stages, not confined to clinical development
Overarching guidance on meaningful and ethical interaction is missing in many areas, especially in R&D, causing insecurity
Existing codes/regulations hold mostly legal & ethical content, i.e. collaboration, communication, funding -- do not cover patient involvement in R&D
e.g. EFPIA, EATG code, PCWP framework, ECAB, EMA framework, HTAi
Language needs to be more directive towards patient involvement
Clear default statement that collaboration is allowed unless expressly forbidden

4. EUPATI Guidance documents to support the systematic interaction in R&D
After extensive consultation, EUPATI has developed guidances for the interaction of patient organisations with stakeholders
in industry-led R&D
in HTA
in regulatory processes
in ethics committees
Intensive public consultation ended in Sept 2016,
publication in December 2016
Source: EUPATI Guidance documents on patient involvement in R&D (with regulatory processes, industry-led R&D, Ethics Committees and HTA bodies),  EUPATI.eu  Resources  Guidances

5. EUPATI Guidance on interaction in industry-led R&D
Identify specific instances of interactions to explore synergies in how to create roles for patients in R&D in a systematic way
Guidance on
Defining the “patient” (patients, carers/family, representative, expert patient, advocate, EUPATI Fellow)
Operating Procedures (long-term interaction, operational principles)
Defining the Interaction (objective of projects, tools and methods, patient population, use of outputs, information flow, contractual terms)
Ways for identification of patients for the interaction
Key elements of a written collaboration agreement
Rules of Compensation
Events and Hospitality (codes, convenience, accessibility)
Transparency and disclosure
Appendices (Roadmap on PPI in R&D, Codes of Practice)