The European Patients’ Academy (EUPATI) is a pan-European Innovative Medicines Initiative (http://www.imi.europa.eu/) project of 33 organizations, led by the European Patients’ Forum, with partners from patient organizations (the European Genetic Alliance, the European AIDS Treatment Group, and EURORDIS), universities and not-for-profit organizations, along with a number of pharmaceutical companies. 

Existing codes of practice for patient involvement with various stakeholders do not comprehensively cover the full scope of research and development (R&D). The European Medicines Agency (EMA) has developed a comprehensive framework of interaction with patients and consumer organizations since 2006. The EUPATI guidance documents aim to support the integration of patient involvement across the entire process of medicines research and development with regulatory agencies, health technology assessment (HTA) bodies, ethics committees and the pharmaceutical industry. Users may deviate from guidance according to specific circumstances, national legislation or the unique needs of each interaction. The guidance documents should be adapted for individual requirements using best professional judgment. 

Prior to being included in this research topic, the EUPATI guidance underwent extensive review by project members and all other consortium partners before being released for public consultation. The comments received from both rounds of review have ensured the guidance is robust and suitable for implementation.

Keywords: EUPATI, patient involvement, R&D, regulatory agency, health technology assessment

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