The report is the result of four years of work with patient group leaders, academics, industry experts, regulators and other stakeholders, and EMA is pleased to have been involved.
Patients are at the centre of modern healthcare and their engagement is critical to ensure the sustainable development and safe use of medicine.
The report is available here: https://lnkd.in/eekeWgcR
This report describes the importance of systematically involving patients throughout a medicine’s life – from its early development through the regulatory process to ongoing monitoring and safe use in everyday healthcare. It provides a comprehensive overview of the current knowledge about the benefits of patient involvement and existing initiatives, gives many examples and recommendations, and addresses the remaining challenges and practice gaps. The report will prompt readers to implement its best practice recommendations according to how well they fit in with their organisational and national needs.
The report combines the experience and expertise of the CIOMS Working Group XI on Patient involvement in the development, regulation and safe use of medicines. It also incorporates views gathered from an open meeting in Switzerland and a workshop in Uganda, which both brought together members of the public, patient organization representatives, regulators, drug development experts, industry, academia, health professionals and other related stakeholders. The report was finalised following a public consultation. CIOMS is an international, non-governmental, non-profit organization with the mission to advance public health through guidance on health research and policy including ethics, medical product development and pharmacovigilance.