Module 6

04/10/2024

Role of Patient Organisations in Drug Development

To pharmaceutical companies • Provide real-life perspective on their disease area to better understand their needs • Motivate employees • Shape the environment • Politically, scientifically, reimbursement matters • Disease awareness • Input into choice of endpoints in clinical studies • Need for transparency

Examples of company position of engagement with patients

GSK: https://www.gsk.com/media/8836/gsk-position-on-engagement-with-patient organisations-may-2022-1.pdf

Pfizer: https://www.pfizer.co.uk/responsibility/transparency/patient-organisation-funding and-support

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Role of Patient Organisations in Drug Development

To EMA

The framework of EMA’s interaction with patients’ and consumers’ organisations was originally adopted by EMA’s Management Board in 2005, it was updated in 2022 EMA has a Patients’ and Consumers’ Working Party (PCWP) established which provides a platform for exchange of information and discussion of issues of common interest between EMA and patients and consumers. Patients and consumers are involved in a wide range of activities at the Agency, including: • as members of the Management Board and of scientific committees • being consulted on disease-specific requests by the scientific committees and working parties • taking part in discussions on the development and authorisation of medicines • reviewing written information on medicines prepared by the Agency (PL, EPAR summaries) • being involved in the preparation of guidelines • taking part in the Agency's conferences and workshops EMA publishes abiennial report on its interactions with patients, consumers, healthcare professionals, academics and their organisations

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