CRED ERP 25
01/07/2025
Patient involvement at EMA
⚫ Activities:
⚫ Patients and consumers are involved in a wide range of activities:
• as members of the Management Board
• as members of scientific committees (COMP, PDCO, PRAC)
as members in MSSG
•
• participation in SA meetings / 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 (package leaflets, EPAR summaries)
• Involvement in the preparation of guidelines
• Taking part in the Agency’s conferences and workshops e.g. on shortages
NB: check ongoing EMA’s activities related to Patient experience data in medicines development and regulatory decision-making
The Organisation for Professionals in Regulatory Affairs 67
67
⚫ Recap
The Organisation for Professionals in Regulatory Affairs 68
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