“The Added Value of Patient Engagement in Early Dialogue at the European Medicines Agency (EMA): Scientific Advice as a Case Study”, Frontiers in Medicine
ABSTRACT The European Medicines Agency provides Scientific Advice to medicines developers and patient input has been an integral part of this process for many years. As end users of medicines, patients bring their perspectives to many different processes along EMA’s regulatory pathway, complementing the scientific expertise. While the value of including patients has been
The European Medicines Agency (EMA) updates its engagement framework with patients, consumers and their organisations
The European Medicines Agency (EMA) engagement framework aims to Facilitate participation of patients and consumers in regulatory activities all along the entire lifecycle of medicines; Foster the development of guidance and methodologies to increase collection and use of relevant patient experience data in the context of regulatory decision making; Ensure that patients, consumers and their