FDA and European Medicines Agency Patient Engagement Cluster
The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have created a new workgroup on patient engagement called the FDA/EMA Patient Engagement Cluster.
The FDA/EMA Patient Engagement cluster joins a series of currently existing EMA/FDA clusters
. The cluster allows FDA and EMA to share best practices involving patients along drug and biologic regulatory lifecycles. Information that is discussed is covered by confidentiality agreements signed by the FDA and EMA.
The clusters will focus on specific topic areas where the FDA and EMA can benefit from a greater exchange of information and strengthen collaboration. These clusters discuss issues related to:
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biosimilars
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medicines to treat cancer
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orphan medicines
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medicines for children
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pharmacovigilance
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among other topics
The new cluster work group will meet up to four times per year by telephone. This increased interaction will help each agency:
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Learn how their respective patients are engaged and involved in the work performed.
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Develop common goals of expanding future engagement activities with patients.
The FDA/EMA Patient Engagement cluster workgroup will discuss:
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Ways for finding patients that appropriately speak for their community.
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Ways to ensure that patients involved in agency processes directly voice the concerns of their community.
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Ways to train selected patients and advocates to effectively participate in agency activities.
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Strategies for reporting the significant impact of patient involvement.
The launch of this cluster is the latest step in FDA and EMA’s broadened approach to advance and strengthen international collaboration.