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 In this section:

                Learn About FDA Patient Engagement

Learn About FDA Patient Engagement

                        About the FDA Patient Representative Program
          When a Patient Speaks: Testimonials from FDA Patient Representatives
          How to Apply to the FDA Patient Representative Program
          FDA Patient Engagement Overview*
          FDA Patient Listening Sessions
          Patients Ask FDA
          Patients Matter Video Series
          Patient Engagement Collaborative
          Patient Engagement Cluster
          About the FDA and How You Can Get Involved


                        FDA Patient Engagement Opportunities Home
          For Patients
          Learn About FDA Patient Engagement
          Patient Engagement ClusterLearn About FDA Patient Engagement Patient Engagement Cluster
  
  	
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    PrintThe Food and Drug Administration (FDA) and the European Medicines Agency (EMA) established a workgroup in 2016 called the Patient Engagement Cluster to advance and strengthen international collaboration on patient engagement. Health Canada became official members in 2022.

The Patient Engagement Cluster joined a series of existing EMA/FDA clusters. The cluster allows FDA, EMA and Health Canada to share best practices involving patients along drug and biologic regulatory lifecycles. Information discussed by this group is covered by confidentiality agreements signed by the FDA, EMA and Health Canada.

The cluster focuses on specific topic areas where the FDA, EMA and Health Canada can benefit from a greater exchange of information and strengthen collaboration. These clusters discuss issues such as:

biosimilars
	medicines to treat cancer
	medicines for rare diseases
	medicines for children
	pharmacovigilanceThe Patient Engagement Cluster meets virtually up to four times per year. This increased interaction helps each agency:

Learn how their respective patients are engaged and involved in the work performed.
	Develop common goals of expanding future engagement activities with patients.The Patient Engagement Cluster workgroup discusses topics such as:

Ways for finding patients that appropriately speak for their community.
	Ways to ensure patients involved in agency processes directly voice the concerns of their community.
	Ways to train selected patients and advocates to effectively participate in agency activities.
	Strategies for reporting the significant impact of patient involvement.Resources For You

Learn About Patient Engagement at the FDA
	EMA: Patients and Consumers
	How Health Canada engages and informs Canadians

                                                                                  Content current as of:
      10/25/2022Learn About FDA Patient Engagement

          
                        About the FDA Patient Representative Program
          When a Patient Speaks: Testimonials from FDA Patient Representatives
          How to Apply to the FDA Patient Representative Program
          FDA Patient Engagement Overview*
          FDA Patient Listening Sessions
          Patients Ask FDA
          Patients Matter Video Series
          Patient Engagement Collaborative
          Patient Engagement Cluster
          About the FDA and How You Can Get Involved


                        FDA Patient Engagement Opportunities
 
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