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                FDA Meetings, Conferences and Workshops

FDA Meetings, Conferences and Workshops

                        FDA Meetings, Conferences, and Workshops: Past Events
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          FDA Meetings, Conferences and Workshops
          Clinical Trials: The Patient Experience - 04/13/2023FDA Meetings, Conferences and Workshops Workshop
    Event Title
              Clinical Trials: The Patient Experience


                  April 13, 2023

  

    
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      Meeting Information
                Event MaterialsDate:
          
  


     
           

April 13, 2023   

 
 
        
                                      Time: 
                                      
11:00 AM
    - 3:00 PM
ET

 

  The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a public virtual workshop on Thursday, April 13, from 11:00 a.m. – 3:00 p.m. ET.

The workshop, Clinical Trials: The Patient Experience, featured a panel of rare disease patients, caregivers, and advocates who shared their experiences with gene therapy clinical trials. Through participation in clinical trials, patients can help advance the science of gene therapy and further the development of rare disease treatments.

FDA CBER OTP Gene Therapy Clinical Trials Workshop
Event Details

The workshop featured a variety of rare disease patients, caregivers, and advocates to discuss:

The experience of finding and participating in gene therapy clinical trials as both a patient and a caregiver
	The risks and benefits of participating in a gene therapy clinical trial
	How the FDA works to ensure that gene therapy clinical trials are as safe as possible for patientsView a recording of the workshop here.

What Is Regenerative Medicine?

Regenerative medicine therapies, such as cell and gene therapies, hold promise for transforming medicine and creating options for patients living with difficult, rare, and often incurable diseases. The FDA plays a vital role in facilitating the development of regenerative medicine therapies, as well as in ensuring approved products are safe and effective for patients.

About the RegenMedEd Series

This is the third annual patient engagement workshop hosted by FDA CBER OTP. You can access previous workshop materials, including event recordings and transcripts, here:

Patient Engagement & Regenerative Medicine: An FDA CBER Workshop for Patient Advocates(2021)
	Annual Patient Engagement & Regenerative Medicine Meeting: An FDA CBER Workshop for Patient Advocates (2022)This workshop was part of an educational series, RegenMedEd: An FDA CBER OTP Series on Regenerative Medicine. The RegenMedEd series aims to bring together important stakeholders and FDA staff to discuss foundational information about regenerative medicine therapies, such as gene therapy and cell therapy products, and explore opportunities for patients, caregivers, and advocates to engage with FDA to help advance drug development.





Event Materials

  Title
            File Type/SizeSlides - Clinical Trials: The Patient Experience
              pdf               (4.81 MB)Transcript - Clinical Trials: The Patient Experience
              pdf               (546.30 KB)

                                                                                  Content current as of:
      07/21/2023
         
                   
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		 BiologicsMore Meetings,
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        FDA Meetings, Conferences and Workshops

          
                        FDA Meetings, Conferences, and Workshops: Past Events
          FDA Annual Reports on Conferences


                        Public Calendar - Meetings With FDA Officials
 
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