Gene Therapy- FDA and Local Considerations

Course Description

In this talk, which was presented to FDA, IRBs and study teams throughout the US, Kaitlin Morrison, PhD takes you through gene therapy trials and what you need to know about them beyond your typical IIT process. This includes insights into specific protocol requirements and additional review bodies that will oversee your study.

Learning Objectives

  • Learning how manufacturing limitations play into clinical operations.
  • Learning techniques to educate patients on complicated gene therapy concepts.
  • Learning techniques to succeed in gene therapy regulatory reviews.

Taking the Course

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Course summary
Available credit: 
  • 1.00 Participation
Course opens: 
Course expires: 
Photo of Kaitlin Morrison, PhD 

Kaitlin Morrison, PhD

Director of UNC Lineberger Sponsored Clinical Research
Assistant Professor of Medicine, Division of Hematology

UNC Lineberger Sponsored Clinical Research
UNC Lineberger Comprehensive Cancer Center
UNC School of Medicine
University of North Carolina at Chapel Hill


Presenter Disclosure Information

The presenter has no relevant financial relationships with ineligible companies as defined by the ACCME.

This activity has been planned and implemented under the sole supervision of the Course Director, William A Wood, MD, MPH, in association with the UNC Office of Continuing Professional Development (CPD). The course director and CPD staff have no relevant financial relationships with ineligible companies as defined by the ACCME.



The following accrediting agencies have approved this course for continuing education credits. Participants should understand that their individual participation and claiming credit must abide by the regulations set forth by their respective accrediting agency.

**CME credits available for UNC personnel only**

1.00 AMA PRA Category 1 Credit™
The School of Medicine of the University of North Carolina at Chapel Hill is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.The School of Medicine of The University of North Carolina at Chapel Hill designates this internet enduring material for a maximum of 1.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

1.00 General Participation Credit
UNC Lineberger Cancer Network certificate of participation.

Available Credit

  • 1.00 Participation
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