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 AMA PRA Category 1 Credit™
    The UNC 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 activity for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
    The UNC 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 activity for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
  • 1.00 Participation

    UNC Lineberger Cancer Network certificate of participation.

    Tim Poe, Director of Telehealth

Course opens: 
04/29/2022
Course expires: 
04/28/2023
Rating: 
0
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 UNC 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 activity 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.

Available Credit

  • 1.00 AMA PRA Category 1 Credit™
    The UNC 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 activity for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
  • 1.00 AMA PRA Category 1 Credit™ - Non-physician
    The UNC 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 activity for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
  • 1.00 Participation

    UNC Lineberger Cancer Network certificate of participation.

    Tim Poe, Director of Telehealth

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