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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![]() | Kaitlin Morrison, PhD Director of UNC Lineberger Sponsored Clinical Research |
Presenter Disclosure Information
The presenter has 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.
1.00 General Participation Credit
UNC Lineberger Cancer Network certificate of participation.
Available Credit
- 1.00 Participation