ACRP Journal Club – April 2020
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Topic: Understanding Regulatory Guidance for Gene Therapy Development
(ACRP2019 Replay, session 210)
Program Agenda:
12:30pm- 1:30pm
Description
It has been a big year for gene therapy. In the past 12 months, three gene therapy products received approval from FDA. In July 2018, FDA Commissioner Scott Gottlieb released a statement on the FDA’s efforts and commitment to advance gene therapy. The statement included the announcement of six new or revised guidance documents related to the development of gene therapy products. In this presentation, Dr. Vaughn will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for clinical development of new gene therapy products.
Learning Objectives:
- Identify the six new draft guidance documents recently released by the FDA in the area of gene therapy.
- Understand the basic recommendations the FDA has for sponsors and researchers working in the area of gene therapy.
- Describe general differences between the development of gene therapy products and traditional pharmaceutical products.
Speaker(s):
Target Audience:
- CRCs
- CRAs
- Investigators
- Auditors
- Regulatory Affairs/Compliance
- Quality Assurance
- Clinical Research Administrators
Registration Cost: FREE to all Chapter, ACRP, and non-members
Contact hours: 1.0 Contact hours have been applied for through ACRP.
Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program. Log on to the ACRP website then “My Courses” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
Site Refund Policy: Not applicable