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Preparing for Multisite Gene Therapy Studies
The fast and dramatic growth in the field of gene therapy is unprecedented, as the US FDA and regulatory agencies of several other countries have begun issuing approvals for licensed gene therapy products.
The regulatory environment has also evolved to accommodate the boom in growth.
Clinical trials involving human gene transfer are beginning to spike, not just at large academic medical centers but also at smaller clinical research sites. The field is growing particularly fast in oncology, infectious diseases, and diseases caused by a single defective gene. For human gene transfer studies that receive federal funds or take place at sites receiving federal funds, federal requirements call for review by both an IRB and an IBC prior to registering with the NIH.
In this webinar, Daniel Eisenman, Director of Biosafety Services for Advarra, will discuss the basics of how to prepare gene therapy research and the benefits of centralized review for multisite gene therapy studies. He will also explain the IBC’s role in ensuring research is conducted safely and responsibly.
Following this free webinar, attendees will be able to:
- Define the federal requirements and oversight structure governing gene therapy research involving recombinant DNA and synthetic nucleic acid technology
- Explain the role and functions of the IBC, including types of studies which may require IBC review
- Describe how to prepare for IBC review
- Identify the benefits of centralized review of multisite gene therapy studies through externally administered IBCs
PhD, RBP, SM (NRCM), CBSP
Director of Biosafety Services
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Who Should Watch?
Content applies to sponsors, CROs, research sites, institutions, and IRB members.
Attendance at this session has been approved for 1.00 contact hour of research specific continuing education on applications for Maintenance of ACRP’s CCRC®, CCRA®, CPI®, or ACRP-CP® certification designations and 1 hour of continuing education credit for the Certified IRB Professional (CIP) certification. The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit. If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements.
Certificate of Attendance
After completing this webinar in its entirety, you will receive a certificate of attendance. This certificate will include your full name, and it will be emailed to you at the end of the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and take the survey at the end. Visit our Webinar Help page for more information on certificates of attendance.
Duration: 1 hour