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.
PhD, RBP, SM (NRCM), CBSP
Director of Biosafety Services
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. 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. Information for CE credits for SOCRA can be found on socra.org.
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