The field of gene therapy is quickly growing in the United States and around the world as the US FDA and regulatory agencies at several other countries have begun issuing approvals for licensed gene therapy products. Clinical trials involving human gene transfer are becoming increasingly common, not just at large academic medical centers, but 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 receiving federal funds or taking place at sites receiving federal funds, federal requirements call for review by both an IRB and an IBC prior to registering with the National Institutes of Health (NIH). Further review may be required by the NIH Recombinant DNA Advisory Committee (RAC).
In this webinar, Advarra’s Director of Biosafety Services Daniel Eisenman, PhD, RBP, SM(NRCM), CBSP, will discuss the basics of research involving genetic engineering and the role played by the IBC in ensuring research is conducted safely and responsibly.
In this free webinar, we will:
- Define the federal requirements and oversight structure governing research involving human gene transfer including recombinant DNA and synthetic nucleic acid technology
- Explain the role and functions of the IBC
- Describe the types of studies which might require IBC review
- Discuss how to prepare for IBC review
Who Should Attend: Anyone seeking an introduction to the science and regulatory oversight of research involving the delivery of modified genetic material to study participants, including representatives from:
- Research sites
Certificates of attendance are available for this event. The presentation may qualify for continuing education credits; check with your certifying organization(s) for more information.
Thursday, July 19th
Presentation: 2:00-3:00pm ET
Q&A: 3:00-3:15pm ET