Preparing for Multisite Gene Therapy Studies

The dramatic growth of the gene therapy is unprecedented, as the U.S. Food and Drug Administration (FDA) and other international regulatory agencies have begun issuing approvals for licensed gene therapy products.

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 both institutional review board (IRB) and institutional biosafety committee (IBC) review.

In this webinar, you’ll learn the basics of preparing for gene therapy research and the IBC’s role in ensuring safe and responsible research.

Learning Objectives

Following this webinar, attendees will be able to:

Define 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 requiring IBC review
Describe how to prepare for IBC review
Identify the benefits of centralized IBC review of multisite gene therapy studies

Learning Objectives

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

Presented By

Daniel Eisenman

PhD, RBP, SM (NRCM), CBSP

Director of Biosafety Services
Advarra

Not in use

Not in use
Not in use

Who Should Watch?

Content applies to sponsors, CROs, research sites, institutions, and IRB members.

CEU Credits

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.

This session meets the Certified IRB Professional (CIP) recertification guidelines for a maximum of 1 credit.

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.