FDA
Silver Spring, MD
Janet Donnelly, RAC is a Regulatory Policy Advisor in FDA’s Office of Clinical Policy, Good Clinical Practice (OCLiP/GCP). This office is a focal point within FDA for Good Clinical Practice (GCP) and Human Subject Protection (HSP) issues arising in human studies regulated by FDA. Janet assists in the development and revision of regulations, policy, and guidance, and serves as a resource to a variety of internal and external stakeholders on GCP and HSP issues.
Janet brings thirty years of experience to FDA in regulatory affairs and regulatory compliance in the sponsor, CRO and independent IRB settings. Prior to joining FDA, Janet served as Director of Compliance for an independent IRB providing regulatory consultation.
Disclosure information not submitted.
B06 - Essential Documentation: IRB Record Keeping, Written Procedures, Minutes, and More
Wednesday, November 17, 2021
1:45 PM – 2:45 PM ET