Janet Donnelly, RAC

FDA
Silver Spring, MD

Janet Donnelly, RAC is a Regulatory Policy Advisor in FDA’s Office of Clinical Policy (OCLiP). 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 five years of experience in regulatory affairs and regulatory compliance in the sponsor, CRO and independent IRB settings. Prior to joining FDA in 2008, Janet served as Director of Compliance for an independent IRB providing regulatory consultation.

Presentation(s):

• E09 - [IN-PERSON ONLY] Zen and the Art of IRB Meeting Minutes

  Tuesday, December 5, 2023
  4:00 PM – 5:00 PM ET

• H02 - [IN-PERSON/RECORDED] OHRP, FDA, and the General Accountability Office (GAO) Report on IRB Oversight and Effectiveness: A Conversation With the PRIM&R Community

  Wednesday, December 6, 2023
  1:45 PM – 2:45 PM ET