Janet C. Donnelly, RAC

Policy Analyst, Office of Good Clinical Practice
FDA

Janet Donnelly, RAC is a Policy Analyst in FDA’s Office of Good Clinical Practice. The Office of Good Clinical Practice is a focal point within FDA for Good Clinical Practice (GCP) and Human Subject Protection (HSP) issues arising in human studies regulated by FDA. Within the GCP office, 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 to the IRB and external clients.

Presentation(s):

• A21 - An Introduction to the FDA and Their Regulations for the Non-Scientist IRB Member

  Monday, November 18
  1:00 PM – 2:15 PM

• E07 - Essential Documentation—IRB Record Keeping, Written Procedures, Minutes, and More

  Wednesday, November 20
  11:30 AM – 12:45 PM