Personal Information
Organization / Workplace
Washington D.C. Metro Area United States
Occupation
Consumer Safety Officer-Human Subject Protection-Bioresearch Monitoring Compliance Policy Analyst
Industry
Government / Military
About
I currently draft, finalize, and coordinate the implementation of compliance policy for the Human Subject Protection-Bioresearch Monitoring (HSP-BiMo) Program within the Medical Products and Tobacco Policy Staff in the Office pf Policy and Risk Management, Office of Regulatory Affairs, for all of FDA’s six Centers (CDER, CBER, CDRH, CVM, CFSAN, and CTP). I also draft, edit, revise, and comment upon various compliance policy documents related to the HSP-BiMo Program such as Chapter 48 of the FDA’s Compliance Program Guidance Manual, specifically the sections relating to clinical investigators, nonclinical laboratories, in vivo bioequivalence, Institutional Review Boards (IRBs), sponso...
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