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Charma A. Konnor, R.PH., RAC, Executive Director/Consultant,
Devices and Drugs, has had over 25 years of experience with the Food and Drug
Administration (FDA) directing regulatory and compliance activities. She
received numerous FDA awards for her leadership and improvements in pharmaceutical
and device programs. While in the Center for Devices and Radiological Health
(CDRH), she was Director of the Division of Bioresearch Monitoring (BIMO), where
she initiated significant improvements in bioresearch monitoring of preclinical
and clinical device trials (GCPs), Application Integrity Policy (AIP) implementation,
and enforcement of the promotion of investigational devices.
Prior to her tenure with CDRH, Ms. Konnor was, for an extended period
of time, Acting Director of the Office of Compliance
in the Center for Drug Evaluation and Research (CDER).
In her position at CDER, she had senior executive responsibility
for programs and enforcement that included drug product
quality and manufacturing, labeling, marketing and distribution,
surveillance, registration and listing. She also was
Director of the Division of Prescription Drug Compliance
and acting Director of FDA's Florida District Office.
In earlier years, she was an OTC drug reviewer, health
policy staff deputy in the Commissioner's Office, and
director of the FDA-USP compendial standards liaison
staff. She also practiced clinical pharmacy.
Ms. Konnor is certified in Regulatory Affairs and has a Pharmacy degree from
Wayne State University, where she graduated at the top of her Pharmacy class.
She has active Pharmacist licenses in Virginia and Michigan. She serves on the
editorial boards for Guide to Good Clinical Practice and BioResearch
Compliance Report.
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