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Todd Kisner

Vice President
Quality & Regulatory Affairs
Bioclinica
United States of America

Biography

Todd Kisner is a recognized clinical research industry senior executive with more than 20 years of experience in the pharmaceutical and technical industries. As the Vice President, Quality Assurance and Regulatory Compliance, he oversees the Corporate Quality Management System, Regulatory Compliance and Records Management groups at Bioclinica. He holds responsibility for ensuring Bioclinica and its products and services comply with international regulatory standards, industry best-practices and leads retrospective oversight activities. Todd has held numerous positions of increasing responsibility and joined Bioclinica as the Vice President of Quality and Regulatory Affairs in 2013. Prior to joining the Company he was responsible for Quality Assurance and Regulatory Compliance with CoreLab Partners and the Director of Quality Assurance with Medifacts International. Todd has held key validation and technical roles at SAS Institute and Thomson Reuters. Additionally he has been a contributor to the Metrics Champion Consortium for both ECG and Imaging, and has extensive experience in data privacy regulation, 21 CFR Part 11, GxP, Quality Assurance, SDLC and Validation Services. He holds an organizational excellence ASQ certification and sits on industry Global Data Protection and Privacy Committees, Ethics & Regulatory Compliance Committees, and GCP Quality Management System work streams.

Research Interest

Clinical Research, Regulatory Affairs, Quality Control, Quality Assurance Regulatory Compliance and Records Management, Healthcare, Pharmaceutical Industry

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