Carol Holquist, R.Ph.
Vice President Global Naming, Labeling & Human Factors

Ms. Holquist joined DSI – Rockville in 2017 as Vice President, Global Naming, Labeling and Human Factors. Prior to joining DSI, Ms. Holquist recently retired as Deputy Director of the Office of Regulatory Operations in the Office of Generic Drugs at the Food and Drug Administration (FDA), Center for Drug Evaluation & Research (CDER). She was responsible for the final evaluation and approval of all abbreviated new drug applications (ANDAs). She has 24 years of FDA experience, 14 of which are in the field of medication error prevention. For 9 years she was Division Director, 2 years as Deputy Director, and 3 years as Safety Evaluator for the Division of Medication Error Prevention and Analysis (DMEPA) in OMEPRM, CDER, FDA. She was responsible for the final approval of manufacturer’s drug/biologic brand names, and human factors/medication error evaluation of drug/device labeling, packaging, and product design to reduce medication errors.

She has co-authored numerous articles and several key medication error prevention guidance’s including FDA’s Contents of a Complete Submission for Proprietary Names Guidance (2010), Safety Considerations for Container Labels and Carton Labeling (2013), and Safety Considerations for Proprietary Names (in clearance for 2013) to name a few. She oversaw DMEPA Regulatory Briefings to inform FDA Senior Management on medication safety issues, led pre-and post-marketing negotiations of proprietary name and labeling changes, human factors studies, and coordinated DMEPA related responses to name decisions, rejections and approvals. She represented FDA nationally as a member of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), U.S. Pharmacopeia Safe Medication Use Expert Committee (SMU) and CDER’s Labeling and Nomenclature Committee. Internationally, she represented FDA as an expert Advisor to Health Canada regarding the Review of Health Product Names for LASA Confusability: Development of a Guidance for Industry and a HC SOP.

Ms. Holquist earned her B.S. in Pharmacy from Temple University.




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