Speaker Profile
Janet Ellen Holwell

Janet Ellen Holwell CCRC, CCRA, TICAR, FACRF

Research and Clinical Research
Alexandria, Virginia, United States of America

Connect with the speaker?

Janet Ellen Holwell is an independent consultant specializing in maximizing excellence in CGP quality, compliance, and training for both sites and the industry. She works contractually with sponsors, CROs, academic medical centers, site investigators, and their personnel to provide training and mentoring in the clinical research process, specializing in ICH-GCP compliance and quality oversight. She prepares clients for inspections/audits as well as helps them write effective CAPAs and SOPs, develop quality plans and create internal QA processes.

Ms. Holwell began her career as a clinical research coordinator in academia over 30 years ago. Prior to transitioning to industry, she managed a clinical pharmacology unit at Columbia Presbyterian Medical Center in New York City overseeing all operations. She was an instructor in good clinical practice (GCP) and helped develop the first GCP program in an academic institution. Prior to her position in quality management with Pfizer, she held positions as a clinical research associate, site selection specialist, study manager with oversight of vendor CRAs, clinical operations quality lead, and trainer for several pharmaceutical companies.
EVENTS & ACTIVITIES (Speaking, Spoken, and Authored)