Phyllis B. Kent:
President of Kent Associates Inc. a clinical quality assurance consulting firm specializing in training, auditing, and preparation for FDA inspections. Since 1992, Kent Associates, Inc. has been providing training and consulting services to pharmaceutical, biotech, device and consumer healthcare companies. Previously, Ms. Kent headed Clinical Quality Assurance for R.W. Johnson Pharmaceutical Institute, and was responsible for directing the auditing of all aspects of the clinical research process and NDA submission. Prior to joining Ortho/R.W. Johnson PRI, Ms. Kent was an investigator for the Food and Drug Administration for 10 years in the Newark District Office, specializing in drug and device inspections covering Good Clinical Practices, GMPs, and GLPs. Her experience in the bioresearch area includes sponsor/monitor, clinical investigator and IRB inspections. Ms. Kent performed overseas inspections as part of FDA’s foreign inspections program and was a lecturer at FDA national training programs. Ms. Kent was a founding member of the NJ/PA/DE Clinical Quality Assurance Discussion Group. In addition to in- house training for clients on Basic and Advanced GCPs, Fraud and Scientific Misconduct, and Preparation for FDA Inspection, Ms. Kent has lectured at the PhRMA (PERI) GCP courses and has made numerous presentations at DIA, SQA, SoCRA and PhRMA meetings. She is a member of the Drug Information Association and is past chair of the PhRMA Bioresearch Monitoring Subcommittee.