| Caroline LaPlaca is a pharmaceutical professional with a unique combination of regulatory and clinical experience gained over 30+ years in regulated industry (GLP/GCP) with 20+ years in clinical operations at both start-up and established companies, including CROs. Her primary expertise is in clinical project/ program management with a quality focus and includes experience with small molecules and biologics across multiple therapeutic areas and phases of clinical development. Her career includes establishing and implementing an internal departmental Quality Assurance/GCP Compliance program as well as external GCP-audit programs for vendors and clinical sites at several different biotech companies. In addition, Caroline was a member of the Editorial Board, Chapter Chair, and contributing author for “Computerized Systems in Clinical Research: Current Quality and Data Integrity Concepts” (AKA the Drug Information Association “Peach Book”, a global collaborative project); June 2011 release; ISBN# 978-1-4507-7152. She has also been an invited speaker at the DIA 47th Annual Meeting (June 2011) presenting on GCP compliance in due diligence activities, and has been an invited instructor for the University of Medicine and Dentistry of New Jersey School of Health Related Professions Biopharma Educational Initiative. Course Number BPHE6700, “Special Topics in Clinical Trial Sciences”. |