INFO 7420 — Drug Development Processes and Information Systems Compliance
4 semester hoursGraduateLecture
Explores many of today’s most pressing and challenging IT questions facing the pharmaceutical/biotechnology industry and the FDA regarding the use of electronic records, databases, and information management systems that have become an integral part of development programs and regulatory submissions. Begins with the recognition that information technology has transformed the way that new drugs are developed today. From preclinical studies to small phase 1 clinical trials, all the way up to large global phase 3 pivotal trials, virtually every aspect of drug development is evolving due to technological advances. Each of these advances carries with it technological, procedural, and regulatory challenges and uncertainties.