University of California, Berkeley - Extension

The Drug Development Process: An Intensive Seminar

The seminar examines the complex, interrelated activities involved in bringing pharmaceutical discoveries to approval and market, while also incorporating biologics, diagnostics, and medical devices. Topics include the industry environment; drug discovery and pharmacology; chemistry, manufacturing and controls (CMC); toxicology; pharmacokinetics; program management; FDA inspections and compliance; biologics; assays and devices; clinical-trial design, conduct, monitoring, and statistics; pharmacogenomics; patents and intellectual property; postmarketing surveillance; and commercial development. Discussions are guided by experts with hands-on experience in pharmaceutical, biotechnology, and related companies. The course is designed for executives, disciplinary experts, nontechnical professionals, investors, and others interested in the biopharmaceutical industry.