This course reviews the identification and development of new therapeutic agents and the management of clinical development programs through interactive lecture and hands-on workshop training methods. Topics addressed include industry challenges, clinical operations, key documents, and quality concepts. The content for this course focuses on drugs and biologics development.

Key Topics
Industry challenges: product identification and development, multinational studies.
Clinical operations: clinical process overview, project and resource management, ethics/HIPAA.
Key documents: protocol development, CRFs/data collection devices, study reports, NDA/CTD preparation.
Quality concepts: study management and auditing.