| Description |
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.
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