Advanced Topics in Clinical Research/Drug Development

Venue: Hyatt Regency Philadelphia at Penn\'s Landing

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: Aug 21, 2006 End Date/Time: Aug 23, 2006
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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.

Venue

201 S Christopher Columbus Blvd
Philadelphia
Pennsylvania
United States
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