Advanced Topics in Clinical Research/Drug Development

Venue: Park Hyatt Philadelphia at the Bellevue

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: May 07, 2007 End Date/Time: May 09, 2007
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Description

This course reviews the drug development process for new therapeutic agents and the management of clinical programs through interactive lecture and hands-on workshops. Topics addressed include product development plans, clinical trial process, and quality concepts.

KEY TOPICS
•Product development plan: target product profile, multinational studies and industry challenges.
•Clinical trial processes: protocol development, data collection methods, informed consent challenges, study reports and NDA/CTD.
•Quality concepts: site management and auditing.

Venue

Broad and Walnut Streets
Philadelphia
Pennsylvania
United States
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