Advanced Topics in Clinical Research/Drug Development
|Event Date/Time: Nov 19, 2007|
Through interactive lectures and hands-on exercises and simulations, this course will provide clinical research professionals with the knowledge and skill set needed to improve the drug development process. Topics to be addressed include; product development strategy, clinical trial management and development, project management, and quality concepts.
•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.