With the drug development process becoming increasingly more competitive, complex, and global, it is necessary for clinical research professionals to clearly understand their role, and the role of others with whom they interact, to help facilitate a drug development process that is both timely and completed within budget.
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.
COURSE HIGHLIGHTS
•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.
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.
COURSE HIGHLIGHTS
•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.
