Project Management for Phase 1 & 2 Clinical Trials
June 25 - 26, 2012 - Los Angeles PA US
Center for Professional Innovation and Education, Inc.
Phone: (610) 688-1708
Efficient and effective management of Phase 1 and 2 clinical trials can significantly impact the time, scope and budget for the development of a drug or device. Project managers must understand the development process and the key aspects of Phase 1 and 2 in order to act, react, and adapt to change when the program moves forward and new data is acquired. Successful completion of Phase 1 and Phase 2 clinical trials are key project milestones. This course focuses on the best practices for developing and managing these trials within GCP guidelines and FDA regulations. The course will discuss the challenges associated with clinical trials run outside the United States and identify key differences, common pitfalls, and cultural challenges. Guidance for the “how-to” will be provided, along with problem solving for specific situations such as slow enrollment, high screen failures, or issues with data quality. The course is interactive and designed to allow for the exchange of ideas between peers in addition to learning from the instructor.