It is crucial to utilize project management knowledge and tools for effective and efficient clinical trial management in drug development. Utilization of project management knowledge and tools in some pharmaceutical companies has been well established, and it has been demonstrated that project management can help shorten the development timeline, improve quality, and optimize cost/resources.
Ten years have passed since the law changed in relation to investigator inititated clinical studies. Environmental sites, such as SOP and CRA training, have been more prioritized than the implementation of project management processes and tools. With better understanding of project management concepts and tools, it would become more efficient and effective to translate research questions into practical clinical study design, planning, implementation and publication.
This project management basic training program, which is specifically developed by DIA’s project management group, is focused on the people involved in clinical trials, especially investigator initiated trials at clinical sites.
You will learn how to utilize project management concepts and tools in your own clinical studies for project planning document creation, clinical protocol development, and study
We hope this training will provide an opportunity for clinical investigators, site study managers, clinical trial offices at clinical sites, etc., to learn basic project management concepts for effective and efficient clinical study management.
• To learn and implement important tools and processes of project management focused on clinical study
• To learn practical project management concepts with examples of investigator initiated clinical studies
• To enjoy the interactive format of the training program and network building
PROGRAM AGENDA [JAPANESE LANGUAGE ONLY]
THURSDAY, JULY 10, 2014
9:30-10:00 Introduction, Ice breaker
10:00-11:00 What is project management?
11:15-12:15 Initiation process
12:15-13:15 Lunch break
13:15-15:00 Scheduling – planning clinical study
15:15-17:00 Project stakeholder management
17:00-17:30 Project closure – lessons learned
17:30-18:00 Q&A for actual implementation
18:00-19:30 Networking Reception