Project management is a professional discipline that focuses on organization and processes. Although commonly used in engineering and IT applications, project management tools and techniques can be used for better planning, organization and management of any task. The regulatory profession is well-suited for adopting project management practices; regulatory projects are usually complex, time-constrained and involve many people. Each time a new product is developed, the same global components (CMC, preclinical, clinical) are used. However, each product is unique, requiring independent methods and data generation, new solutions to unrelated issues and a distinct filing strategy. Project management techniques result in more effective use of time and resources.
This course provides students with the guidance to effectively build and maintain a regulatory development project plan, including identifying resources and determining the effort and timing required to create project and budget reports. The course also provides, from the project management perspective, important tips regarding communication and meetings, such as how to set up and run meetings as well as use them to advance and manage the project effectively.