Commonly used in engineering and information technology applications, project management principles, tools and techniques also can be used for better planning, control, monitoring and review of project tasks in the regulatory profession. The regulatory profession is well-suited for adopting project management practices; regulatory projects are usually complex, time-constrained and resource-intensive. Although product development encompasses the same global components (chemistry, manufacturing and controls [CMC], nonclinical, clinical), each product is unique, requiring the manufacturer to generate data and/or methods, respond to specialized issues and create an individualized domestic and/or global filing strategy. Effective implementation of project management principles results in a more efficient use of time and resources.
This course provides guidance for effectively establishing 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 a project management perspective, important tips on communication methods and tools for information dissemination, such as how to set up and conduct meetings and how to use meetings to advance and monitor the project effectively.