Project Management for Regulatory Professionals

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.

  • At A Glance
  • Learning Objectives
  • Lesson Titles
  • Learning Activity
  • Registration Options

At A Glance

  • Target Audience: This course is designed for new and experienced regulatory personnel interested in learning and improving project organization and management skills.
  • Learning Level: Basic, Intermediate
  • Total Length of Course: 4–8 Hours
  • RAC Credits: 4
  • Formats: PC and Tablet (iPad and Android)
  • Cost: Member $455; List $630
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Learning Objectives

Upon completion of this course, participants should be able to:

  • Outline how to incorporate project planning tools throughout the product development lifecycle
  • Discuss how to optimize team performance, communication and interaction
  • Develop communication methods and tools for information dissemination by type of stakeholder: teams, management and individuals
  • Define variance, estimate at completion and earned value, and explain why they are important project reporting metrics
  • Assign resources to tasks in the project plan and estimate the effort and time needed to accomplish a task
  • Identify ways to incorporate quality planning into a project

Lesson Titles

  • Lesson 1: Project Planning Basics––A Strategic Approach
  • Lesson 2: Resource Planning, Estimating and the Project Budget
  • Lesson 3: Communication and Meetings
  • Lesson 4: Metrics and Reporting
  • Lesson 5: Making the Project Team Effective

Learning Activity


This scenario-based activity lets you practice your regulatory decision-making in a safe and interesting way. Follow the events of a hypothetical story, gain important background information and hear stakeholder opinions before having to make choices about various regulatory issues. Then, see how those choices impact the story, company, product and characters. Complete this activity multiple times and see how things can change when you vary even one of your choices.

Registration Options

This course is available for purchase as follows: