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Preconference Workshop: Project Management in Global Regulatory Affairs for Product Lifecycle Maintenance

Tuesday, March 5, 2024
9:00 AM – 4:00 PM East Coast USA Time
Location: Concourse C
This workshop requires an extra registration fee.

The approach to Project Management in Regulatory Affairs is heavily focused on new product development, leaving lifecycle maintenance activities often overlooked. The purpose of this workshop is to provide regulatory affairs professionals that conduct product lifecycle maintenance activities such as renewals, changes, and updates in regulations, with a basic understanding of project management and the mindset needed to conduct a mid to large-scale project with global impact. Three case studies will be covered, providing participants with the opportunity to interact and apply the concepts provided throughout the workshop.

Agenda Outline:

9:00-9:15 am Review workshop goals and agenda
9:15-10:00 am Defining Project Management and the Role of the Project Manager
10:00-12 noon Overview of Project Management principles
12 noon-1:00pm Lunch
1:00-1:45 pm Project Management Tools and Templates
1:45-3:15 pm Rotating Breakout Sessions (renewals, changes, new regulations)
3:15-3:45 pm Debrief and Discussion
3:45-4:00 pm Q&A

Learning Objectives:

  • Understand the principles of project management and learn how project management can be scaled to support product lifecycle maintenance activities
  • Learn how to use intermediate to advanced tools/concepts to support project management activities and learn how to select tools to match project/team nee
  • Understand when and how to exhibit PM behavior traits in RA activitie