PTI - international

Agenda: Day One

• Outline scope and agenda for the course
• Review late-stage drug development process (Phase III, Commercialization, "Phase IV")
• Review key project management concepts and terms

Exercise: Determine Participants' Backgrounds and Identify Common Course Goals

II. Phase III: The Project Team

• Determine which departments and or disciplines should be represented (for example CROs, Contract Manufacturer, Contract Laboratory, Manufacturing Facilities, etc.)
• Communicate with stakeholders (the project team, project sub-teams, management, intra-organizational partners, key opinion leaders)

Exercise: Develop Roles/Responsibilities Matrix for Project Team Members
Exercise: Review Example of Communication Plan

III. Phase III: Updating the Target Product Profile

• Identify what has changed from the original TPP
• Identify what factors must be considered (earlier phase data, regulatory issues, the changing marketplace, the voice of the customer)

Exercise: Critique a Sample Target Product Profile

IV. Phase III: Developing Project Objectives

• Examine typical objectives of a Phase III project
• Prioritize objectives
• Identify strengths and opportunities

V. Phase III: Developing the Project Plan

• Develop the Work Breakdown Structure
  • identifying activities
  • sequencing activities
  • identifying the critical path
• Resource the plan
  • identifying resource needs
  • negotiating for resources
• Manage risks 
  • identify weaknesses and threats

VI. Phase III:  Developing a Timeline and Budget for Meeting Project Objectives

• Create timeline 
  • time: balancing what you need against what you can get
  • tools for developing timelines
  • tools for tracking timelines
• Work with the budget
  • budget: balancing what you need against what you can get
  • tools for developing budget
  • tools for tracking budgets
    

Exercise: Create a Project Timeline Given a Sample Scenario

VII. Phase III: Project Implementation, Monitoring and Control

• Outline the decision making process
• Utilize monitoring tools
• Assure quality and prevent quality control issues during scale up
• Communicate progress

Exercise: Compile a Master-List of Critical Decision-Making Criteria