PTI - international

Agenda: Day One

Review the Course Brochure for Full, Detailed Information.

I. Introduction to Project Management and Drug Development

• The long road from molecule to market
• Challenges faced by pharmaceutical companies
• Phases of drug development, with focus on:
  • discovery
  • preclinical

Exercise: Discussion on the Challenges of Establishing a Drug Devlopment State Gate Process

II. Discovery: Project Team

• Project authorization
• Forming a discovery project team
• Developing a project charter
• Project team needs:
  • infrastructure
  • team members
  • communication
  • meetings
    

Exercise: Discussion on the Role of the Project Leader, Project Manager and the Degree of Content Expertise Required

III. Discovery: Target Product Profile (TPP)

• What is a TPP?
• Case study
• Templates
• Critical considerations

Exercise: Develop a TPP under Two Different Scenarios (Small Group Work)
Exercise: Discussion Based on Several Templates

IV. Discovery: Project Objectives

• Generating a phase title
• Developing phase objectives
• Prioritizing phase objectives
• Case study

Exercise: Develop a List of Objectives for a Drug Package Selection

V. Discovery: Project Planning

• Keys for successful project planning
• Developing a project plan
• Milestones and contingency planning

Exercise: Develop a Project Plan (Small Group Work)

VI. Discovery: Project Timeline

• Developing a project timeline
  • network analysis
  • critical path
  • case study
  • Gantt chart
  • crashing the project schedule

Exercise: Develop a Critical Path

VII. Discovery: Project Implementation, Monitoring and Control

• Project execution
• Monitoring and control - overview

Review the Course Brochure for Full, Detailed Information.