• Outline of the Drug Development Process
• How does Project Management fit?
• Best Practices in Project Management applied to the Drug Development Process and Current Trends
• Project Core Teams, Project Managers and Leaders
• Leadership Skills

Target Product Profiles and the Clinical Trial Process 

• Review the Target Product Profile
• The Clinical Trial Process

Updating the Target Product Profile and the Project Objectives

• Target Product Profile versus Labels
• The value of Phase Gate related objectives
• How to truly measure success

Managing the Project: Timelines and Budgets 

• Generally accepted metrics
• Budgets, Grants, Contracts (selecting the best option)
• Creating a Timeline and Critical Path
• Impact of Outsourcing Decisions

• Best Practices
• Recent Trends

Life Cycle Management 

• Does the Commercialization phase requires new project plans, project managers, project leaders, metrics &?
• Redefining your project teams
• Ensuring a smooth transition

Outsourcing and Drug Delivery Systems

• Outsourcing Trends
• Clinical Supplies Outsourcing
• Developing and Maintaining a High Performance Partnership
• Benefits and Strategies around Drug Delivery Systems

Partnering with a CRO

• Best Practices
• Lessons Learned from several true stories

Summing it all up


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