Drug Development Simulation
(The NDA Game)

Day 1:
General Session
  • Welcome & Introduction
  • Simulation Briefing -- Objectives & Methods
  • Drug Development - Planning Process
  • Team Meetings
  • Learning Objectives
  • Development Strategy
  • Preparing the Drug Development Plan
  • Team Critique
Day 2:
General Session
  • Planning Process Review
  • Team Meetings
  • Completing the Drug Development Plan
  • Trials Selected
  • Plan Organized with Faculty
  • Plan Review with Faculty
  • Team Critique II

 

 

Day 2: 
General Session (cont.)

  • Plan Implementation
  • Registration Packages Finalized
  • Summary Critique
  • Preparation for Registration Package, Review Mtg.
Day 3:  
General Session
  • Registration Package Review Meeting
  • Team Presentations
  • Staff Commentary
  • Learning Critique and Application Planning
  • Summary and Conclusion
  • Program Evaluation