PTI - international

Agenda: Day Two

Review the Course Brochure for Full, Detailed Information.

VIII. Transitioning a Project from Discovery to Pre-Clinical

IX. Pre-Clinical: Redefining Your Project Team

• Define goals for the preclinical regulatory development phase
• Adjust composition of your project team as appropriate
• Improve efficiency and increase speed

Exercise: Discussion on Core Teams and Core Team Members

X. Pre-Clinical: Updating Your Target Product Profile

• Updating your TPP
• Example of old vs. new TPP
• Highlight key aspects

Exercise: Modify the TPP Developed on Day One Based on New information Obtained

XI. Pre-Clinical: Project Objectives

• Define objectives appropriate to preclinical development:
  • when will studies be initiated?
  • when will studies be completed?
  • when will regulatory filings occur?

XII. Pre-Clinical: Project Planning

• Points to consider when planning
• Determine drug supply needs:
  • single batch?
  • multiple batches?

XIII. Pre-Clinical: Project Timeline

• Scheduling challenges
• Risk management tools

XIV. Pre-Clinical: Project Implementation, Monitoring and Control

• Monitoring tools
• Reporting tools
• Decision-making
• Reviews

Exercise: Case Study on the Three Levels of Monitoring (Small Group Work Using EVA)

XV. Preparing for Regulatory Submission in U.S. and EU

• Investigational New Drug (IND) application and process
• Investigational Medicinal Product Dossier (IMPD) application and process

Review the Course Brochure for Full, Detailed Information.