PTI - international

• Compare Europe, Japan and US outlook on the CTD
• Identify CMC-related information for Module 1 – US and Europe
• Identify regional information in Module 3 – US and Europe
• Examine the quality overall summary (QOS)
• Determine best strategies to implement QOS
• Determine who is responsible for writing the QOS
• Avoid information overlap from Body of Data (Module 3) in the QOS

VI. Comply with International Registration Requirements

• Identify major hurdles to international registration
• Identify unique CMC requirements in ICH and the rest of world (ROW) countries:
  • Japan (ICH region)
  • EU (ICH region)
  • Australia/New Zealand
  • PACRim
• Assess impact of CTD on international marketing application process
• Prepare submissions for ICH regions
• Implement document modularization techniques for CTD filing to multiple agencies

VII. Demonstrate Biopharmaceutical Product Comparability

• Define FDA expectations for comparability protocols
• Comply with ICH Q5E
• Determine the benefits of using CPs
• Identify types of CMC changes for which CPs are appropriate and inappropriate
• Develop an effective comparability protocol
• Clarify submission process for comparability protocols

Case Study: Biologic Product Comparability Protocol

VIII. Understand the FDA's Risk-Based Initiative

• Outline objectives of FDA's GMP Risk-Based Approach
• Determine how the FDA's risk-based initiative will affect CMC submission requirements
• Identify the benefits of an integrated CMC review and GMP inspection process

Exercise: Review Recent Warning Letters to Assess Current Trends

IX. Report Post-Approval CMC Changes

• Identify four reporting categories
• Categorize types of post-approval CMC changes
• Develop strategies to most effectively report post-approval CMC changes to the agency

Exercise: Create a Sample Manufacturing Change and Classify the Change