PTI - international

• Identify CMC-related information for Module 1 – US and Europe
• Identify Regional Information in Module 3 – US and Europe

VIII. Streamline the CMC Section for Marketing Applications - Quality Overall Summary

• 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

IX. Utilize Drug Master Files (DMFs)

• Identify types of drug master files
• Analyze DMFs as a tool to effectively communicate CMC information to the agency
• Facilitate a seamless interface between DMF and CMC section of market application
• Comply with current DMF guidance
• Anticipate outcome of EU and US efforts to harmonize DMF systems
• Utilize techniques for tailoring DMFs to CTD format
• Identify best practices for sponsors that reference DMFs

Exercise: Make a List of Benefits and Downsides of DMF Submission

X. Report Post-Approval CMC Changes

• Identify four reporting categories
  • Annual Report (AR)
  • Changes Being Effected (CBE)
  • Changes Being Effected – 30 Days (CBE-30)
  • Prior Approval Supplement (PAS)
• Categorize types of post-approval CMC changes
• Develop strategies to most effectively report post-approval CMC changes to the agency
• Comply with SUPAC and BACPAC requirements
• Use comparability protocols to reduce change reporting category

Exercise: Determine the Appropriate Post-Approval Filing Category and Supporting Chemistry Documentation to Support a Post-Approval Change

XI. Prepare a Comparability Protocol

• Define FDA expectations for comparability protocols
• Assess the impact of the CDER/CBER merge on requirements for comparability protocols
• Determine the benefits of using comparability protocols
• Identify types of CMC changes for which comparability protocols are appropriate and inappropriate
• Describe content of a comparability protocol
• Clarify submission process for comparability protocols

XII. 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
• Assess goals already met and the agency's proposed timeline for advancing the initiative
• Identify the benefits of an integrated CMC review and GMP inspection process

Exercise: Review Recent 483s and Warning Letters to Assess Current Trends
Exercise: Review Outcome of Course Expectations