PTI - international

I. Examine Current CMC Requirements

• Introduction and course objectives
• Provide background on the CTD
• Outline CMC regulatory framework
• Identify the most recently issued FDA and ICH CMC guidances

Exercise: Review Participants' Backgrounds and Identify Common Goals for this Course

II. Determine Strategies for the CMC section of an IND and IND Amendments

• Identify level of CMC data necessary for drug substance
• Identify level of CMC data necessary for drug product
• Define current FDA expectations

Discussion: Data Inclusion for IND and IND Amendments

III. Plan for FDA/Sponsor Meetings

• Identify key CMC meetings
• Define purpose and focus of each meeting:
  • Pre-Investigational New Drug Application (Pre-IND)
  • End of Phase Two (EOPII)
  • Pre-New Drug Application (Pre-NDA)
• Identify specific CMC issues relevant to each FDA/sponsor meeting
• Outline procedures for submission of written meeting requests and information packages
• Enhance communication with FDA by conducting "CMC-specific" meetings

Exercise: Interactive Discussion of Real-World Experiences

IV. Determine the International Conference on Harmonization's Impact on CMC

• Outline the ICH history and process
• Comply with ICH quality guidances
• Review the CTD quality guidance
• Compare Europe, Japan and US outlook on the CTD
• Identify unique CMC requirements in ICH and the rest of world (ROW) countries:
  • Japan (ICH region)
  • China
  • EU (ICH region)
  • Australia
  • PACRim

Discussion: Benefits of ICH and Impact on Regulatory Submissions

V. Streamline the CMC Section for Marketing Applications - Drug Substance

• Examine US regulatory requirements for Drug Substance
• Identify major differences for European requirements for CTD content – Drug Substance

Exercise: Analyze Drug Substance Section Requirements and Identify Major Pitfalls

VI. Streamline the CMC Section for Marketing Applications – Drug Product

• Examine US regulatory requirements for Drug Product
• Identify major differences for European requirements for CTD content – Drug Product
• Apply techniques for implementing the Pharmaceutical Development Report (section 3.2.P.2)
• Identify location(s) for information regarding Validation of Sterilization Process

Exercise: Analyze Drug Product Section Requirements and Identify Major Pitfalls