Advanced CMC Masterclass - EU edition

Topics

• Challenges for post-approval CMC changes
• The Different Levels of Requirements in CMC during Development and Post-Approval Phase
• How to justify the choice of Registered Starting Materials (RSM)
• What are the essential requirements for a drug substance
• The pharmaceutical development section of the CTD dossier

Who should Attend

• Regulatory Affairs CMC authors or reviewers
• Quality assurance specialists
• Project managers with CMC responsibilities
• Analytical and stability laboratory (R&D through GMP)
• Product scientists and test method
• Chemistry, Manufacturing & Controls (CMC) regulatory