How to submit variations in Europe MasterClass

Topics

• Differences between change categories (Type IA, IB, II)
• Overview of the European legislation on variations
• Content of a variation dossier
• Impact of a change on the CTD dossier

Who should Attend

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