Pre-market submission is one component of regulatory affairs. This course covers the ongoing obligations that follow a product through its commercial life, including site licensing, change management, deviation
assessment and comparability.
Learning objectives:
- Plan your regulatory strategy beyond first-in-human studies
Understand how to plan for inevitable manufacturing changes while demonstrating
product comparability - Gain a working understanding of Quality by Design principles and tools
Modules:
- Introduction to Adopting a Life-Cycle Approach to Cell & Gene Therapy Manufacturing
- Planning Beyond Clinical Trials
- Key Life-Cycle Concepts
- Planning for the Future
EST. COMPLETION 60 MIN - E-learning format