1:30pm Perspectives on Regulatory CMC Strategies for Drug-Linkers in Antibody Drug Conjugates
Time: 1:30 pm
day: Day Two CMC Track
Details:
- Perspectives on major regulatory strategies are based on practical, scientific and risk-based from early development to registration.
- Approaches to regulatory starting material designation, controls and control strategies
- Navigating accelerated process validation, regulatory filing documentation, characterization, stability, post-approval changes and post-approval change management plans/comparability protocols
