Llorente Bonaga

Company: Merck & Co

Job title: Senior Director - Regulatory Affairs & Chemistry Manufacturing Control

Seminars:

2:30pm Perspectives on Regulatory CMC Strategies for Drug-Linkers in Antibody Drug Conjugates 2:30 pm

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 protocolsRead more

day: Day Two CMC Track