Yue Huang

Company: Daiichi Sankyo

Job title: Ex Regulatory Affairs, Chemistry, Manufacturing & Controls Manager

Seminars:

12:00pm Navigating Regulatory Challenges to Address ADC CMC Change Hurdles for BLA/NDA Approval 12:00 pm

Gaining insights into regulatory frameworks and strategies for submission timelines to support efficient manufacturing during the clinical phase and preparation for BLA/NDA submission Setting comparability study acceptance criteria for site transfer and scale-up during clinical phase Leveraging CMC lessons learned from global case studies to adapt to regulatory compliance for setting product release specifications and…Read more

day: Day One CMC Track