Post-Conference Workshops

Workshop D Friday, November 22

8:00 am - 11:00 am
Enhancing Analytical Comparability Strategies to Support Every Stage of Development

Whatever stage of development you’re currently at, progressing to the next phase and adapting your analytical strategy is a key challenge you will need to navigate. This is all in the context of increasing regulatory scrutiny and uncertainty over the analytical and comparability strategies required to satisfy the regulators. Attend this workshop to discuss these topics in more detail:
  • Dissecting the transitions between early and late stages
  • Developing effective bridging studies
  • Dispelling uncertainties around the changes that can be made to processes while maintaining analytical comparability to satisfy regulatory agencies
  • Understanding how analytical methods need to evolve and improve as development reaches later stages
Workshop Leader: David Malliaros, Senior Director, Quality Control, Ultragenyx