Description: ICH Q12 promises to bring benefits to both sponsors and regulators for simpler management of the lifecycle of pharmaceutical products. In this presentation, industry experience with implementing ICH Q12 across three projects (one synthetic molecule initial filing, one biologic molecule initial filing, and one major post-approval change) in the U.S. and Canada will be discussed and evaluated.
Learning Objectives:
Learn the global status of implementation of ICH Q12
Understand the principles, benefits and limitations of adopting ICH Q12
Learn from industry case studies to inform internal decisions for your own projects
