Key Considerations in Preparing for Commercial Approval and Launch

A panel of cross-functional subject matter experts (SMEs) will share their perspectives and “lessons learned’ on various elements of commercial readiness. Topics will cover best practices and recommendations around regulatory considerations, process characterization, PPQ, PLI readiness, clinical readiness, supply chain, and other launch-related topics. Audience will be encouraged to participate in the Q&A session, as well as complete a high-level readiness checklist which can be submitted to the panel SMEs for post-conference feedback.