CMO/CDMO Relationships, Management, and Quality | As more organizations rely on CMO/CDMOs to meet supply demands, managing multiple sponsor requirements becomes challenging. As a sponsor, ensuring your requirements are met are critical. The track will specifically focus on the process of application and revision of such following significant compliance findings (eg Data Integrity) at the CMO/CDMO. What are some of the expectations if the applicant decides to withdraw the facilities (CMO) specifically under compliance action for the pending applications? What new data would be needed to support the application with the addition of a new site? We will discuss the challenges of a sponsor working with multiple CMOs during a pandemic and provide strategies to ensure adequate controls, oversight and consistency.

Regulatory and Industry Panel | Maintaining Full Transparency with Regulatory Agencies