Biopharmaceuticals (includes Biologics)
Mark Louis Slisz:
Dealing with Module 3 regulatory updates and changes to applications that can be decades old are both challenging and difficult. This session will discuss the strategy to using a risk-based approach to handle regulatory application revisions, especially considering regulatory guidance, regulatory trends, and industry standard changes in the last 25 years. Included will be less is more (i.e., ELA and PLA to a BLA) and more is better (e.g., critical process controls, additional USP testing, etc.). The importance of due diligence when reviewing the application prior to receiving through licensure, transfer, or purchase will be considered, focusing on the initial application, which may have been approved decades ago, along with the supplements throughout the product life-cycle. How do you handle documentation that is unavailable, is somewhere in a warehouse (i.e., paper copies), buried in annual reports and never included in the Quality section of the application, or was beyond the level of detail required but is now considered a commitment, and analytical tests either in-process or release that have been added that do not address the quality of the drug substance/drug product? Once the application is in your control, what do you do now – how do you assure that the manufacture of the drug substance and drug product meet all regulatory commitments that have been filed with all Competent Authorities? Various suggestions and options will be discussed to bring the clinical trial or commercial application up-to-date to meet current standards.