CMC Regulatory Compliance for Biopharmaceuticals and Biologics

• Understand the critical importance and underlying principles for CMC regulatory compliance of biopharmaceuticals and biologics, and how this leads regulatory agencies to develop different CMC regulatory requirements for these products compared to pharmaceuticals of chemical origin

• Be able to develop a cost-effective, risk-managed CMC regulatory compliance strategy to move a biopharmaceutical or biologic product through each stage of clinical development (from Phase 1 through Phase 3) and into commercialization, and how to maintain CMC regulatory compliance once market approval has been obtained

• Learn how to effectively communicate with regulatory authorities, both verbally and with written submissions, on significant biopharmaceutical and biologic CMC regulatory issues, and how to prepare CTD-formatted Modules 2.3 and 3 for these drug products

Course Description

At each stage of drug development, from Phase 1 through market approval, one basic question needs to be addressed:  ‘What is absolutely necessary, from a CMC regulatory compliance perspective, to be successful in getting our biopharmaceutical/biologic through clinical trials and into the market?’  CMC regulatory compliance deficiencies have resulted in clinical holds and delays in obtaining market approval.  CMC shortfalls in marketed products have also resulted in FDA Warning Letters and product recalls.  Insights and practical suggestions on how to develop and manage a clinical phase-dependent CMC regulatory compliance strategy for biopharmaceuticals and biologics are offered in this course. 

This course also includes a discussion on preparing CMC sections for a market application dossier using the Common Technical Document (CTD) formatted Modules 2.3 and 3 for biopharmaceuticals and biologics. CMC compliance regulations and guidances from the U.S. FDA, EMEA and ICH are discussed.