Who Should Attend
Directors, managers and professionals involved in developing or implementing, and those that need to understand the critical importance of, the Chemistry, Manufacturing & Controls (CMC) regulatory strategy for biopharmaceutical and biologic drug products, including Project Managers, Regulatory Affairs, Manufacturing, Quality Assurance, Quality Control and Process Development personnel.
Learning Objectives
Upon completion of the course, attendees will:
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Understand the important unique CMC regulatory compliance challenges of biopharmaceuticals and biologics, and how this leads regulatory agencies to have different CMC regulatory requirements for biopharmaceuticals and biologics compared to pharmaceuticals of chemical origin
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Develop a cost-effective, risk-managed, clinical phase-dependent CMC regulatory compliance strategy to move these products 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
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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 biopharmaceuticals and biologics
Course Description
With the rapid development and constantly changing Chemistry, Manufacturing & Controls (CMC) landscape of biopharmaceutical and biologic products and their manufacturing process technologies, coupled with ongoing changes in compliance regulations, it is most important for a company to have an effective strategy to achieve CMC compliance. At each stage of drug development, from Phase 1 through market approval, the 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 the clinical trials and onto the market?’
CMC regulatory compliance deficiencies have resulted in clinical holds and delays in market approval. CMC regulatory compliance deficiencies of marketed products have also resulted in FDA Warning Letters and product recalls. Insights and practical suggestions to develop and manage CMC regulatory compliance for biopharmaceuticals and biologics are offered in this course.
This three day course will also present a strategy to obtain a cost-effective, risk-managed, clinical phase-dependent CMC regulatory compliance especially useful for all stages of clinical development and for those biopharmaceutical and biologic products already on the market. This course also includes a discussion on preparing the CMC sections for both clinical trials (IND and IMPD) and a market application dossier (BLA/NDA/MAA) using the ICH Common Technical Document (CTD)-formatted Modules 2.3 and 3 for biopharmaceuticals and biologics.