The Center for Professional Innovation & Education, Costa Mesa, CA
12/1/08
Who Should Attend
Managers and professionals involved in developing or implementing the Chemistry, Manufacturing & Controls (CMC) regulatory strategy for biopharmaceutical and biologic drug products will benefit from this course. Project Managers, Regulatory Affairs, Manufacturing, Quality Assurance, Quality Control and Process Development personnel and those that need to understand the critical importance of CMC compliance will find the course particularly useful.
Learning Objectives
Upon completion of the course, attendees will:
- Understand the importance and underlying principles for CMC regulatory compliance 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
- Learn how to develop a cost-effective, risk-managed CMC regulatory compliance strategy to move 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
- Be able to effectively communicate with regulatory authorities, both verbally and with written submissions, on significant biopharmaceutical and biologic CMC regulatory issues. Additionally, attendees will learn 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 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 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 a market application dossier using the Common Technical Document (CTD)-formatted Modules 2.3 and 3 for biopharmaceuticals and biologics.
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