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Location: Building 535Phone: (909) 607-9864
Email: diana_bartlett[at symbol]kgi.edu
FDA Law and Regulatory Affairs
This overview of the FDA and regulatory affairs will provide a grounding for professionals in pharmaceutical, biotech, and medical device companies. Topics will include current status of FDA laws; FDA regulatory approval process from IND through submission and review of BLA and post-market approval requirements for a new biologic; FDA regulatory approval process from design input stage through submission and review of the 510(k) documentation and post-market approval requirements.
Format: One day class with group exercises and examples.
Business issues: Development of productive relationships with regulatory bodies takes more than an ability to conduct clinical trials and prepare documents. Strategy, relationships, context, and a variety of other "higher order" thinking is required.
Who should attend? Individual contributors and managers from throughout life science companies with little experience in FDA matters will benefit from this class.
Fee: $500/person, includes materials and lunch.
Instructors:
Date & Location: Future dates to be announced