GET THE ULTIMATE ROADMAP TO NAVIGATE THE COMPLEX LANDSCAPE OF FDA REGULATORY LAWACI’s FDA Boot Camp is designed to provide professionals working in conjunction with pharmaceuticals, biologics, and combination products – such as patent and products litigators, in-house counsel, regulatory affairs specialists, business executives, and investors – a strong working knowledge of core FDA competencies. In addition to providing a “basic training,” our BRAND NEW 2018 AGENDA offers “advanced training” sessions covering the “ins and outs” of applying this knowledge to real-life situations. Highlights from this year’s program include an up-to-the minute “Ripped from the Headlines” section covering recent hot issues such as the 21st Century Cures Act, FDARA, recent actions of the new FDA Commissioner, and their impact on FDA practice.
- LEARN tips and strategies for communicating with FDA – NEW FOR THIS YEAR!
- MASTER the basics of the application and approval processes for drugs and biologics
- COMPREHEND the structure of FDA
- DEVELOP a practical working knowledge of clinical trials for drugs and biologics
- APPRECIATE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products
- RECOGNIZE the pivotal role of labeling in drugs and biologics
- SEE the importance of cGMPs to the post-approval regulatory process
- NAVIGATE the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls
Our prior delegates say it best:
“Comprehensive overviews; invaluable resource; anticipate referencing slides often; good information. This was an excellent CLE. Highly informative! It was great to attend an event that covered a broad spectrum of legal issues for our industry. It will help me better understand what my colleagues are working on. A wealth of information presented by knowledgeable individuals, providing numerous takeaways that will be put to practical use. Nice balance between general overview and a couple of specifics without getting bogged down in details.”