For over fifteen years, ACI’s FDA Boot Camp has been the “go-to” program for pharmaceutical professionals to obtain a deep understanding of the fundamentals of FDA law and regulation. Don’t miss your opportunity to join their ranks.
Having a strong grasp of vital FDA regulatory protocols to bring a pharmaceutical or biological product to market, from the pre-approval to post-approval processes remains essential for attorneys, regulatory professionals and executives within the life sciences industry. Recent agency actions and highly publicized trials related to FDA regulated products only furthers the need to have an in-depth understanding of such fundamental FDA concepts as NDAs, BLAs, product labeling, clinical trials, adverse events reports, patent concerns, and exclusivity.
ACI’s FDA Boot Camp returns to New York for its 35th edition with the intention of providing life sciences legal professionals and executives with a working knowledge of essential FDA concepts, and real-world examples that will guide them in their everyday practice.
The complete agenda and faculty list will be available shortly.
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New for the 2020 New York Program
- The FDA’s Digital Health Initiatives
- Opioid and Other Controlled Substances Classifications
Distinguished members of the FDA bar will drill you in the essential elements of FDA law and regulation and help you:
- COMPREHEND the structure of FDA and the roles of the CDER, CBER,and CDHR
- MASTER the application and approval processes for drugs and biologics
- EXAMINE the effects of real-world evidence on the drug approval process
- EXPLORE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products
- OBTAIN a practical working knowledge of the clinical trials process
- ANALYZE the pivotal role of labeling
- DIFFERENTIATE the requirements for the advertising, marketing, and promotion of drugs and biologics
- GRASP the importance of cGMPs to the post-approval regulatory process
- NAVIGATE the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls
To complete your regulatory training, and to boost your European pharmaceutical regulatory IQ, join us at ACI’s European Pharmaceutical Regulatory Law Boot Camp taking place on June 25, 2020.
ACI’s Global Series of Life Sciences conferences bring together key sector stakeholders from around the globe to explore the most important trends impacting the many industries including pharmaceutical, biotechnology, medical device/diagnostics, and FDA-regulated consumer products. Our events cover every facet of legal and business relevance as well as controversy. Learn More