Intensive training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts
NEW YORK CITY, NEW YORK, UNITED STATES, February 13, 2020 /EINPresswire.com/ — This is the original and best training course on the fundamentals of FDA regulation taught by the "who's who" of the FDA bar.
Tailored for life sciences professionals, ACI’s 35th FDA Boot Camp will arm you with the tools you need to have a strong working knowledge of such core FDA regulatory competencies as:
• The application and approval processes for drugs and biologics
• The IP and regulatory interface for brand name and generic products
• The clinical trials process
• The pivotal role of labeling
• The importance of cGMPs to the post-approval regulatory process
• Protocols of adverse events monitoring, signal detection, product withdrawals, and recalls.
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, March 24-25, 2020. 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.
Register now and learn to navigate your way through the regulatory maze that plays such a crucial role to your cases and practice areas.
Register today! Visit www.AmericanConference.com/FDABootCamp
American Conference Institute
email us here
Source: EIN Presswire