Obtain the guidance you need to master the difficult area of FDA regulatory law
For over 15 years, this conference has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Recent news stories and high-profile trials concerning FDA-regulated products have made it clear that it is critical for attorneys who do not have regulatory practices and life sciences executives who deal with FDA regulated products to have a familiarity with these concepts.
ACI’s FDA Boot Camp returns for its 33rd iteration, with the continued intent of providing these individuals with an essential working knowledge of core FDA concepts, and real world examples that will help them to excel in their everyday practices.
Meet Our 2019 Co-Chairs
Rebecca K. Wood
Sidley Austin LLP
Natalie F. Zaidman
Assistant General Counsel, Quality, Sponsor
Oversight and Operations, Clinical
Sidley Austin LLP
Preeminent members of the nation’s Food and Drug bar will drill you in the basics of FDA law and regulation and help you:
COMPREHEND the structure of FDA and the roles of the three major agency centers: CDER, CBER, and CDHR
MASTER the application and approval processes for drugs and biologics
EXAMINE how FDARA and the 21st Century Cures Act are influencing drug approvals through RWE
APPRECIATE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products
GAIN a practical working knowledge of the clinical trials process
RECOGNIZE the pivotal role of labeling in the approval process
DECIPHER requirements for the advertising, marketing, and promotion of drugs and biologics
UNDERSTAND the importance of cGMPs to the post-approval regulatory process
NAVIGATE the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls
Boost your FDA regulatory IQ: Pre-Approval and Post-Approval
In addition, our updated agenda offers advanced guidance sessions focusing on new approval requirements under FDARA and the 21st Century Cures Act, advertising and promotion guidelines for pharmaceuticals and biologics, and a look at the latest initiatives and policies of the FDA.
Don’t miss your opportunity to save with Early Bird rates!
Register now and learn to navigate your way through the regulatory maze that plays such a crucial role to your cases and practice areas.
OUR PRIOR DELEGATES SAY IT BEST:
“This event offers a unique combination of experienced faculty, a comprehensive and up-to-date program, and concise and practical content. For any practitioner in the FDA space who wants to get a powerful learning boost in a compact package, this is a great program to attend.”
– Second co-chair, Christopher M. Mikson Partner at Mayer Brown
“The ACI Boot Camp is the perfect way to learn how to navigate the complexities of the FDA regulatory process that is so critical throughout the life cycle of drugs and biologics.”
– Saira Haider, Patent Attorney, Fresenius Kabi
“Excellent conference with talented speakers who hold a wealth of knowledge.”
– Timothy Benoit-Ledoux, Legal Counsel, Vapotherm