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You can save an extra 10% off the current rate by using code D10-999-JDS19.

Obtain the guidance you need to master the difficult area of FDA regulatory law

For over 15 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. The approval process…pre-approval concerns…product labeling…clinical trials… adverse events reports…patent concerns…and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA. 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.

TO VIEW THE COMPLETE AGENDA, CLICK HERE »

Top Reasons To Attend:

A "Who's Who of the FDA Bar" will give you critical insights on:

•   The structure of FDA and the roles of the three major agency centers: CDER, CBER, and CDHR

•  The application and approval processes for drugs and biologics

•    The complexities of pharmaceutical IP and the regulatory balance between brand name and products

•    The requirements for the advertising, marketing, and promotion of drugs and biologics

•    The importance of cGMPs to the post-approval regulatory process

•     The protocols of adverse events monitoring 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.

Download the conference brochure here »

Complete your training with these interactive workshops:

A | FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws

B | Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Primer on FDA Guidelines and Regulations

C | Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group  

REGISTER NOW and save an extra 10% off the conference by using code D10-999-JDS19.

*Discount is valid for new registration only and it’s not applicable for workshops.