September 18-19, 2019 | The Bostonian Hotel | Boston, MA

You can save an extra 10% off the current rate by using code D10-999-JDS20.

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 highly publicized trials related to FDA-regulated products show the necessity of having a strong familiarity with these concepts.

Download the conference brochure here »

Top Reasons To Attend:

Distinguished counsel of the Food and Drug bar will drill you in the essential elements of the FDA law and regulation and help you:

· MASTER the core competencies of the application and approval processes for drugs and biologics

· APPRECIATE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products

· GAIN a practical working knowledge of clinical trial process

· RECOGNIZE the pivotal role of labeling

· DECIPHER the requirements for 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


New for 2019 – Special Focus Sessions on:

· The FDA’s Digital Health Initiatives

· Opioid and Other Controlled Substances Classifications

· The Impact of FDARA on Drug Approvals Complete your training with these interactive workshops:

A | FDA 101 (with Ethics Bonus): A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws

B | Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Guide to 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-JDS20.