For over 15 years, this Conference has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Law and Regulation. It’s Time for You to Join Their Ranks.
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.
For this reason, ACI’s FDA Boot Camp returns for its 37th 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.
Conference Co-Chairs
Christopher Mikson
Partner
DLA Piper LLP
(Washington, DC)
Chad Landmon
Partner
Axinn, Veltrop & Harkrider LLP
(Hartford, CT)
LEARN FROM THE MASTERS
A distinguished faculty of top FDA regulatory authorities – a “Who’s Who of the FDA Bar” – will share their knowledge and provide you with critical insights on:
- The organization, jurisdiction, functions, and operations of FDA
- The essentials of the approval process for drugs and biologics
- The role of the Hatch-Waxman Act in the patenting of drugs and biologics
- Clinical trials for drugs and biologics
- Labeling in the drug and biologics approval process
- cGMPs and other manufacturing concerns relative to products liability
- Proactive adverse events monitoring and signal detection
- Recalls, product withdrawals, and FDA oversight authority
Preeminent members of the nation’s Food and Drug bar will drill you in the essentials 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 basics 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 for pharmaceutical products
- RECOGNIZE the pivotal role of labeling in the drugs and biologics approval process
- DECIPHER the requirements for the advertising, marketing, and promotion of drugs and biologics
- UNDERSTAND the importance of cGMPs to the post-approval regulatory process
EARN CLE/ETHICS CREDITS
Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as non-transitional for the purposes of CLE accreditation. Learn More
