FDA Boot Camp — Hooah

As the regulatory landscape for pharmaceutical and medical device companies continues to rapidly change, and as key provisions of health care reform and begin their implementation at federal health agencies, there is a tremendous need to educate stakeholders in the health care industry about these new developments.

Additionally, recent court cases and high-profile trials concerning FDA-regulated products have made it clear that it is essential for attorneys who do not have regulatory practices — but who do deal with FDA-regulated products — to have a familiarity with these concepts.

To address these recent developments, the American Conference Institute will be holding a conference entitled, “FDA Bootcamp,” to assist health care industry professionals in navigating through the complex regulatory framework of federal agencies.

The conference will be held on March 16 – 17, 2011, in Flatotel, New York, and will offer basic training for products liability and patent lawyers. The conference offers continuing legal education credits as well, and will include a distinguished faculty of top FDA regulatory experts — a “Who’s Who of the FDA Bar”— that will share their knowledge and give critical insights on:

• The organization, jurisdiction, functions, and operations of the FDA
• The essentials of the approval process for drugs, biologics, and devices, including:
• NDAs – OTC Approval
• INDs – 510(k) submissions
• BLAs – PMA process
• Clinical trials for drugs and biologics and the clearance process for devices
• The classification of devices and the concept of “risk-based” classification
• The role of the Hatch-Waxman Act in the patenting of 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

Presentations from faculty members such as Arnie Friede, former FDA Associate Chief Counsel, and former Senior Corporate Counsel for Pfizer, Inc., are focused on a number of objectives to help participants:

• Master the basics of the application and approval processes for drugs, biologics, and devices
• Comprehend the structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDHR
• Develop a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices
• Learn how devices are classified, monitored, and regulated
• Appreciate the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products
• Recognize the pivotal role of labeling in the drug and biologics approval process
• See the importance of cGMPs to the post-approval regulatory process
• Navigate the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls

ACI’s FDA Boot Camp was designed to give products or patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA competencies. This conference offers important insight into what happens during the pre-approval, approval, or post-approval periods, which have a significant impact on products liability and patent litigation concerning FDA-regulated products.  The topics covered during the two-day conference include:

• The Basics: Understanding and Working with the FDA — Jurisdiction, Functions, Organization, and Operations
• The Nature of the Approval Process
• Understanding the Clinical Trial Process for Drugs and Biologics
• Patent and IP Overview: Hatch-Waxman, Trade Dress, and More
• Drugs and Biologics: Labeling
• cGMPs: Drugs and Biologics (current Good Manufacturing Practices)
• Follow-On (Comparable or Biosimilar) Biologics
• Bioequivalence: What Patent Lawyers Need to Know
• Challenges, Opportunities, and Current Controversies with the (Non-Patent) Marketing Exclusivities
• Advertising and Promotion
• Off-Label Promotion and Criminal Enforcement
• Preemption Fundamentals
• Adverse Events Monitoring, Pharmacovigilance and Risk Management
• Medical Devices: Classification and the Essentials of the Device Premarket Review Process
• Post-Market Requirements and Concerns for Medical Devices
• Recall Guidance for Drugs, Biologics, and Medical Devices: What You Need To Know

For more information about FDA Bootcamp, faculty, presentations or to register, click here.