FDA Boot Camp

Basic Training for Products Liability and Patent Lawyers

Monday, March 26, 2007

About

Be a Better Life Sciences Products Litigator or Patent Attorney... Develop Greater Securities and Investment Expertise in Your Field…

The approval process…pre-approval concerns…product labeling… clinical trials…adverse events reports… patent concerns… exclusivity. All are critical aspects in the commercialization process for drugs, biologics, and devices that are governed by FDA law and regulation. 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. The same can be said of securities experts and business executives in the life sciences arena.

Products liability and patent litigation concerning these products often hinges on what happened during the pre-approval, approval, or post-approval periods.

However, many products liability lawyers, patent counsel, and business and investment experts —
despite their tenure in working with FDA-regulated products — are not well-versed in the essentials of the approval process and the regulatory hurdles of the post-approval period.

Boost your FDA regulatory IQ.
Learn about the FDA approval process and the ins and outs of post-approval challenges.

ACI’s publication form theFDA Boot Camp has been 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 regulatory competencies.

A distinguished faculty of top FDA regulatory experts — a “Who’s Who of the FDA Bar” — will share their knowledge and give you 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
    • INDs
    • BLAs
    • OTC approval
    • 510 K submissions
    • 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

Contents & Contributors

About

Be a Better Life Sciences Products Litigator or Patent Attorney... Develop Greater Securities and Investment Expertise in Your Field…

The approval process…pre-approval concerns…product labeling… clinical trials…adverse events reports… patent concerns… exclusivity. All are critical aspects in the commercialization process for drugs, biologics, and devices that are governed by FDA law and regulation. 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. The same can be said of securities experts and business executives in the life sciences arena.

Products liability and patent litigation concerning these products often hinges on what happened during the pre-approval, approval, or post-approval periods.

However, many products liability lawyers, patent counsel, and business and investment experts —
despite their tenure in working with FDA-regulated products — are not well-versed in the essentials of the approval process and the regulatory hurdles of the post-approval period.

Boost your FDA regulatory IQ.
Learn about the FDA approval process and the ins and outs of post-approval challenges.

ACI’s publication form theFDA Boot Camp has been 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 regulatory competencies.

A distinguished faculty of top FDA regulatory experts — a “Who’s Who of the FDA Bar” — will share their knowledge and give you 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
    • INDs
    • BLAs
    • OTC approval
    • 510 K submissions
    • 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

Contents & Contributors

The Approval Process: Drugs & Biologics
Erika King Lietzan, Covington & Burling LLP (Washington, DC)

Understanding the Clinical Trial Process for Drugs and Biologics
Wayne H. Matelski, Arent Fox LLP (Washington, DC)

Pharmaceutical Trademarks
Dickerson M. Downing, Crowell & Moring LLP (New York, NY)
Julia K. Smith, Crowell & Moring LLP (New York, NY)

Patent and IP Overview ror Drugs and Biologics: Hatch-Waxman, Trade Dress, and More
William D. Hare, Ranbaxy Pharmaceuticals Inc. (Princeton, NJ)
Carmen Shepard, Buc & Beardsley (Washington, DC)

FDA/FTC Regulation of Drug Advertising and Promotion
Philip Katz, Hogan & Hartson LLP (Washington, DC)

Direct-To-Consumer Advertising
Daniel R. Dwyer, Kleinfeld, Kaplan & Becker, LLP (Washington, DC)

Follow-On Biologics
Donald O. Beers, Arnold & Porter LLP (Washington, DC)

Regulation and Dissemination of Off-Label Information
Jeffrey N. Gibbs, Hyman Phelps & McNamara (Washington, DC)

Adverse Events Monitoring
William W. Vodra, Arnold & Porter LLP (Washington, DC)

Classification of Medical Devices and the Essentials of the Device Premarket Review Process
Pamela J. Furman, King & Spalding LLP (Washington, DC)

Post-Market Requirements and Concerns for Medical Devices
Mark Heller, Goodwin Procter LLP (Washington, DC)

FDA Boot Camp: Introduction to FDA Regulation of Medical Device Labeling and Advertising
Laurie A. Clarke, King & Spalding LLP (Washington, DC)



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