FDA Boot Camp Chicago

Basic Training for Products Liability and Patent Lawyers

Tuesday, September 25, 2007

About

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 from the FDA 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”– 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
  • Advertising and promotional concerns
  • Recalls, product withdrawals, and FDA oversight authority

Contents & Contributors

About

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 from the FDA 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”– 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
  • Advertising and promotional concerns
  • Recalls, product withdrawals, and FDA oversight authority

Contents & Contributors

THE FOOD AND DRUG ADMINISTRATION— AUTHORITY, ORGANIZATION AND OPERATION
Robert B. Nicholas, McDermott Will & Emery LLP

THE NATURE OF THE APPROVAL PROCESS: DRUGS & BIOLOGICS
Erika Lietzan, Covington & Burling LLP

UNDERSTANDING THE CLINICAL TRIAL PROCESS FOR DRUGS AND BIOLOGICS
Wayne H. Matelski, Arent Fox LLP

HATCH-WAXMAN LITIGATION: THE NORVASC® CASE
Aaron F. Barkoff, Ph.D., McDonnell Boehnen Hulbert & Berghoff LLP

PATENT OVERVIEW AND SOME HATCH-WAXMAN FUNDAMENTALS
Natalie M. Derzko, JSD, MS, Covington & Burling LLP

PRESCRIPTION DRUG (INCLUDING BIOLOGICAL PRODUCT) LABELING
Coleen Klasmeier, Sidley Austin LLP

SALES AND MARKETING
Joseph K. Hetrick, Dechert LLP

BIOEQUIVALENCE: WHAT PATENT LAWYERS NEED TO KNOW
Steven H. Sklar, Leydig, Voit & Mayer, Ltd.

FOLLOW-ON BIOLOGICS (BIOSIMILARS)
Donald O. Beers, Arnold & Porter LLP

SPECIAL CONCERNS FOR DIRECT-TO-CONSUMER ADVERTISING
Heather D. Banuelos, Covington & Burling LLP

REGULATION AND DISSEMINATION OF OFF-LABEL INFORMATION
Jeffrey N. Gibbs, Hyman, Phelps & McNamara, P.C.
Presented by: Roger C. Thies, Hyman, Phelps & McNamara, P.C.

ADVERSE EVENTS MONITORING (AKA PHARMACOVIGILANCE)
Joshua M. Glasser, Arnold & Porter LLP
William W. Vodra, Arnold & Porter LLP

CLASSIFICATIONS OF MEDICAL DEVICES AND THE ESSENTIALS OF THE DEVICE PREMARKET REVIEW PROCESS
Pamela J. Furman, Esq., King & Spalding LLP

POST-MARKET REQUIREMENTS AND CONCERNS FOR MEDICAL DEVICES
Laurie A. Clarke, King & Spalding LLP
Pamela J. Furman, Esq., King & Spalding LLP

INTRODUCTION TO FDA REGULATION OF MEDICAL DEVICE LABELING AND ADVERTISING
Laurie A. Clarke, King & Spalding LLP

RECALL GUIDANCE FOR DRUGS, BIOLOGICS AND MEDICAL DEVICES – WHAT YOU NEED TO KNOW
Neil O'Flaherty, Esq., Olsson, Frank and Weeda, P.C.



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0