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Be a Better Life Sciences Products Litigator or Patent Attorney...
Develop Greater Securities and Investment Expertise in Your Field…
Learn about the FDA Approval Process and the Ins and Outs of Post-Approval Challenges
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.
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. Today, this lack of knowledge has become a great handicap for these lawyers and executives as products liability and patent litigation concerning these products often hinges on what happened during the pre-approval, approval, or post-approval periods. Every phase of litigation - from discovery to trial - concerning FDA-regulated products is in some way affected by occurrences during these critical phases.
ACI's publication from the
FDA Boot Camp is a selection of presentations from top industry experts and 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 insights on:
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 FOOD AND DRUG ADMINISTRATION-AUTHORITY, ORGANIZATION AND OPERATION
Robert B. Nicholas, McDermott Will & Emery LLP
NEW CONSIDERATIONS IN DRUG AND BIOLOGICALS PRODUCT DEVELOPMENT FOR THE NEW MILLENNIUM: CMS, PBM'S, P&T COMMITTEES AND MORE
Edward John Allera, Buchanan Ingersoll
THE APPROVAL PROCESS: DRUGS & BIOLOGICS
Erika King Lietzan, Covington & Burling
UNDERSTANDING THE CLINICAL TRIAL PROCESS FOR DRUGS AND BIOLOGICS
Wayne H. Matelski, Arent Fox LLP
PATENT AND IP OVERVIEW FOR DRUGS AND BIOLOGICS: HATCH-WAXMAN, TRADE DRESS, AND MORE
(HYPOTHETICAL LIFECYCLE OF A DRUG MOLECULE)
William D. Hare, Ranbaxy Pharmaceuticals Inc.
THE GAME OF THE NAME: ISSUES IN THE IDENTIFICATION OF PHARMACEUTICALS
Jack R. Bierig, Sidley Austin LLP
DRUGS AND BIOLOGICS LABELING
Coleen Klasmeier, Sidley Austin LLP
NON-PATENT EXCLUSIVITY AND 505(B)(2) APPLICATIONS
Robert F. Green, Leydig, Voit & Mayer, Ltd.
DRUG ADVERTISING AND PROMOTION
Gary C. Messplay, Hunton & Williams LLP.
BIOEQUIVALENCE: WHAT PATENT LAWYERS NEED TO KNOW
Steven H. Sklar, Partner, Leydig, Voit & Mayer, Ltd.
FOLLOW-ON BIOLOGICS
Donald O. Beers, Arnold & Porter LLP
SPECIAL CONCERNS FOR DTC ADVERTISING
Karen A. Weaver, Epstein Becker & Green, P.C.
REGULATION AND DISSEMINATION OF OFF-LABEL INFORMATION
Jeffrey N. Gibbs, Phelps & McNamara, P.C.
Presented by: Roger Theis, Hyman, Phelps & McNamara, P.C.
ADVERSE EVENTS MONITORING (AKA PHARMACOVIGILANCE)
William Vodra, Arnold & Porter LLP
CLASSIFICATION OF MEDICAL DEVICES AND THE ESSENTIALSOF THE DEVICE APPROVAL PROCESS
Pamela J. Furman, Olsson, Frank and Weeda, P.C.
510(K) PREMARKET NOTIFICATIONS
Laurie A. Clarke, King & Spalding LLP
PMA APPLICATIONS AND POSTAPPROVAL REQUIREMENTS
Gregory H. Levine, Arnold & Porter LLP
MARKETING AND PROMOTIONAL CONSIDERATIONS FOR DEVICES
Frederick H. Branding, McGuire Woods LLP
RECALL GUIDANCE FOR DRUGS, BIOLOGICS AND MEDICAL DEVICES: WHAT YOU NEED TO KNOW
Neil O'Flaherty, Olsson, Frank and Weeda, P.C.
Publication Details