FDA BOOT CAMP

Tuesday, March 31, 2009

About

This 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, including the nuances of the one of the most comprehensive revisions of FDA law in decades, the FDA Amendments Act of 2007 (FDAAA).

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.

However, recent court cases and high-profile trials concerning FDA-regulated products send a clear signal that attorneys who do not have regulatory practices – but who do deal with FDA-regulated products – must understand these concepts. The same demands fall on 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.

Designed specifically to provide you with a clear understanding of this complicated area, 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 biological products approval process
  • cGMPs and other manufacturing concerns relative to products liability
  • Proactive adverse events monitoring
  • Recalls, product withdrawals, and FDA oversight authority

Contents & Contributors

About

This 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, including the nuances of the one of the most comprehensive revisions of FDA law in decades, the FDA Amendments Act of 2007 (FDAAA).

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.

However, recent court cases and high-profile trials concerning FDA-regulated products send a clear signal that attorneys who do not have regulatory practices – but who do deal with FDA-regulated products – must understand these concepts. The same demands fall on 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.

Designed specifically to provide you with a clear understanding of this complicated area, 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 biological products approval process
  • cGMPs and other manufacturing concerns relative to products liability
  • Proactive adverse events monitoring
  • Recalls, product withdrawals, and FDA oversight authority

Contents & Contributors

The Basics: Understanding and Working with the FDA and the Obama Administration – Jurisdiction, Functions, Organizations, & Operations
Robert B. Nicholas, Partner, McDermott Will & Emery LLP (Washington, D.C.)

The Nature of the Approval Process
Erika Lietzan, Partner, Covington & Burling LLP (Washington, D.C.)

Essential Requirements of the Clinical Trials Processes

Scott M. Lassman, Partner, WilmerHale (Washington, D.C.)

Patent & IP Spotlight: Hatch-Waxman, the Patenting Process, and More
Bruce M. Wexler, Partner, Paul Hastings Janofsky & Walker LLP (New York, NY)

Drugs, Biological, and Medical Device Products: Labeling
Sheldon T. Bradshaw, Partner, Hunton & Williams LLP (Washington, D.C.)

Current Good Manufacturing Practices (cGMPs) and Quality System Regulation (QSR)
Robert Dormer, Director, Hyman, Phelps, & McNamara P.C. (Washington, D.C.)

Non-Patent Exclusivity
Aaron F. Barkoff, Ph.D., Partner, McDonnell Boehnen Hulbert & Berghoff LLP, (Chicago, IL)

Bioequivalence: What Patent Lawyers Need to Know

Chad A. Landmon, Partner, Axinn Veltrop & Harkrider LLP, (Hartford, CT and Washington, D.C.)

Follow-On (Comparable or Biosimilar) Biologics
Donald R. Ware, Partner, Foley Hoag, LLP (Boston, MA)

Advertising and Promotion

Karen Weaver, Partner, Baker Hostetler (Los Angeles, CA)

Regulation and Dissemination of Off-Label Information
Alan G. Minsk, Partner, Arnall Golden Gregory LLP (Atlanta, GA)

Preemption Fundamentals
Mark Herrmann, Partner, Jones Day, (Chicago, IL)



DOCUMENT TYPES: PPT PPTX PRESENTATIONS AVAILABLE: 15

7:30
Registration and Continental Breakfast
8:45
Co-Chairs' Opening Remarks
Mr. Rob B Nicholas
Partner
McDermott Will & Emery LLP
Mr. Scott Danzis
Partner
Covington & Burling LLP
9:00
The Basics: Understanding and Working with the FDA and the Obama Administration - Jurisdiction‚ Functions‚ Organizations‚ & Operations
Mr. Rob B Nicholas
Partner
McDermott Will & Emery LLP
1 file
THE FOOD AND DRUG ADMINISTRATION: Authority, Organization and Operation A Practical Guide
845.5 KB 69 pages Presentation
PPT - THE FOOD AND DRUG ADMINISTRATION:Authority, Organization and Operation A Practical Guide
10:00
Morning Coffee Break
10:15
The Nature of the Approval Process
Ms. Erika Lietzan
Partner
Covington & Burling LLP
1 file
The Nature of the Approval Process: Rx Drugs, Biological Products & Medical Devices
215.5 KB 20 pages Presentation
PPT - The Nature of the Approval Process: Rx Drugs, Biological Products & Medical Devices
11:30
Essential Requirements of the Clinical Trials Processes
Mr. Scott M. Lassman
Partner
Kleinfeld‚ Kaplan and Becker‚ LLP
1 file
Lassman-Promoting_Transparency_in_Clinical_Trials
2.2 MB 17 pages Presentation
PPT - Lassman-Promoting_Transparency_in_Clinical_Trials
12:30
Networking Luncheon for Delegates and Speakers
13:45
Patent & IP Spotlight: Hatch-Waxman‚ the Patenting Process‚ and More
Bruce M. Wexler
Partner
Paul, Hastings, Janofsky & Walker LLP
1 file
Patent & IP Spotlight: Hatch-Waxman, the Patenting Process, and More
582.5 KB 43 pages Presentation
PPT - Patent & IP Spotlight:  Hatch-Waxman, the Patenting Process, and More
14:45
Afternoon Refreshment Break
15:00
Drugs‚ Biological‚ and Medical Device Products: Labeling
Mr. Sheldon T. Bradshaw
Partner
Hunton & Williams LLP
1 file
Drugs and Biological Products: Labeling
15.8 MB 65 pages Presentation
PPT - Drugs and Biological Products:  Labeling
16:00
Current Good Manufacturing Practices (cGMPs) and Quality System Regulation (QSR)
- Mr. Robert A. Dormer
Director
Hyman‚ Phelps & McNamara‚ P.C.
1 file
ACI’s FDA Boot Camp: Basic Training for Products Liability and Patent Lawyers
534 KB 49 pages Presentation
PPT - ACI’s FDA Boot Camp: Basic Training for Products Liability and Patent Lawyers
17:00
Conference Adjourns for Day
7:30
Continental Breakfast
8:00
Chairs' Opening Remarks
Arnold I. Friede, Esq.
Principal
Arnold I. Friede and Associates
Michael S. Labson
Partner
Covington & Burling LLP
8:10
Non-Patent Exclusivity
Mr. Aaron F. Barkoff
Partner
McAndrews, Held & Malloy, Ltd.
1 file
Non-Patent Exclusivity
213 KB 20 pages Presentation
PPT - Non-Patent Exclusivity
8:10
Advertising and Promotion
Karen Weaver
Vice President & Associate General Counsel, Regulatory
CareFusion Corporation
1 file
Advertising and Promotion
363 KB 61 pages Presentation
PPT - Advertising and Promotion
9:10 Bioequivalence: What Patent lawyers Need to Know
Chad A. Landmon
Partner
Axinn Veltrop & Harkrider LLP
1 file
Bioequivalence - What Patent Lawyers Need To Know
1.5 MB 33 pages Presentation
PPT - Bioequivalence -  What Patent Lawyers Need To Know
9:20 Regulation and Dissemination of Off-Label information
Mr. - Alan G Minsk
Partner
Arnall Golden Gregory LLP
1 file
MinskA
442.5 KB 36 pages Presentation
PPT - MinskA
10:10 Morning Coffee Break
10:20 Follow-On (Comparable or Biosimilar) Biologics
Mr. Donald R. Ware
Partner
Foley Hoag LLP
1 file
Follow-On Biologics: The Evolution of an Approval Pathway
3.2 MB 41 pages Presentation
PPT - Follow-On Biologics:The Evolution of an Approval Pathway
10:20 Preemption Fundamentals
Mr. Mark Herrmann
Partner
Jones Day
1 file
Drug and Device Law
87.5 KB 3 pages White Paper
PPT - Drug and Device Law
11:20
Import/Export Guidelines & Emerging International Regulatory Concerns
Ms. Jill B. Deal
Partner
Venable LLP
1 file
INTERNATIONAL ISSUES
1.4 MB 45 pages Presentation
PPT - INTERNATIONAL ISSUES
12:00
Networking Luncheon for Delegates and Speakers
13:15
Adverse Events Monitoring‚ Pharmacovigilance‚ and Risk Management
Ms. Vernessa T. Pollard
Counsel
Arnold & Porter
1 file
Understanding Adverse Event Monitoring, Pharmacovigilance and Risk Management
305.2 KB 41 pages Presentation
PPTX - Understanding Adverse Event Monitoring, Pharmacovigilance and Risk Management
14:00
Recalls and Withdrawals
Mr. Neil F. O'Flaherty
Partner
Olsson Frank Weeda Terman Bode Matz PC
1 file
Recall Guidance For Drugs, Biologics And Medical Devices
211 KB 51 pages Presentation
PPT - Recall Guidance For Drugs, Biologics And Medical Devices
14:45
Conference Concludes