FDA Boot Camp

March 24, 2010 - March 25, 2010
New York, NY

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 which are governed by FDA law and regulation, including the FDA Amendments Act of 2007 (FDAAA). 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.

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

Additionally, the regulatory complexities that permeate the industry, have also made it critical for business executives and securities experts in the life sciences arena to have a rudimentary knowledge of these matters as well.

An understanding of the FDA regulatory schematic is tantamount to VC and investment success in the drug and device sectors.

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 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 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 - 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

Who Should Attend

Attorneys for the pharmaceutical, biotech, and medical device industries whose practices focus on:

  • Products liability litigation
  • Patent litigation
  • Patent prosecution

In-house counsel for the pharmaceutical, biotech, and medical device industries with responsibility for:

  • Litigation
  • Patents and IP

Securities Attorneys with practices in pharmaceuticals, biotech and device

Investment Bankers and Venture Capitalists with practices in pharmaceuticals, biotech and device

Meet the Speakers

Daniel A. Kracov
Arnold & Porter
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