American Conference Institute's

FDA Boot Camp

Basic training in core regulatory concepts for life sciences lawyers, business executives and policy analysts

Tuesday, March 19 to Wednesday, March 20, 2013
Doubletree Suites Times Square, New York, NY
Get the ultimate roadmap to the complicated landscape of FDA regulatory law

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. 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 changing business dynamics of the life sciences industry have also made it critical for business executives, policy analysts and securities experts who work in this field to have a clear understanding of the dynamics of the FDA.

Law-suits • Business Development and Investment Strategies
Compliance Protocols • Policy Matters • Pricing and Reimbursement Decisions Patent and Product Life Cycle Management

Litigation as well as numerous other legal, business, and policy decisions concerning
FDA-regulated products often hinge on what happened during the pre-approval, approval, or post-approval periods.

Many products liability lawyers, patent counsel, business and investment experts, medical and regulatory affairs professionals, and those involved in pricing and reimbursement — 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. Whether you are a products liability or patent litigator, in-house counsel, in-house business development or federal affairs professional, FDA Boot Camp will provide you the insights you need.

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, industry in-house counsel, 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