FDA Boot Camp
Tuesday, September 17 to Wednesday, September 18, 2013
Omni Parker House, Boston, MA
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
Attend the pre-conference workshop or post-conference master classes to get the background and/or the in-depth information you need to maximize your learning and networking experience at this event!
Workshop A: Fundamentals of FDA Regulatory Law will address topics to set the stage for the main conference by helping you thoroughly comprehend the structure of the FDA and the essentials of the pre-approval, approval, and post-approval process. Get the background you need to flow seamlessly into the conversations at FDA Boot Camp.
Master Class B: Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics will provide an in-depth overview of biosimilars as well as analyses of bioequivalency and exclusivities and their role in patent and product life cycle management.
Master Class C: Post-Approval Marketing Guidance and Preemption Protocols will address issues that arise post-approval, including advertising, promotion, and off -label promotion and enforcement, as well as preemption fundamentals.
Attend this conference and learn to navigate your way through the regulatory maze that plays such a crucial role to your cases and practice areas. Seats at prior iterations of ACI’s FDA Boot Camp sold out. Don’t delay — register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563, or registering online at www.AmericanConference.com/FDABootCampBoston
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Tue, Sep 17, 2013
Wed, Sep 18, 2013
Omni Parker House