American Conference Institutes 26th
FDA Boot Camp
Basic training in core regulatory concepts for life sciences lawyers, business executives, scientists, and policy analysts
Wednesday, September 30 to Thursday, October 01, 2015
TBD, Boston, MA
Now in its 26th iteration, FDA Boot Camp is the premier event that will provide you with the ultimate roadmap to the complicated landscape of FDA regulatory law
ACI’s FDA Boot Camp has been designed by leading regulatory attorneys to give professionals that work in conjunction with the pharmaceutical, biologics, and medical devices industries—such as 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:
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.
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Wed, Sep 30, 2015
Thu, Oct 01, 2015