American Conference Institute’s FDA Boot Camp. Basic training in core regulatory concepts for life sciences lawyers, business executives and policy analysts
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 fi eld to have a clear understanding of the dynamics of the FDA.
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.
Tuesday, March 20 to Wednesday, March 21, 2012
New York, NY
But wait, that’s not all:
ACI is also offering informative and hands-on pre-conference workshop and 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 fl ow 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.
Register today by calling 888-224-2480, faxing your form to 877-927-1563 or online at http://www.americanconference.com/fdabootcampnyc.
PatentBaristas.com is a Media Sponsor of this event. Readers of Patent Baristas are entitled to $200 off the current conference price tier. The discount code you will need for this is: PB 200.