American Conference Institute's 22nd
FDA Boot Camp
Basic training in core regulatory concepts for life sciences lawyers, business executives and policy analysts
Wednesday, March 12 to Thursday, March 13, 2014
DoubleTree Suites Times Square, New York, NY
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.
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:
“I found the information was quite helpful and covered much material.” Kelli Davis, Senior Paralegal, Novo Nordisk, Inc. (2013 delegate) “Excellent conference! I got exactly what I was hoping to get.” (2013 delegate)Our prior delegates say it best:
Past iterations of the Boot Camp sold out; register now to ensure your place at this unique and important event. Call 1-888-224-2480, fax your registration form to 1-877-927-1563 or log onto www.americanconference.com/fdabootcampnyc.
For information on sponsoring or exhibiting at this event, contact Wendy Tyler at firstname.lastname@example.org.
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Wed, Mar 12, 2014
Thu, Mar 13, 2014
DoubleTree Suites Times Square
New York, NY