Kurt Karst is presenting at the FDA Boot CampKurt Karst is speaking on the "Hatch Waxman and BPCIA Overview" on March 11, 2015
WhenSeptember 30, 2015
DoubleTree Suites by Hilton Times Square
New York, New York
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.
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.