Prepared for distribution at the program of the same name held October 4-5, 2006. "Ord #9046"-- Spine. Includes bibliographical references.
Contents:
United States and European community law related to follow-on biologics / Peter O. Safir. Avoiding pitfalls in technology transfer / Joshua A. Kalkstein -- Counseling on the ethical and legal issues in biomedical research / Clinton D. Hermes, Joanna L. Bergmann -- Basics of FDA approval / David M. Fox -- A global view: U.S. and E.U. approaches to data privacy / Ruth Hill Bro -- An overview of privacy laws impacting pharmaceutical companies / Hilary M. Wandall -- Latest trends in FDA practice / Scott Gottlieb -- Securing exclusivity for your product throughout its life cycle / Gregory J. Glover -- Reforming the current enforcement environment when the legality of pharma marketing practices are in question / I. Scott Bass -- The ABC's of public and private reimbursement / Jorge Lopez, Jr. -- Preemption and the FDA preamble / Robert N. Weiner -- Counterfeit medicines outside the United States: challenges and responses / Jim Hilboldt -- Securing the global supply chain: evolving federal/state law--prescription, drug distribution, counterfeit, pedigree requirements, and the Internet / Matthew B. Van Hook -- Current trends in Hatch-Waxman patent litigation: a system still in flux / Mary W. Bourke, M. Edward Danberg -- Recent trends in patent litigation under the Hatch-Waxman Act / Steven J. Lee -- United States and European community law related to follow-on biologics / Peter O. Safir.
Series:
Intellectual property course handbook series ; no. G-878
This resource is supported by the Institute of Museum and Library Services under the provisions of the Library Services and Technology Act as administered by State Library of Iowa.