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Seminars, Lectures, & Publications
Center for Professional Innovation and Education (CfPIE), Industry Course
Teach industry course on FDA and other advertising and promotion regulatory and legal standards, their application to the advertising and promotion of drug and medical device products, detailed analysis of advertisements and FDA warning letters and enforcement, including regulations and policies of the FDA, FTC, DEA, PHS, Office of the Inspector General (OIG), state Boards of Pharmacy, attorneys general and prosecutors, professional guidelines of relevant organizations including ACCME, ACP, PhRMA, ADVAMED, AMA. Topics include Continuing Medical Education, Advertising of Compounding Products, Off-Label Promotion, Gifts to Physicians, Direct-to-Consumer Advertising, Risk Information. Discuss advertisements and case studies, including notable enforcement actions by the FDA and FTC.
Publications
Chapter, “FDA's Antibiotic Regulatory Scheme,” in The Pharmaceutical Regulatory Process, Marcel Dekker, 2004
Article, “Pharmaceutical Importation: FDA’s Personal Use Exemption,” Pharmaceutical Forrmulation & Quality, April/May 2001
Chapter, “The Legal Basis for Validation,” in Validation of Bulk Pharmaceutical Chemicals, Interpharm Publishing, Chicago, Ill. (2nd ed. 2001; 1997)
Article, “Guidance Brings Some Closure to a Contentious Topic—FDA’s Policy on Out-of-Specification Test Results,” Pharmaceutical Formulation & Quality, November/ December 1999
“Navigating the FDA’s Fraud Policy and the Generic Drug Enforcement Act of 1992--Practical Considerations,” 51 Business Crime Commentary 1 (April 1993)
Monthly Newsletter on FDA regulation of pharmaceutical marketing and advertising, significant industry trends, Issues in Medical Marketing, 1992-94
“Tamper-Resistant Packaging: One Year Later,” Pharmaceutical Manufacturing, March, 1984
“Tylenol's Aftermath: Product Liability Implications,” American Bar Association Journal, March 1983
Note, “Shaffer v. Heitner and Rule B Maritime Attachment" 12 N.Y.U. J. INT’L. L. & POL 343 (1980)
Lectures on FDA Law and Regulation
Regular and highly reviewed lecturer internationally for the Center for Professional Innovation and Education (CfPIE) on regulation of pharmaceutical and medical device marketing, advertising and promotion.
Lecturer on FDA law and regulation at courses, seminars and conferences on FDA compliance issues; advertising, promotional and marketing programs; FDA inspections; Lanham Act issues at:
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Food and Drug Law Institute (FDLI)
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Weizmann Institute of Science, Israel
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Regulatory Affairs Professionals Society (RAPS)
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Drug Information Association (DIA)
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National Association of Pharmaceutical Manufacturers (NAPM)
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Global Business Communications
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International Business Communications (IBC)
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Biotechnology Trade Association
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Institute for International Research (IIR)
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New York State Bar Association, Food and Drug Section
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ISPE
For more information