Events

Webinar: Clinical Trials Privacy Issues

In a must-attend series of webinars offered at no cost, entrepreneurs and owners of emerging life sciences companies will learn how to craft the cost-efficient legal strategies required to start, develop and maximize the value of their businesses.

CHI presents The Blueprint™ in collaboration with Duane Morris, a global law firm focused on the emerging life sciences space. The Blueprint™ provides a step-by-step guide to establishing and financing your business; obtaining, protecting and partnering your intellectual property; dealing with FDA regulations; maintaining effective employment practices; recognizing and minimizing risk; and ensuring continued success once on the market.

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This week’s topic: Clinical Trials Privacy Issues presented by Michael Swit of Duane Morris.

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About the Presenter

Michael A. Swit’s practice focuses on solving the legal challenges confronted by the pharmaceutical, medical device, and other life sciences industries in tackling the myriad of legal mandates enforced by the U.S. Food & Drug Administration. Mr. Swit has extensive experience counseling life sciences firms on the demands of compliance with FDA’s statutory and regulatory requirements to develop and market safe and effective drugs, biologics, medical devices, IVDs and other products. He also has advised regulated firms on a wide range of FDA regulatory matters, including drug and device approvals, food labeling and safety issues, dietary supplement health claims, and regulatory issues in corporate acquisitions. His experience includes FDA development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts.

Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. Before joining Duane Morris LLP, Mr. Swit served for seven years as vice president at a preeminent scientific and FDA regulatory consulting firm, where he developed and ensured execution of a broad array of regulatory and other services to clients, both directly and through outside counsel.

His multi-faceted experience includes serving for three and a half years as corporate vice president, general counsel and secretary of Par Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and commercial perspective to his work with FDA-regulated companies. While at Par, he spearheaded Par’s successful response to multiple federal and state criminal and civil investigations arising out of the actions of prior management. Mr. Swit then served for over four years as CEO of FDAnews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA-regulated community. His private FDA regulatory law practice also has included service as counsel in the FDA practices of three international law firms, as well as a solo FDA practitioner.

Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the Food & Drug Law Journal Editorial Board, Mr. Swit also has been a prominent speaker at numerous conferences sponsored by such organizations as the Food & Drug Law Institute (FDLI), the Regulatory Affairs Professionals Society (RAPS), and the Drug Information Association (DIA).

Mr. Swit is a 1982 graduate of Emory School of Law and a magna cum laude graduate of Bowdoin College (1979), with high honors in history.

About The Blueprint:

The Blueprint™ will unfold as a series of 12 webinars, to be held on alternate Tuesdays from 9:00 a.m. to 10:00 a.m. (Pacific time). Take advantage of this unique opportunity to leverage your concept, whether in biotech, pharma, medical devices, diagnostics, wireless health, informatics or other areas.
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The Blueprint™ will unfold as a series of 12 webinars, to be held on alternate Tuesdays from 9:00 a.m. to 10:00 a.m. (Pacific time). Take advantage of this unique opportunity to leverage your concept, whether in biotech, pharma, medical devices, diagnostics, wireless health, informatics or other areas.

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