Food and Drug Regulation in an Era of Globalized Markets (eBook)

Sam F Halabi (Herausgeber)

eBook Download: PDF | EPUB

2015 | 1. Auflage
264 Seiten
Elsevier Science (Verlag)
978-0-12-802550-5 (ISBN)

Infos

Food and Drug Regulation in an Era of Globalized Markets provides a synthesized look at the pressures that are impacting today's markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing pharmaceutical sectors in China and India. From the changing nature of packaged and processed food supply chains, to the reorientation of pharmaceutical research and funding coalesced to confront firms, regulators, and consumers are now faced with previously unknown challenges. Based on the 2014 O'Neill Institute Summer program, this book provides an international, cross-disciplinary look at the changing world of regulations and offers insights into requirements for successful implementation. - Interdisciplinary approach allows readers to understand the varying perspectives involved in regulatory development - Includes case studies to highlight harmonization efforts and challenges, and to provide practical insights for application going forward - Provides a thorough assessment of supply chains, potential gaps, and means of anticipating and addressing issues - Presents a comprehensive snapshot of changes in the food safety law in the United States and under international standards, including academic, industry and regulatory perspectives - Addresses conflicts and cooperation between relevant US agencies including USDA, FDA, DEA, EPA, FTC and the Department of Commerce

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Contributors

Elle Alexander

Policy Analyst, The Vitality Institute

Ms. Alexander’s work at the Vitality Institute centers on research, and engaging with stakeholders in the business, NGO, and scientific community. She leads the Vitality Institute’s Research and Development partnerships and projects to bring the best evidence on chronic disease risk reduction into practice. Ms. Alexander completed her MSPH in human nutrition at Johns Hopkins Bloomberg School of Public Health. While at John Hopkins, she worked on the Baltimore Healthy Eating Zones (BHEZ) project to promote healthy eating behaviors in youth through interventions in corner stores and recreation centers. Following her MSPH, Ms. Alexander worked at PepsiCo as a policy analyst on the global health and agriculture policy team to promote collaborative solutions for improving nutrition and reducing chronic disease risk factors. Ms. Alexander holds a Bachelor of Science in psychology, and an International Relations certificate from the University of Massachusetts Amherst.

Shira Epstein

Associate, Latham & Watkins, LLP

Shira Epstien is an associate in the Washington, D.C. office of Latham & Watkins. Ms. Epstien specializes in litigation, investigations, and compliance matters in the healthcare industry. Ms. Epstien’s practice focuses on counseling hospital, pharmaceutical, medical device, food, and other related industry clients with respect to regulatory issues involving the Centers for Medicare and Medicaid Services, and the Food and Drug Administration. She has also advised clients in matters pertaining to violations of the False Claims Act.

Ms. Epstien received her J.D. from Georgetown University Law Center, and her Master of public policy degree from the Harvard Kennedy School. In addition to her legal training at Georgetown, Ms. Epstien studied transnational law at the Center for Transnational Legal Studies in London.

Aliza Glasner

Institute Associate, O’Neill Institute for National and Global Health Law

Aliza Glasner is an O’Neill Institute Associate. Ms. Glasner’s primary focus is on food and drug law. Before joining O’Neill, she was the manager of Product Development at the Food and Drug Law Institute in Washington, D.C. There, she worked in collaboration with industry and government experts to develop programs and publications addressing legal, policy, and regulatory issues in the food and drug sector. Ms. Glasner was also responsible for planning international events, including FDLI’s inaugural conference in Beijing, China, which focuses on issues related to trade, compliance, and safety in the food and drug sector. She previously practiced law at Cadwalader, Wickersham & Taft in New York. Ms. Glasner holds a law degree from Fordham University and a B.A. in international affairs from the George Washington University.

Jesse Goodman

Director, Center on Medical Product Access, Safety and Stewardship (COMPASS), Georgetown University Medical Center; Former Chief Scientist, US Food and Drug Administration

Jesse L. Goodman, MD, MPH, is the founding director of the Center on Medical Product Access, Safety and Stewardship (COMPASS) at Georgetown University Medical Center. The Center studies three broad areas of U.S. and global public health importance: medical product safety and security across the global manufacturing supply chain, antimicrobial drug resistance, and access to lifesaving medical products. Goodman, a member of the Institute of Medicine, was most recently the chief scientist for the U.S. Food and Drug Administration (FDA), and is a renowned expert in infectious diseases. In addition to leading COMPASS, Dr. Goodman is an attending physician at the Washington D.C. VA Medical Center and MedStar Georgetown University Hospital. Prior to joining the FDA, Dr. Goodman was director of the division of infectious diseases and professor of medicine at the University of Minnesota, where his National Institutes of Health-funded laboratory isolated and characterized the causative agent of a new tick-borne disease, known as human granulocytic anaplasmosis. He received his AB in biology from Harvard College, his MD from the Albert Einstein College of Medicine, and his MPH from the University of Minnesota.

Lawrence O. Gostin

Linda D. & Timothy J. O’Neill Professor of Global Health Law; Faculty Director, O’Neill Institute for National & Global Health Law; Director, World Health Organization Collaborating Center on Public Health Law & Human Rights, University Professor

Lawrence O. Gostin is professor of medicine at Georgetown University, professor of public health at the Johns Hopkins University, and director of the Center for Law & the Public’s Health at Johns Hopkins and Georgetown Universities. Prof. Gostin holds a number of international academic professorial appointments: visiting professor (faculty of medical sciences) and research fellow (Centre for Socio-Legal Studies) at the University of Oxford, United Kingdom; the Claude Leon Foundation Distinguished Scholar and visiting professor at the University of Witwatersrand, Johannesburg, South Africa; and the Miegunyah distinguished visiting fellow, and founding fellow of the Centre for Advanced Studies (Trinity College), University of Melbourne. Prof. Gostin serves as secretary and a member of the Governing Board of Directors of the Consortium of Universities for Global Health. Prof. Gostin is the director of the World Health Organization Collaborating Center on Public Health Law & Human Rights. He also serves on the WHO Director-General’s Advisory Committee on Reforming the World Health Organization. In 2007, the WHO Director-General appointed Prof. Gostin to the International Health Regulations (IHR) Roster of Experts and the Expert Advisory Panel on Mental Health.

Prof. Gostin holds numerous editorial appointments in leading academic journals throughout the world. His principal position is the health, law, and ethics editor, contributing writer, and columnist for the Journal of the American Medical Association. He is also founding editor-in-chief of Laws (an international, open-access, law journal). He was formerly the editor-in-chief of the Journal of Law, Medicine & Ethics. He holds a B.A. from the State University of New York, Brockport; a JD from Duke University; an LLD (Hon.) from the State University of New York; and an LLD (Hon.) from the University of Sydney. Prof. Gostin, an elected lifetime member of the Institute of Medicine/National Academy of Sciences, serves on the Board on Health Sciences Policy, the Human Subjects Review Board, and the Committee on Science, Technology, and Law. He currently chairs the IOM Committee on Global Solutions to the Challenge of Counterfeit Medicines.

J. Benneville (Ben) Haas

Partner, Latham & Watkins

Ben Haas practices in Latham & Watkins’ Washington, D.C. office, where he is a corporate partner in the healthcare and life sciences practice group. Mr. Haas focuses his practice on regulatory, transactional, and legislative matters involving the medical device, pharmaceutical, biotechnology, tobacco, food, cosmetic, and dietary supplement industries. Mr. Haas has counseled clients on a wide variety of regulatory matters involving the U.S. Food and Drug Administration (FDA). In the transactional arena, Mr. Haas provides counsel on corporate compliance, mergers and acquisitions, and other corporate transactions. He regularly assists pharmaceutical and medical device companies in initiating, managing, and completing large, international clinical trials. He has counseled clients regarding clinical trial strategy; contracting with and managing clinical research organizations, other clinical trial vendors, and clinical trial sites and investigators in the United States, and in dozens of overseas jurisdictions; and communicating with U.S. and foreign regulatory authorities, as well as institutional review boards and ethics committees, both domestic and foreign. Mr. Haas has also drafted and negotiated several types of agreements for healthcare clients, including manufacturing and supply, licensing, joint development, consulting and marketing, and distribution contracts. Mr. Haas has conducted regulatory diligence for major public and private financings, mergers, and other transactions in the device, pharmaceutical, and dietary supplement industries. Mr. Haas also counsels clients on legislative and administrative rulemaking proceedings relating to the FDA, including issues resulting from the implementation of the Family Smoking Prevention and Tobacco Control Act of 2009, the Food and Drug Administration Amendments Act of 2007, the Medical Device User Fee and Modernization Act of 2002, the Bioterrorism Act of 2002, and the Medicare Prescription Drug Improvement and Modernization Act of 2003. He has worked extensively with trade associations and other clients to address specific regulatory issues in matters before several federal agencies, including the Environmental Protection Agency, Federal Trade Commission, Department of Transportation, U.S. Department of Agriculture and Drug Enforcement Administration. Mr. Haas has authored, and co-authored, articles on FDA regulatory matters, including articles in the Food and Drug Law Institute’s Update Magazine and the Pharmaceutical Law & Industry Report, and has been a featured speaker and...

Produkt-Details

• Erscheint lt. Verlag: 31.8.2015
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Pflege
• Themenwelt: Medizin / Pharmazie ► Pharmazie ► PTA / PKA
• Themenwelt: Naturwissenschaften ► Biologie
• Themenwelt: Recht / Steuern ► Allgemeines / Lexika
• Themenwelt: Recht / Steuern ► EU / Internationales Recht
• Themenwelt: Recht / Steuern ► Öffentliches Recht
• Themenwelt: Recht / Steuern ► Privatrecht / Bürgerliches Recht ► Medizinrecht
• Themenwelt: Sozialwissenschaften ► Soziologie
• Themenwelt: Technik ► Lebensmitteltechnologie
• Themenwelt: Wirtschaft ► Betriebswirtschaft / Management ► Logistik / Produktion
• Themenwelt: Wirtschaft ► Volkswirtschaftslehre ► Makroökonomie
• ISBN-10: 0-12-802550-6 / 0128025506
• ISBN-13: 978-0-12-802550-5 / 9780128025505