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Food and drug regulation in an era of globalized markets

Publisher: Amsterdam ; Boston : Academic Press, an imprint of Elsevier, [2015]
Edition/Format:   Print book : EnglishView all editions and formats
Summary:
"This book 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  Read more...
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Document Type: Book
ISBN: 9780128023112 0128023112
OCLC Number: 907204600
Description: xli, 215 pages : illustrations, maps ; 23 cm
Contents: Addressing emerging challenges in the pharmaceutical product development ecosystem / Jesse Goodman --
FDA's global investigation and enforcement authority, partnerships, and priorities / Marc J. Scheineson --
European Medicines Agency and the regulation of medicines in the European Union / Sabine Haubenreisser, Martin Harvey-Allchurch --
Human clinical trials and drug approvals : transnational issues / Ben Haas, Shira N. Epstein --
Falsified and substandard medicines in globalized pharmaceutical supply chains : toward actionable solutions / Sam F. Halabi, Lawrence O. Gostin --
Regulatory capacity in low- and middle-income countries : lessons from H1N1 influenza pandemic / Sam F. Halabi, John Monahan --
Prime Minister Narenda Modi's government and its impact on the Indian pharmaceutical sector / Vince Suneja --
Regulatory challenges for medical devices and drugs under the China Food and Drug Administration / Gordon B. Schatz --
Balance between regulation and private-sector initiative in securing healthy and sustainable food / Eleanore Alexander, Derek Yach, Adriana Selwyn --
Divide and confound : the relationship between transparency, public health, and regulatory authority in the national food system / Lisa Heinzerling --
Global administrative law and the FDA's collaborative agreements with international regulatory partners / Sam F. Halabi --
Effective regulation of food additives / The Pew Charitable Trusts --
Protecting consumers through new regulations, inspection, and verification under the U.S. Food Safety Modernization Act / Chris Waldrop --
Evolving role of the Codex Alimentarius Commission in securing consumer protection in globalized food markets / Aliza Y. Glasner --
Emergence and influence of transnational private regulation of food safety / Ching-Fu Lin.
Responsibility: edited by Sam F. Halabi, The O'Neill Institute for National and Global Health Law, Georgetown University, Washington, DC, and The University of Tulsa College of Law, Tulsa, OK, USA.

Abstract:

"This book 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"--Publisher's website.

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