edited by Sam F. Halabi. -- Academic Press, -- c2015. --

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ISBN 0128023112
ISBN13桁 9780128023112
テキストの言語 英語                  
分類:NDC10版 499
本タイトル Food and drug regulation in an era of globalized markets /
著者名 edited by Sam F. Halabi.
出版地・頒布地 Amsterdam ;
出版者・頒布者名 Academic Press,
出版年・頒布年 c2015.
数量 xli, 215 p. :
他の形態的事項 ill., maps ;
大きさ 23 cm.
書誌注記 Includes bibliographical references and index.
内容注記 Addressing emerging challenges in the pharmaceutical product development ecosystem / Jesse Goodman -- FDA's global investigation and enforcement authority, partnerships, and priorities / Marc J. Scheineson -- The 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 -- The 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.
要約、抄録、注釈等 "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.
著者標目 Halabi, Sam F.
一般件名 Drugs -- Law and legislation.
Pharmacy -- Law and legislation.
資料情報1 『Food and drug regulation in an era of globalized markets /』 edited by Sam F. Halabi. Academic Press,  c2015. (所蔵館:中央  請求記号:F/499.0/F68/F  資料コード:7106471689)
URL https://catalog.library.metro.tokyo.lg.jp/winj/opac/switch-detail.do?lang=ja&bibid=1352017624