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020 _a0128025506
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020 _z9780128023112
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050 4 _aK3636.F66
072 7 _aLAW
082 0 4 _a344.0423
_223
245 0 0 _aFood and drug regulation in an era of globalized markets /
_cedited by Sam F. Halabi.
264 1 _aAmsterdam ;
_aBoston :
_bAcademic Press, an imprint of Elsevier,
_c[2015]
264 4 _c©2015
300 _a1 online resource
336 _atext
_btxt
_2rdacontent
337 _acomputer
_bc
_2rdamedia
338 _aonline resource
_bcr
_2rdacarrier
347 _atext file
504 _aIncludes bibliographical references and index.
505 0 _aFront Cover; Food and Drug Regulation in an Era of Globalized Markets; Copyright; Contents; Contributors; Foreword; Introduction; The Rise of a Global System for Food and Pharmaceuticals; Conceptualizing Food and Drug Regulation in Globalized Markets: Interdisciplinarity and Governance; The Plan of This Book; Acknowledgments; Acknowledgments; Part I: Governance, Regulation, and Vulnerabilities of Globalized Pharmaceutical Supply Chains ; Chapter 1: Addressing Emerging Challenges in the Pharmaceutical Product Development Ecosystem; Introduction.
505 8 _aApproaches to Reduce Drug Development Costs and Speed InnovationClinical Trials: Reducing Costs, Speeding Development: New Approaches to Patient Recruitment, Study Design, and Settings; Adaptive Design; Clinical Trials: Globalization; New Approaches to Endpoints: Biomarkers, Patient Reporting, and Remote Monitoring; The Supply Chain: How Are We Vulnerable and What Are Potential Solutions?; Big (More and More) Data: Swim or Drown?; Conclusion; Chapter 2: FDA's Global Investigation and Enforcement Authority, Partnerships, and Priorities; Introduction; Adulteration, Misbranding, and GMPs.
505 8 _aFDA Establishment InspectionsFDA Enforcement Instruments Related to Manufacturing; Foreign Inspections; Conclusion; Chapter 3: The European Medicines Agency and the Regulation of Medicines in the European Union; Introduction; Approval of Drugs in Europe; The European Medicines Agency: Its Role and Activities; Ema Support In The Early Stages Of Drug Development; The Centralized Procedure AT WORK; Assessment overview; Single Assessment Report; Patients in the Scientific Review Process; Transparency and the Centralized Procedure; EMA-FDA Cooperation; Cooperation in the Product Life Cycle.
505 8 _aCooperation in InspectionsBenefits of International Cooperation; References; Chapter 4: Human Clinical Trials and Drug Approvals: Transnational Issues; Introduction; Taking Clinical Trials Abroad; Overlapping Legal and Regulatory Requirements; Legal Landscape in the United States: FDA Oversight of Clinical Trials; Legal Landscape in the EU: EU Clinical Trial Directives and Regulation; International Legal Landscape: International Clinical Practice Standards; National and Local Legal Standards; Practical Considerations in Conducting Global Trials.
505 8 _aDeciding Whether to Conduct the Foreign Clinical Trial Under an INDIdentifying Experienced Contractors and Contract Research Organizations; Managing Idiosyncratic Foreign Sites and Investigators; Conclusion; Further Reading; Chapter 5: Falsified and Substandard Medicines in Globalized Pharmaceutical Supply Chains: Toward Actionable Solutions; Globalization's Influence on the Pharmaceutical Supply Chain; The Effects of the Global Market for Falsified and Substandard Medicines; Barriers to Global Solutions for the Problem of Falsified and Substandard Medicines.
520 _aFood 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.
588 0 _aVendor-supplied metadata.
650 0 _aDrugs
_xLaw and legislation.
_963786
650 0 _aPharmacy
_xLaw and legislation.
_963787
650 0 _aFood law and legislation.
_963788
650 7 _aLAW
_xAdministrative Law & Regulatory Practice.
_2bisacsh
_963789
650 7 _aDrugs
_xLaw and legislation.
_2fast
_0(OCoLC)fst00898830
_963790
650 7 _aFood law and legislation.
_2fast
_0(OCoLC)fst00930954
_963791
650 7 _aPharmacy
_xLaw and legislation.
_2fast
_0(OCoLC)fst01060303
_963792
700 1 _aHalabi, Sam F.,
_eeditor.
_963793
776 0 8 _iPrint version:
_tFood and drug regulation in an era of globalized markets.
_dLondon, England : Academic Press, ©2015
_hxli, 215 pages
_z9780128023112
856 4 0 _3ELSEVIER
_uhttps://www.sciencedirect.com/science/book/9780128023112
942 _2ddc
_cEBK
999 _c85040
_d85040