LEADER 05131nam 2200589 450 001 9910797549503321 005 20200520144314.0 010 $a0-12-802550-6 035 $a(CKB)3710000000468349 035 $a(EBL)2197878 035 $a(Au-PeEL)EBL2197878 035 $a(CaPaEBR)ebr11306155 035 $a(CaONFJC)MIL826972 035 $a(OCoLC)919611878 035 $a(NjHacI)993710000000468349 035 $a(MiAaPQ)EBC2197878 035 $a(PPN)19868634X 035 $a(EXLCZ)993710000000468349 100 $a20161202h20152015 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $2rdacontent 182 $2rdamedia 183 $2rdacarrier 200 00$aFood and drug regulation in an era of globalized markets /$fedited by Sam F. Halabi 210 1$aLondon, England :$cAcademic Press,$d2015. 210 4$dİ2015 215 $a1 online resource (258 p.) 300 $aIncludes index. 311 $a0-12-802311-2 327 $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 327 $aApproaches to Reduce Drug Development Costs and Speed Innovation Clinical 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 327 $aFDA Establishment Inspections FDA 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 327 $aCooperation in Inspections Benefits 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 327 $aDeciding Whether to Conduct the Foreign Clinical Trial Under an IND Identifying 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 327 $aCombating Falsified and Substandard Medicines through Regulatory Cooperation 330 $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' 606 $aDrugs$xLaw and legislation 606 $aPharmacy$xLaw and legislation 606 $aFood law and legislation 615 0$aDrugs$xLaw and legislation. 615 0$aPharmacy$xLaw and legislation. 615 0$aFood law and legislation. 676 $a344.04233 702 $aHalabi$b Sam F. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910797549503321 996 $aFood and drug regulation in an era of globalized markets$93794751 997 $aUNINA