Food and drug regulation in an era of globalized markets / edited by Sam F. Halabi.
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 ph...
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Full Text (via ProQuest) |
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| Format: | eBook |
| Language: | English |
| Published: |
Amsterdam ; Boston :
Academic Press, an imprint of Elsevier,
[2015]
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Table of Contents:
- Front 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.
- Approaches 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.
- FDA 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.
- Cooperation 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.
- Deciding 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.