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Record Nr. |
UNINA9910797549503321 |
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Titolo |
Food and drug regulation in an era of globalized markets / / edited by Sam F. Halabi |
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Pubbl/distr/stampa |
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London, England : , : Academic Press, , 2015 |
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©2015 |
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ISBN |
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Descrizione fisica |
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1 online resource (258 p.) |
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Disciplina |
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Soggetti |
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Drugs - Law and legislation |
Pharmacy - Law and legislation |
Food law and legislation |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Nota di contenuto |
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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 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 |
FDA Establishment Inspections FDA Enforcement Instruments Related to Manufacturing; Foreign Inspections; Conclusion; Chapter 3: The |
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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 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 |
Deciding 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 |
Combating Falsified and Substandard Medicines through Regulatory Cooperation |
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Sommario/riassunto |
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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 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' |
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2. |
Record Nr. |
UNICAMPANIAVAN00252407 |
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Autore |
Del Bagno, Ileana |
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Titolo |
Da incapaci a disabili : minorati sensoriali e cultura dei diritti / Ileana Del Bagno |
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Pubbl/distr/stampa |
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Torino, : Giappichelli, 2021 |
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Titolo uniforme |
Da incapaci a disabili |
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ISBN |
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Descrizione fisica |
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Soggetti |
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Disabili - Tutela - Italia - Diritto |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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3. |
Record Nr. |
UNINA9910557706703321 |
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Autore |
De Martinis Domenico |
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Titolo |
Next Generation Agriculture: Understanding Plant Life for Food, Health and Energy |
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Pubbl/distr/stampa |
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Descrizione fisica |
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1 online resource (247 p.) |
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Soggetti |
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Botany & plant sciences |
Science: general issues |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Sommario/riassunto |
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This eBook is a collection of articles from a Frontiers Research Topic. Frontiers Research Topics are very popular trademarks of the Frontiers Journals Series: they are collections of at least ten articles, all centered |
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on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area! Find out more on how to host your own Frontiers Research Topic or contribute to one as an author by contacting the Frontiers Editorial Office: frontiersin.org/about/contact |
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