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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 / / edited by Sam F. Halabi |
| Pubbl/distr/stampa | London, England : , : Academic Press, , 2015 |
| Descrizione fisica | 1 online resource (258 p.) |
| Disciplina | 344.04233 |
| Soggetto topico |
Drugs - Law and legislation
Pharmacy - Law and legislation Food law and legislation |
| ISBN | 0-12-802550-6 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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 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 |
| Record Nr. | UNINA-9910797549503321 |
| London, England : , : Academic Press, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
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 / / edited by Sam F. Halabi |
| Pubbl/distr/stampa | London, England : , : Academic Press, , 2015 |
| Descrizione fisica | 1 online resource (258 p.) |
| Disciplina | 344.04233 |
| Soggetto topico |
Drugs - Law and legislation
Pharmacy - Law and legislation Food law and legislation |
| ISBN | 0-12-802550-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
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 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 |
| Record Nr. | UNINA-9910818197303321 |
| London, England : , : Academic Press, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Global management of infectious disease after ebola / / edited by Sam F. Halabi, Lawrence O. Gostin and Jeffrey S. Crowley
| Global management of infectious disease after ebola / / edited by Sam F. Halabi, Lawrence O. Gostin and Jeffrey S. Crowley |
| Pubbl/distr/stampa | New York, NY : , : Oxford University Press, , 2016 |
| Descrizione fisica | 1 online resource |
| Disciplina | 614.57 |
| Soggetto topico |
Ebola virus disease
Epidemics - Prevention |
| ISBN |
0-19-060490-5
0-19-060491-3 0-19-060489-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | The ebola epidemic of 2014-2015 : a perfect storm / Anthony S. Fauci -- Treating, containing, mobilizing : the role of Médecins sans frontières in the West Africa ebola epidemic response / Heather Pagano and Marc Poncin -- The effect of ebola virus disease on health outcomes and systems in Guinea, Liberia, and Sierra Leone / John D. Kraemer and Mark J. Siedner -- Infectious disease threats in high-resource settings : the MERS-CoV Outbreak in Korea / Sugy Choi, Jong Koo-Lee, and Daniel R. Lucey -- Antibiotic resistance / Gail Hansen -- The international health regulations : the governing framework for global health security / Lawrence O. Gostin and Rebecca Katz -- Global health diplomacy and the ebola outbreak / David P. Fidler -- The future of global financing for infectious diseases / Jen Kates and Adam Wexler -- International public-private partnerships as part of the solution to infectious disease threats : operational, legal, and governance considerations / Kevin A. Klock -- Global vaccine access as a critical intervention to fight infectious disease, antibiotic resistance, and poverty / Seth Berkley -- Bridging the gap between biomedical innovation and access to treatments to fight infectious disease / Veronica Miller -- Ethical challenges in the development and deployment of medical therapies and vaccines in the context of public health emergencies / Annick Antierens -- Evidence, strategies, and challenges for assuring vaccine availability, efficacy, and safety / Saad Omer and Sam Halabi -- An HIV vaccine / Mary Marovich -- Isolation, quarantine and infectious disease threats arising from global migration / Martin Cetron -- Epilogue / Renee Fox. |
| Record Nr. | UNINA-9910154737903321 |
| New York, NY : , : Oxford University Press, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||