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El comercio internacional de medicamentos / / Carmen Otero García-Castrillón
| El comercio internacional de medicamentos / / Carmen Otero García-Castrillón |
| Autore | Otero García-Castrillón Carmen |
| Pubbl/distr/stampa | Madrid : , : Dykinson, , [2006] |
| Descrizione fisica | 1 online resource (295 páginas) |
| Disciplina | 610 |
| Soggetto topico |
Medicamentos - Comercio
Medicamentos - Patentes Medicamentos - Derecho y legislación Generic drugs - Law and legislation Pharmacy - Law and legislation Farmacia - Derecho y legislaciØn |
| Soggetto genere / forma | Libros electronicos. |
| ISBN |
84-9772-847-5
84-9982-367-X |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | spa |
| Record Nr. | UNINA-9910671117703321 |
Otero García-Castrillón Carmen
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| Madrid : , : Dykinson, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Competences for Pharmacy Education and Practice in Europe / / edited by Jeff Atkinson
| Competences for Pharmacy Education and Practice in Europe / / edited by Jeff Atkinson |
| Pubbl/distr/stampa | Basel, Switzerland : , : MDPI, , 2018 |
| Descrizione fisica | 1 online resource (158 pages) |
| Disciplina | 610 |
| Soggetto topico | Pharmacy - Law and legislation |
| ISBN | 3-03897-094-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910688426203321 |
| Basel, Switzerland : , : MDPI, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Compulsory licensing for public health [[electronic resource] ] : a guide and model documents for implementation of the Doha Declaration paragraph 6 decision / / Frederick M. Abbott and Rudolf V. Van Puymbroeck
| Compulsory licensing for public health [[electronic resource] ] : a guide and model documents for implementation of the Doha Declaration paragraph 6 decision / / Frederick M. Abbott and Rudolf V. Van Puymbroeck |
| Autore | Abbott Frederick M |
| Pubbl/distr/stampa | Washington, DC, : World Bank, 2005 |
| Descrizione fisica | 1 online resource (80 p.) |
| Disciplina | 344.04 |
| Altri autori (Persone) | Van PuymbroeckRudolf V. <1945-> |
| Collana | World Bank working paper |
| Soggetto topico |
Compulsory licensing of patents
Drugs Drugs - Law and legislation Pharmacy - Law and legislation Public health laws, International Public health - Developing countries |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-17719-5
9786610177196 0-8213-6293-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Contents; Foreword; Abstract; Acknowledgments; Introduction; Part I; The Doha Declaration and the Paragraph 6 Decision-A Concise Explanation; Part II; Model Legal Documents; Document 1: Notification by Developing Country Member to Council for TRIPS of Intention to use System as Importer:; Document 2: Importation under the Paragraph 6 Decision: Notification by Least-Developed Country Member; Document 3: Importation under the Paragraph 6 Decision: Notification by Developing Country Member; Document 4: Notification to Right Holder of Issuance of Compulsory License
Document 5: Patent Act Amendment for ExportingDocument 6: Patent Act Amendment for Importing; Appendixes; A. Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health; B. General Council Chairperson's Statement; C. Declaration on the TRIPS Agreement and Public Health; D. Agreement on Trade-Related Aspects of Intellectual Property Rights, Article 31-Other Use Without Authorization of the Right Holder |
| Record Nr. | UNINA-9910450396703321 |
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Abbott Frederick M
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| Washington, DC, : World Bank, 2005 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Compulsory licensing for public health : : a guide and model documents for implementation of the Doha Declaration paragraph 6 decision / / Frederick M. Abbott, Rudolf V. Van Puymbroeck
| Compulsory licensing for public health : : a guide and model documents for implementation of the Doha Declaration paragraph 6 decision / / Frederick M. Abbott, Rudolf V. Van Puymbroeck |
| Autore | Abbott Frederick M |
| Pubbl/distr/stampa | Washington, D.C. : , : World Bank, , c2005 |
| Descrizione fisica | ix, 64 pages ; ; 26 cm |
| Disciplina | 344.04 |
| Altri autori (Persone) | Van PuymbroeckRudolf V. <1945-> |
| Collana | World Bank working paper |
| Soggetto topico |
Compulsory licensing of patents
Drugs Drugs - Law and legislation Pharmacy - Law and legislation Public health laws, International Public health - Developing countries |
| ISBN |
1-280-17719-5
9786610177196 0-8213-6293-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Contents; Foreword; Abstract; Acknowledgments; Introduction; Part I; The Doha Declaration and the Paragraph 6 Decision-A Concise Explanation; Part II; Model Legal Documents; Document 1: Notification by Developing Country Member to Council for TRIPS of Intention to use System as Importer:; Document 2: Importation under the Paragraph 6 Decision: Notification by Least-Developed Country Member; Document 3: Importation under the Paragraph 6 Decision: Notification by Developing Country Member; Document 4: Notification to Right Holder of Issuance of Compulsory License
Document 5: Patent Act Amendment for ExportingDocument 6: Patent Act Amendment for Importing; Appendixes; A. Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health; B. General Council Chairperson's Statement; C. Declaration on the TRIPS Agreement and Public Health; D. Agreement on Trade-Related Aspects of Intellectual Property Rights, Article 31-Other Use Without Authorization of the Right Holder |
| Record Nr. | UNINA-9910783341303321 |
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Abbott Frederick M
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| Washington, D.C. : , : World Bank, , c2005 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Compulsory licensing for public health : : a guide and model documents for implementation of the Doha Declaration paragraph 6 decision / / Frederick M. Abbott, Rudolf V. Van Puymbroeck
| Compulsory licensing for public health : : a guide and model documents for implementation of the Doha Declaration paragraph 6 decision / / Frederick M. Abbott, Rudolf V. Van Puymbroeck |
| Autore | Abbott Frederick M |
| Pubbl/distr/stampa | Washington, D.C. : , : World Bank, , c2005 |
| Descrizione fisica | ix, 64 pages ; ; 26 cm |
| Disciplina | 344.04 |
| Altri autori (Persone) | Van PuymbroeckRudolf V. <1945-> |
| Collana | World Bank working paper |
| Soggetto topico |
Compulsory licensing of patents
Drugs Drugs - Law and legislation Pharmacy - Law and legislation Public health laws, International Public health - Developing countries |
| ISBN |
1-280-17719-5
9786610177196 0-8213-6293-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Contents; Foreword; Abstract; Acknowledgments; Introduction; Part I; The Doha Declaration and the Paragraph 6 Decision-A Concise Explanation; Part II; Model Legal Documents; Document 1: Notification by Developing Country Member to Council for TRIPS of Intention to use System as Importer:; Document 2: Importation under the Paragraph 6 Decision: Notification by Least-Developed Country Member; Document 3: Importation under the Paragraph 6 Decision: Notification by Developing Country Member; Document 4: Notification to Right Holder of Issuance of Compulsory License
Document 5: Patent Act Amendment for ExportingDocument 6: Patent Act Amendment for Importing; Appendixes; A. Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health; B. General Council Chairperson's Statement; C. Declaration on the TRIPS Agreement and Public Health; D. Agreement on Trade-Related Aspects of Intellectual Property Rights, Article 31-Other Use Without Authorization of the Right Holder |
| Record Nr. | UNINA-9910814310703321 |
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Abbott Frederick M
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| Washington, D.C. : , : World Bank, , c2005 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Doctor Badger's vindication of himself [[electronic resource] ] : from the groundless calumnies and malicious slanders, of some London-apothecaries. To Mr. Peter Gelsthorpe, present master, Mr. Thomas Gardner, master elect; [bracket] of the Worshipful Company of Apothecaries, and to the other gentlemen of the Court of Assistants
| Doctor Badger's vindication of himself [[electronic resource] ] : from the groundless calumnies and malicious slanders, of some London-apothecaries. To Mr. Peter Gelsthorpe, present master, Mr. Thomas Gardner, master elect; [bracket] of the Worshipful Company of Apothecaries, and to the other gentlemen of the Court of Assistants |
| Autore | Badger John <fl. 1693.> |
| Pubbl/distr/stampa | [London, : s.n.], 1701 |
| Descrizione fisica | 1 sheet ([2] p.) |
| Soggetto topico |
Pharmacists
Pharmacy - Law and legislation |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNISA-996395593303316 |
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Badger John <fl. 1693.>
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| [London, : s.n.], 1701 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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European pharmaceutical law review
| European pharmaceutical law review |
| Pubbl/distr/stampa | Berlin : , : Lexxion Verlagsgesellschaft mbH, , [2017]- |
| Disciplina | 344.0416 |
| Soggetto topico |
Pharmacy - Law and legislation - European Union countries
Drugs - Law and legislation - European Union countries Drugs - Law and legislation Pharmacy - Law and legislation |
| Soggetto genere / forma | Periodicals. |
| ISSN | 2511-7181 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | EPLR |
| Record Nr. | UNINA-9910293342403321 |
| Berlin : , : Lexxion Verlagsgesellschaft mbH, , [2017]- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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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 | ||
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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-9910818197303321 |
| London, England : , : Academic Press, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Journal of GXP compliance
| Journal of GXP compliance |
| Pubbl/distr/stampa | Royal Palm Beach, FL, : Institute of Validation Technology |
| Disciplina | 353.9/97/097305 |
| Soggetto topico |
Pharmacy - Law and legislation - United States
Medical instruments and apparatus industry - Law and legislation - United States Food law and legislation - United States Pharmaceutical Preparations - standards Clinical Trials as Topic - standards Drug and Narcotic Control - legislation & jurisprudence Equipment and Supplies - standards Quality Control Food law and legislation Medical instruments and apparatus industry - Law and legislation Pharmacy - Law and legislation |
| Soggetto genere / forma |
Periodical
Periodicals. |
| ISSN | 2150-6590 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | GXP compliance |
| Record Nr. | UNISA-996209185003316 |
| Royal Palm Beach, FL, : Institute of Validation Technology | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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