Mann's pharmacovigilance / / edited by Elizabeth B. Andrews, Nicholas Moore ; Andrew Magee, cover design |
Edizione | [Third edition.] |
Pubbl/distr/stampa | Chichester, England : , : Wiley Blackwell, , 2014 |
Descrizione fisica | 1 online resource (876 p.) |
Disciplina | 363.19/463 |
Soggetto topico |
Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions Internationality Pharmacoepidemiology Product Surveillance, Postmarketing |
ISBN |
1-118-82018-5
1-118-82014-2 1-118-82017-7 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Cover; Title page; Copyright page; Contents; Contributors; Foreword; 1: Introduction: Updated from Second Edition; Background; Diagnosing Adverse Drug Reactions; Current Methods of Pharmacovigilance; Hypothesis-Generating Methods; Spontaneous Adverse Drug Reaction Reporting; Prescription-Event Monitoring; Other Hypothesis-Generating Methods; Hypothesis-Testing Methods; Conclusion; References; 2: History of Pharmacovigilance; Early History of Drug Safety; Recent History; Pre-1962; Turning Point: The Federal Food, Drug and Cosmetics Act; Gradual Increase in Regulatory Authority
Tectonic Shift: ThalidomidePost-Thalidomide Evolution of Regulation; United States of America; United Kingdom; Germany; Scandinavia; Japan; World Health Organization; France; Special Issues in Pharmacovigilance; Examples of Drugs that were Withdrawn from the Market; Bendectin; Thalidomide: Today's Approved Uses; Pharmacovigilance is Not Just for Regulators; References; Part I: The Regulatory Basis of Pharmacovigilance; 3: Legal Basis: European Union; Introduction; Reorganization of the European Union Regulatory System Obligations of being a Marketing Authorization Holder and being Granted a Marketing AuthorizationSignal Detection and Risk Management; Reporting Requirements; Transparency and Communication; Pharmacovigilance Enforcement; Further Information about Proposed New Legislation and Guidelines; 4: Ethical Oversight, Consent, and Confidentiality; Introduction; Practical Implications of Ethical Oversight; The Privacy and Security of Health Data; The Linkage of Electronic Health Data; The Conduct of Scientifically Sound Studies; Ethical Oversight and Privacy Law and Resulting Dilemmas; The Common Rule State LawsThe Health Insurance Portability and Accountability Act; Dilemmas Arising from the Health Insurance Portability and Accountability Act; Directions for Future Ethical Oversight and Privacy Provisions; References; 5: Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation1; Introduction; The International Conference on Harmonisation Step Process; ICH Step 1: Development of Draft Consensus ICH Guideline or Recommendations; ICH Step 2: Confirmation of Six Party Consensus; ICH Step 3: Regulatory Consultation ICH Step 4: Adoption of Tripartite ICH Guideline or RecommendationsICH Step 5: Implementation of ICH Guideline or Recommendations; Pharmacovigilance-Related International Conference on Harmonisation Topics; Topic ICH-E2A: Clinical Safety Data Management - Definitions and Standards for Expedited Reporting; ICH-E2D Topic: Post-Approval Safety Management - Definitions and Standards for Expedited Reporting; ICH-E2B Topic: Clinical Safety Data Management - Data Elements for Transmission of Individual Case Safety Reports ICH-E2C Topic: Clinical Safety Data Management - Periodic Benefit-Risk Evaluation Report (PBRER) |
Record Nr. | UNINA-9910139125403321 |
Chichester, England : , : Wiley Blackwell, , 2014 | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|
Mann's pharmacovigilance / / edited by Elizabeth B. Andrews, Nicholas Moore ; Andrew Magee, cover design |
Edizione | [Third edition.] |
Pubbl/distr/stampa | Chichester, England : , : Wiley Blackwell, , 2014 |
Descrizione fisica | 1 online resource (876 p.) |
Disciplina | 363.19/463 |
Soggetto topico |
Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions Internationality Pharmacoepidemiology Product Surveillance, Postmarketing |
ISBN |
1-118-82018-5
1-118-82014-2 1-118-82017-7 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Cover; Title page; Copyright page; Contents; Contributors; Foreword; 1: Introduction: Updated from Second Edition; Background; Diagnosing Adverse Drug Reactions; Current Methods of Pharmacovigilance; Hypothesis-Generating Methods; Spontaneous Adverse Drug Reaction Reporting; Prescription-Event Monitoring; Other Hypothesis-Generating Methods; Hypothesis-Testing Methods; Conclusion; References; 2: History of Pharmacovigilance; Early History of Drug Safety; Recent History; Pre-1962; Turning Point: The Federal Food, Drug and Cosmetics Act; Gradual Increase in Regulatory Authority
Tectonic Shift: ThalidomidePost-Thalidomide Evolution of Regulation; United States of America; United Kingdom; Germany; Scandinavia; Japan; World Health Organization; France; Special Issues in Pharmacovigilance; Examples of Drugs that were Withdrawn from the Market; Bendectin; Thalidomide: Today's Approved Uses; Pharmacovigilance is Not Just for Regulators; References; Part I: The Regulatory Basis of Pharmacovigilance; 3: Legal Basis: European Union; Introduction; Reorganization of the European Union Regulatory System Obligations of being a Marketing Authorization Holder and being Granted a Marketing AuthorizationSignal Detection and Risk Management; Reporting Requirements; Transparency and Communication; Pharmacovigilance Enforcement; Further Information about Proposed New Legislation and Guidelines; 4: Ethical Oversight, Consent, and Confidentiality; Introduction; Practical Implications of Ethical Oversight; The Privacy and Security of Health Data; The Linkage of Electronic Health Data; The Conduct of Scientifically Sound Studies; Ethical Oversight and Privacy Law and Resulting Dilemmas; The Common Rule State LawsThe Health Insurance Portability and Accountability Act; Dilemmas Arising from the Health Insurance Portability and Accountability Act; Directions for Future Ethical Oversight and Privacy Provisions; References; 5: Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation1; Introduction; The International Conference on Harmonisation Step Process; ICH Step 1: Development of Draft Consensus ICH Guideline or Recommendations; ICH Step 2: Confirmation of Six Party Consensus; ICH Step 3: Regulatory Consultation ICH Step 4: Adoption of Tripartite ICH Guideline or RecommendationsICH Step 5: Implementation of ICH Guideline or Recommendations; Pharmacovigilance-Related International Conference on Harmonisation Topics; Topic ICH-E2A: Clinical Safety Data Management - Definitions and Standards for Expedited Reporting; ICH-E2D Topic: Post-Approval Safety Management - Definitions and Standards for Expedited Reporting; ICH-E2B Topic: Clinical Safety Data Management - Data Elements for Transmission of Individual Case Safety Reports ICH-E2C Topic: Clinical Safety Data Management - Periodic Benefit-Risk Evaluation Report (PBRER) |
Record Nr. | UNINA-9910813194203321 |
Chichester, England : , : Wiley Blackwell, , 2014 | ||
![]() | ||
Lo trovi qui: Univ. Federico II | ||
|