دانلود کتاب راهنمای ایمنی دارو و مراقبت دارویی کوبرت
Cobert’s Manual Of Drug Safety And Pharmacovigilance 4th Edition

Cobert’s Manual of Drug Safety and Pharmacovigilance, Fourth Edition, is an updated how-to manual of guiding principles and concepts for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions.

This comprehensive and practical guide discusses the theory and the practicalities of drug safety and pharmacovigilance, and provides essential information on drug safety and regulations in the United States, European Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.

Cobert’s Manual of Drug Safety and Pharmacovigilance, Fourth Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies — both in the United States and around the world — and provides critical information about what to do when confronted with a drug safety problem.

Contents

۱. The History and Theory of Drug Safety and Pharmacovigilance
۲. Primary definitions relevant to Safety & Pharmacovigilance
۳. Regulations, Directives, Guidance, Laws and Consensus Documents
۴. The United States Food and Drug Administration
۵. The European Medicines Agency
۶. Council for International Organizations of Medical Sciences (CIOMS)
۷. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)
۸. The Uppsala Monitoring Centre
۹. Biopharmaceutical Companies
۱۰. The Safety Department’s Role in Cross-Functional areas
۱۱. Organization of a Typical Drug Safety Department
۱۲. Clinical Trial Phases and Investigator-Initiated Trials
۱۳. Data Monitoring Committees and Investigational Review Boards/Ethics Committees
۱۴. How an Individual Case Safety Report (ICSR) is Handled from Start to Finish
۱۵. Seriousness, Expectedness, and Causality
۱۶. Coding of Adverse Events and Drug Names
۱۷. Spontaneous Post-marketing Adverse Events
۱۸. Generics, Excipients, Placebos, and Counterfeits
۱۹. Artificial Intelligence and Pharmacovigilance
۲۰. Expedited and Aggregate Reporting in Clinical Trials
۲۱. Post-marketing Spontaneous ICSR/SAE Reporting
۲۲. Post-marketing Aggregate Safety Reporting
۲۳. The Mathematics of Adverse Events
۲۴. Pharmacoepidemiology. Its Practical Use in the World of Drug Safety
۲۵. Signals and Signaling in the Context of Risk Management
۲۶. Risk Assessment, Evaluation, Management, Mitigation, & Strategy
۲۷. Drug Interactions
۲۸. The Many Players in the World of Pharmacovigilance
۲۹. Pharmacovigilance System Master File
۳۰. The Qualified (Individual) Person(s) Responsible for Pharmacovigilance
۳۱. Product Labeling
۳۲. Business Partners and Exchange of Safety Data
۳۳. Where Data Reside
۳۴. Information Technology and the Safety Database
۳۵. Data Privacy and Security
۳۶. Children, Elderly, and Other Special (Vulnerable) Groups
۳۷. Acute and Chronic (Late Occurring) Adverse Events, Adverse Events That Disappear
۳۸. Pregnancy and Lactation
۳۹. Product Quality Issues
۴۰. Safety Data Volume, Archival, Record Retention, and Good Documentation Procedures
۴۱. PV Quality System
۴۲. Training
۴۳. Audits and Inspections
۴۴. Ethical Issues and Conflicts of Interest
۴۵. Universities and Academic Medical Centers
۴۶. Vaccinovigilance
۴۷. Real-World Issues. Case Studies
۴۸. Medical Marijuana and Pharmacovigilance