TY  - BOOK
AU  - Cobert,Barton
AU  - Gregory,William W.
AU  - Thomas,Jean-Loup
AU  - Baldridge,Catherine
TI  - Cobert's manual of drug safety and pharmacovigilance
SN  - 9789819800216
AV  - Allied RM 302.5 C63 2025
PY  - 2025///
CY  - New Jersey
PB  - World Scientific
KW  - Drugs
KW  - Handbooks, manuals, etc
KW  - Pharmacoepidemiology
N1  - ch. 1. The history and theory of drug safety and pharmacovigilance. -- ch. 2. Primary definitions to safety & pharmacovigilance. -- ch. 3. Regulations, directives, guidance, laws and consensus documents. -- ch. 4. The United States Food and Drug Administration. -- ch. 5. The European Medicines Agency. -- ch. 6. Council for International Organizations of Medical Sciences (CIOMS). -- ch. 7. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). -- ch. 8. The Uppsala Monitoring Centre. -- ch. 9. Biopharmaceutical companies. -- ch. 10. The Safety Department's role in cross-functional areas. -- ch. 11. Organization of a typical drug safety department. -- ch. 12. Clinical trial phases and investigator-initiated trials. -- ch. 13. Data monitoring committees and investigational review boards/ethics committees. -- ch. 14. How an Individual Case Safety Report (ICSR) is handled from start to finish. -- ch. 15. Seriousness, expectedness, and causality. -- ch. 16. Coding of adverse events and drug names. -- ch. 17. Spontaneous post-marketing adverse events. -- ch. 18. Generics, excipients, placebos, and counterfeits. -- ch. 19. Artificial intelligence and pharmacovigilance. -- ch. 20. Expedited and aggregate reporting in clinical trials. -- ch. 21. Post-marketing spontaneous ICSR/SAE reporting. -- ch. 22. Post-marketing aggregate safety reporting. -- ch. 23. The mathematics of adverse events. -- ch. 24. Pharmacoepidemiology: its practical use in the world of drug safety. -- ch. 25. Signals and signaling in the context of risk management. -- ch. 26. Risk assessment, evaluation, management, mitigation, & strategy. -- ch. 27. Drug interactions. -- ch. 28. The many players in the world of pharmacovigilance. -- ch. 29. Pharmacovigilance system master file. -- ch. 30. The qualified (individual) person(s) responsible for pharmacovigilance. -- ch. 31. Product labeling. -- ch. 32. Business partners and exchange of safety data. -- ch. 33. Where data reside. -- ch. 34. Information technology and safety database. -- ch. 35. Data privacy and security. -- ch. 36. Children, elderly, and other special (vulnerable) groups. -- ch. 37. Acute and chronic (late occurring) adverse events, adverse events. -- ch. 38. Pregnancy and lactation. -- ch. 39. Product quality issues. -- ch. 40. Safety data volume, archival, record retention, and good documentation. -- ch. 41. PV quality system. -- ch. 42. Training. -- ch. 43. Audits and inspections. -- ch. 44. Ethical issues and conflicts of interests. -- ch. 45. Universities and academic medical centers. -- ch. 46. Vaccinovigilance. -- ch. 47. Real-world issues: case studies. -- ch. 48. Medical marijuana and pharmacovigilance
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