Good practices for handling adverse events detected through patient registries

Drug Information Journal

Volumn 42, Issue 5, 2008, Pages 421-428

  Dreyer, Nancy A ^a   Sheth, Neha ^b   Trontell, Anne ^c   Gliklich, Richard E ^a  

^a Outcome Sciences Inc   (United States)

^b PFIZER INC   (United States)

^c AGENCY FOR HEALTHCARE RESEARCH AND QUALITY   (United States)

Author keywords

Adverse event reporting; Registries; SAE

Indexed keywords

PARACETAMOL;

ARTICLE; DRUG INDUSTRY; DRUG MONITORING; DRUG SURVEILLANCE PROGRAM; GOOD CLINICAL PRACTICE; MEDICAL DOCUMENTATION; OUTCOME ASSESSMENT; PATIENT INFORMATION; PRIORITY JOURNAL; REGISTER;

EID: 53849084855     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150804200502     Document Type: Article

References (21)

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5. Code of Federal Regulations. 21 CFR 314.80.
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10. See http://www.fda.gov/medwatch/SAFETY for summaries of new safety information.
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12. See Code of Federal Regulations, 21 CFR 314.80.
13. US Food and Drug Administration. MedWatch. Available at: www.fda.gov/ medwatch.
14. Vaccine Adverse Event Reporting System. Available at: http://vaers.hhs.gov.
15. Council for International Organizations of Medical Sciences. Available at: http://www.cioms.ch.
16. Code of Federal Regulations. 21 CFR 312.32.
17. Code of Federal Regulations. 21 CFR 314.80(f)(1).
18. Safety Reporting Requirements for Human Drug and Biological Products; Proposed Rule. 21 CFR Parts 310, 312 et al. Available at: http://www.fda.gov/cber/rules/safereport.pdf.
19. ICH Topic E 2 A. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. European Medicines Agency. CPMP/ICH/ 377/95. June 1995.
20. ICH Topic E 2 D. Post Approval Safety Data Management. European Medicines Agency. CPMP/ICH/3945/03. May 2004.
21. ICH E2C R1: Clinical Safety Data Management: Periodic Updated Safety Reports for Marketed Drugs. European Medicines Agency. CPMP/ICH/288/95. June 1997.