Study of Guideline for Drug Man ufacturer on Adverse Drug Reaction Reporting and Monitoring with Delphi Method

Abstract

Abstract: Objective To build up Guideline for drug manufacturer on adverse drug reaction reporting and monitoring. Methods Using the Delphi method, experts were consulted in two rounds to confirm 15 critical items in the Guideline. Results The response rates of the two investigations were all 100% . The authority means of the two rounds were .86 and 0.87 respectively. 12 critical items are reached 75% concentration of expert consultations. Conclusion The enthusiasm and authority of the experts were good. An initial Guideline for drug manufacturer on adverse drug reaction reporting and monitoring has been set up.

Key words: Delphi method, drug manufacturer, adverse drug reaction reporting and monitoring, guideline

CLC Number:

R951

DONG Duo, SUN Li-hua. Study of Guideline for Drug Man ufacturer on Adverse Drug Reaction Reporting and Monitoring with Delphi Method [J]. Chinese Journal of Pharmacovigilance, 2013, 10(9): 523-526.

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