Research on the Group-Based Pharmacovigilance Management for Drug Marketing Authorization Holders
Objective:This study aims to provide a reference for the compliant operation of a group-based pharmacovigilance system.Methods:This research investigates the pharmacovigilance practices of representative pharmaceutical group companies and incorporates insights from pharmacovigilance inspections.It examines the construction and characteristics of group-based pharmacovigilance systems,the implementation of pharmacovigilance responsibilities,and identifies existing issues.Suggestions are provided for ensuring compliant operations within group-based pharmacovigilance systems and improving pharmacovigilance inspection practices.Results and Conclusion:Effective group-based pharmacovigilance management requires a rational division of labor and orderly connection.This approach helps maximize resource utilization,minimize risks,and enhance compliance in pharmacovigilance practices.
万方数据
维普
