Training on the First Responsible Person System of Pharmaceutical Production Enterprises

On January 29, 2018, the National Adverse Reaction Monitoring Center held the "Training Course on the Implementation of the First Responsible Person System for Drug Manufacturers" in Nanning, Guangxi. Our full-time drug risk management staff also participated in this study and training.

The main contents of this study and training include 13 items, including the system for direct reporting of adverse reactions by drug marketing license holders, introduction and planning of direct reporting system for adverse reactions, basic information and requirements of ICH, pharmacovigilance plan, risk assessment report, guidelines for collection and reporting of individual adverse drug reactions, discovery and evaluation of drug risk signals, discovery and risk control of aggregation signals of adverse drug events, analysis of adverse drug reaction reports and monitoring and inspection points, etc..

This round of training and learning was sponsored by the National Adverse Drug Reaction Monitoring Center and undertaken by the Guangxi Adverse Drug Reaction Monitoring Center. About 300 drug manufacturers and more than 500 people participated.