Pharmaceutical Company Accepts Special Inspection on Pharmacovigilance


Release time:

2020-08-04

 7Month9On the morning of the 15th, relevant leaders of Zhejiang ADR Monitoring Center went to Jianfeng Pharmaceutical Company to carry out pharmacovigilance research, exchange and special inspection.

The inspection team conducted a detailed inspection of the personnel, institutions, individual adverse reactions and group adverse events of the pharmaceutical company, and fully affirmed the pharmacovigilance work of the pharmaceutical company. At the same time, it is hoped that the pharmaceutical company can creatively carry out pharmacovigilance work on the basis of checking and filling gaps.

The relevant person in charge of the pharmaceutical company said that it will continue to implement the main responsibility of the holder, do a good job in the management of the whole life cycle of drugs, and effectively protect the people's use of"reassurance medicine.

7Month 8On the day, the pharmaceutical company sent staff to participate.2020During the annual Jinhua City Pharmacovigilance and Risk Early Warning Seminar, drug marketing license holders made speeches on the difficulties and doubts in their respective work, and Lu Xiaoqin, Chief of the Monitoring Section of the Zhejiang Provincial Center, gave a one-on-one solution. And guidance. (Fan Fangwei)

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What is Pharmacovigilance?

Pharmacovigilance is the scientific research and activities related to the detection, evaluation, understanding and prevention of adverse reactions or any other problems that may be related to drugs. Pharmacovigilance involves not only adverse drug reactions, but also other drug-related problems, such as substandard drugs, drug treatment errors, lack of effectiveness reports, medication for indications that are not recognized without sufficient scientific basis, case reports of acute and chronic poisoning, evaluation of drug-related mortality, drug abuse and misuse, adverse interactions between drugs and chemical drugs, other drugs and food.

Pharmacovigilance starts from the safety of drug users to discover, evaluate and prevent adverse drug reactions. Require doubts to report, regardless of the quality of drugs, usage, dosage is normal or not, more attention to comprehensive analysis method to explore the causal relationship, easy to be accepted by the majority of reporters. The main work of pharmacovigilance includes: early detection of adverse reactions of unknown drugs and their interactions; discovery of the growing trend of adverse reactions of known drugs; analysis of risk factors and possible mechanisms of adverse drug reactions; analysis of risk/Quantitative analysis of benefit evaluation, release relevant information, promote drug supervision and management and guide clinical drug use.

The purpose of pharmacovigilance includes: to evaluate the benefits, harms, effectiveness and risks of drugs to promote their safe, reasonable and effective application; to prevent safety issues related to drug use, to improve the safety of patients in drug use, treatment and auxiliary medical care; to educate and inform patients of drug-related safety issues, and to promote public health and safety related to drug use.

The ultimate goal of pharmacovigilance is the rational and safe use of drugs/Benefit evaluation and communication; training and education for patients, and timely feedback of relevant information.