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Pharmaceutical Company Accepts Special Inspection on Pharmacovigilance

Release time:

2020-08-17

Pharmaceutical Company Accepts Special Pharmacovigilance Inspection

News 7# On the morning of May 9 , relevant leaders of Zhejiang Adverse Drug Reaction 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 the pharmacovigilance work on the basis of checking and filling the vacancy. The relevant person in charge of

Pharmaceutical Company said that he would 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 ensure that the people use "

rest assured medicine " .

8 , the pharmaceutical company sent personnel to attend the 2020 Jinhua pharmacovigilance and risk warning seminar. during the meeting, drug marketing license holders made speeches on the difficulties and doubts in their respective work, and Lu Xiaoqin, chief of the monitoring department of Zhejiang provincial center, gave one-on-one doubts and guidance. (Fan Fangwei)

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What is Pharmacovigilance?

Pharmacovigilance is 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 the user 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 contents of pharmacovigilance include: early detection of adverse reactions of unknown drugs and their interactions; discovery of the growth trend of adverse reactions of known drugs; analysis of risk factors and possible mechanisms of adverse drug reactions; quantitative analysis of risk/

benefit evaluation, release of relevant information, promotion of drug supervision and management and guidance of clinical drug use.

The purpose of pharmacovigilance includes: evaluating the benefits, harms, effectiveness and risks of drugs to promote their safe, reasonable and effective application; preventing safety issues related to medication, improving patient safety in medication, treatment and auxiliary medical care; Educating and informing patients about drug-related safety issues, and improving public health and safety related to medication.

The ultimate goal of pharmacovigilance is the rational and safe use of drugs; risk/

benefit evaluation and communication of marketed drugs; training, education, and timely feedback of relevant information to patients.

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