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Master the common sense of emergency management, improve quality management practices

Drugs are a special kind of commodity, and drug safety has increasingly become a global event. The supervision of the national drug regulatory authorities is increasing. Under the general authority of the “four most severe” pressures, the general manager of the drug is in charge of drug manufacturers. The common sense of drug safety emergency management has become an important part of improving quality management regulations. How to do a good job in drug safety emergency management, the key to do the following aspects:

First, the importance of drug emergency management

Drug safety emergency management is an important part of the quality management standardization work. It can improve the quality management standard of the enterprise, and reduce the risk of sudden disaster events once a safety incident occurs.

Second, grasp the basic principles of drug safety emergency management

The drug safety emergency management work is based on prevention, and often adheres to the principle of unremitting, insists on building a unified leadership, division of labor, unified command, standardizing the process system, formulating drug safety emergency plans, and strengthening drug safety emergency response capabilities.

Third, consolidate the basic work of drug safety emergency management

1. The company established a drug emergency management leading group, equipped with full-time and part-time personnel to carry out emergency management work, and strengthened the construction of emergency teams, equipment and emergency work plan systems, and carried out necessary emergency drills. The purpose is to reduce the hazards of emergencies in the process of responding to emergencies, to achieve optimal decision-making, and to effectively warn, control and deal with emergencies.

2. Do exercises around the content of drug emergency management, such as: accident analysis, prediction and early warning, resource planning, organization, deployment, post-processing of events, coordination of emergency system and external relations.

3. Take the responsibility of the main body of drug safety, ensure that the quality management system can really play its role, and strictly implement national standards and industry standards.

4. Grasp the risks in a timely manner, effectively prevent risks and properly cope with risks. The drug strengthens the risk management after listing, and earnestly performs product quality tracking and bad product monitoring.

5. Relying on informationization, giving full play to the advantages of big data and improving the level of risk monitoring.

Fourth, master the drug emergency response skills

1. Effectively and calmly respond: quick response, start the plan, fully rely on; actively prepare, grasp the truth, have a bottom in mind, unify the caliber, grasp the opportunity.

2. Seek truth and be pragmatic; seek truth from facts, adhere to principles, do things on the matter, do not involve others, make fewer comments, and carefully conclude.

3, I only choose to declare: not unbiased, favorable choices, concise and concise, more words will be lost.

4, set the terms of the rules: such as the "three sentences" method, bridge transition method, banner advertised law.

(1) The “Three-Sentences” Act: a brief passage of things; the main reason for identification; the measures we are taking (already already being).

(2) Bridge transition method: Avoid heavy weight and transfer topics.

Such as: "From another angle..." "When I talk about it, I think you must know..." "This is very important, but it is equally important..."; "Before talking about other topics, I I want to add..."; "I am not an expert in this area, but what I want to say is..."; "Your question is unique, but I want you to know...".

(3) Banner slogan: Take the arguments put forward by us as arguments, and tell the arguments that are beneficial to our facts, in order to fully prove that our views are correct.