First, the series setting?
If you are a newcomer, you must want to know what kind of job registration is. In the previous discussion, we temporarily positioned the registered personnel as four levels, namely: primary, intermediate, advanced and super. ?
? Junior year (P level)?
At this level, the most downstream is basically? Run? To register, first copy the binding materials, and then go back and forth to find relevant departments and institutions. Through study, gradually deepen the understanding of laws and regulations. ?
Then, I am familiar with the chapters on registration procedures and requirements in the Basic Law "Measures for the Administration of Drug Registration"; Understand the significance of monitoring period, transition period, new drug protection period, administrative protection of traditional Chinese medicine, administrative protection and patent protection; Can legally analyze whether a drug can be reported, according to several categories, what certification documents and application materials are needed; Which data should be tested and which can be replaced by literature; Which can be exempted from clinical practice and which must be bioequivalent; Will write some documents and review materials. This is the transition from manual labor to mental labor.
However, we must not stay at this stage for a long time. What is the work at this stage? Secretary? +? Salesman? . Writing materials can't be graded and published; On running errands, it is better to make money by marketing; Knowing laws and regulations, but not knowing why, there is often a rigid understanding (seeing mountains as mountains and water as water); No, no, no,no. It's embarrassing.
? Second intermediate level (M level)?
At this level, the ability is higher than the primary level, because labor needs intelligence more. ?
Basically, the registered project personnel at this stage should be from scientific research or production. Will think about problems from the perspective of R&D and production, and understand the experimental operation; Familiar with the industry market, able to predict the prospects of products.
Intermediate, we should not only consider legal restrictions, but also evaluate the test, production difficulty and risk of this variety; Accumulated considerable resources, good at querying literature, collecting needed information efficiently and quickly, and making analysis and judgment; Be able to master review principles and technical requirements, and check technical problems in experimental design; Can be very sensitive to find technical errors in the application data (such as whether the enhanced destruction test is reasonable, whether the separation degree, baseline, tailing and set range of the atlas meet the requirements), and can see whether there are errors in the methodology design (such as whether the orthogonal test design is reasonable, whether there is a blank, whether the animal model of pharmacological test is reasonable, whether it is consistent with the functional indications or indications, whether the toxicological indicators and organs meet the requirements, and whether the statistics are reasonable). ), and have the ability to judge the test results and conclusions (such as whether the orthogonal test design is reasonable, whether there are gaps, whether?
Intermediaries can understand the regulations and technical requirements from the perspective of scientific research, guide research and development, and conduct technical checks on the application materials. At this stage, register? And then what? Research and development? And then what? Production? The boundary between the two is gradually blurred, and its technical core can be seen through the provisions of laws and regulations; Through the evaluation principle, what we see is theoretical analysis (looking at mountains is not mountains, looking at water is not water). Only in this way can we deepen the professionalism of the registration project.
? Three advanced (S level)?
At this level, people are better, and they can get a panoramic view of the key points and defects of laws and regulations at a glance; These cattle people may not have good experimental operation skills, but they can think strategically and point to the lifeblood of research and development; With knowledge as capital, advance and retreat are full of romance.
For example, if you are proficient in patent writing or destruction at the same time, you can advance or retreat if you think about it; Good at studying global patented drugs, closely tracking the global new drug trends, and exploring opportunities for me to copy and register; Focus on foreign countries, concentrate on investment planning, and focus on the establishment of new drugs (real new drugs, not so-called improved dosage forms); Familiar with domestic and foreign laws and regulations, know how to exploit the loopholes of laws and regulations; Familiar with the whole process of drug research and development, declaration, production and sales, with deep connections. ?
At this level, regulations and technical requirements are not the focus. At first glance, the regulations are clean, leaving no dross (so-called mountain or mountain, water or water). This is the advanced stage of registration. Four special grades (X grade)
This so-called? Special? Class, right? Special? what's up Special? , is it? China characteristics? what's up Special? . Which means those. Can do great things? It becomes impossible for possible wizards.
For example, it takes two years for a drug to be certified according to normal procedures, and it takes several months for a grandmaster to get it; When several families compete for the first batch, they ask the grandmaster for help, so that they can be slow first and then fast, first come and then arrive; Some drugs that obviously do not meet the registration requirements can also be brought back to life. It's amazing. ?
Unfortunately, however, what about these? Super? None of the masters practice light spells, but they are all dark people who can't see the light. Especially in the current environment, whether you can protect yourself is questionable. so this is it？ Super? Failure to follow the rules of the game ruined the industry. ?
? It can be seen that, on the one hand, the present scenery is no longer, on the other hand, it is super and gentleman.
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