I copied it! hehe! I am also a pharmacy student. I graduated in June this year. After working for a while, I plan to prepare for the postgraduate entrance examination. The question of whether to take the postgraduate entrance examination depends on what you think. Don't be affected by other people's thoughts and believe in your own choice. Educational qualifications and skills. Academic qualifications are still useful, it is a stepping stone, but skills are the foundation, so try to learn in practice. I have seen many bosses today who did not go to high school.
As for the drug registration specialist, I copied it. I hope it is useful to you.
From the perspective of the pharmaceutical administration authority, drug registration refers to the State Food and Drug Administration’s review of the safety, effectiveness, and safety of drugs to be marketed in accordance with legal procedures based on the application of the drug registration applicant. The quality controllability, etc. will be reviewed and the approval process will be decided whether to agree with the application. ”
From a corporate perspective, from pre-project research to obtaining marketing authorization, to post-market commitment research and supplementary applications, the participation of drug registration personnel runs through the entire life cycle of the product. Registration. In addition to organizing materials and tracking review progress in accordance with the format requirements of the pharmaceutical administration authorities, personnel also need to understand relevant laws and regulations, guiding principles, review technical requirements, various electronic journals and related literature of the pharmaceutical administration authorities, and have CMC, pharmacology and Knowledge of toxicology, clinical trials, trademarks, patents, and even marketing, familiarity with the drug development and review process, and mastery of communication skills with the drug administration and various departments within the company. High-level registration personnel also need to consider the overall situation. Think strategically: “How does this impact registration, and how does it impact other departments? What can I do by registering? What are the risks and benefits of doing this? Are these risks and benefits temporary or long-term? What are the consequences of not doing this? …”Higher-level registrants will have higher-level exchanges with the drug administration authorities, such as the latest trends from the FDA and EMA, introductions to the advanced R&D technologies of multinational companies, and feedback on some drafts of the drug administration authorities.
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