The 37th issue of freehand brushwork forum held in Beijing

Introduction: on the morning of May 30, the 37th issue of the two-day freehand brushwork Forum opened in Beijing The event attracted more than 400 drug registration managers from all over the country to participate in the meeting The big guys such as Chunna, Zhou Lichun, Li Huifen, and the publisher of dandelion Pharmaceutical Technology Forum "Xiaoyao" made brilliant speeches There were no empty seats and heated discussions The 37th session of the event was held at the 37th session of the event The leaders from the pharmaceutical industry, such as enterprises, government departments and the Internet, made speeches and shared on the topic of "the road of excellent drug registration manager" What is a good drug registration application data comes from Zhou Lichun, assistant director of Beijing Institute of drug control, who made a keynote speech "follow the road and get the road: to achieve a good drug registration application data" When answering this question, Zhou Lichun thought that we should achieve four points: authenticity, purpose, logic and integrity The basic work of drug registration application materials starts from the original record, which is the basis of application materials and the basis of application materials So the authenticity, standardization and integrity of records are very important So what is a good original record? Zhou Lichun quoted an expert as saying: "no matter when I read the record, I can know how I thought and how to operate." Li Huifen, a drug review expert from the State Food and drug administration, made a keynote speech entitled "I have done on-site verification of drug registration in these years" Li Huifen started from the abnormal number of applications in 1998, the large-scale verification of original materials in 1999, and the revision of the new drug evaluation method in 1999 due to the confusion until the introduction of the key points and judgment standards for on-site verification of drug registration in 2007 He described the past and present life of the drug registration management regulations It can be said that the regulations were developed and improved in a game She believes that: new drug research and design is a multi-disciplinary and multi-step work, which is a very complex system engineering, which determines the complexity of drug registration on-site verification What does the enterprise want our drug registrants to do comes from "Xiaoyao", the moderator of dandelion Pharmaceutical Technology Forum, and Xia Yun, the director of project management department of antibody drug research institute of Shanghai Hengrui Pharmaceutical Co., Ltd., who has done "experience sharing of domestic clinical application of biological products" Xia Jun shared her personal experience in clinical application of biological products in China She thought: "when enterprises want to register, the opinions we put forward are that registration is a part of the whole project, it is not all, but it is a very important part So let the enterprise know what our drug registrants do Then the personnel in the enterprise should be familiar with the company, and have a sufficient understanding of the laws and regulations, and do a good job in risk early warning " Wu Xiaoming, deputy general manager of Anhui Xianfeng Pharmaceutical Co., Ltd., made a keynote speech entitled "drug R & D and" quality " Wu Xiaoming described the skills needed to be mastered in drug quality management and R & D registration application from three aspects: being a good tailor in the field of drug R & D, R & D opportunities and quality in the eyes of the registrant He thought: "as a R & D personnel, different from the production personnel, it is necessary to have a thorough understanding of the product, analyze from what perspective, what is the impurity generated, whether the impurity is a process impurity or a known impurity, or a degradation impurity If we are to reduce the impurity, what is the degradation way." This is the value of R & D personnel, so drug registration R & D personnel can take it all in any industry " At the meeting, Chunna, the director of laws and regulations and registration department of LVYE Pharmaceutical Group Co., Ltd., Du Tao, the general manager of Beijing Hans wisdom Pharmaceutical Development Co., Ltd., Deng Wanhe, the registered manager of Novartis, Zhang Yufeng, the founder of Xianda data, Ding Xiangyuan new drug moderator "immortal bird", and Kang Cailian, the general manager of Medicine Department of Hongshang group made keynote speeches respectively The intellectual property rights of the above articles belong to yaozhi.com If you need to reprint, please indicate the source and the link of this article.