2018 pharmaceutical intelligence data national tour Chongqing station is about to open

Interpretation of drug registration laws and regulations and implementation of ectd release and 2018 national tour of drug intelligence data Chongqing station time: June 1, 2018 (Friday 8:00-17:00) location: Chongqing 2018 drug intelligence data will hold 10 tour lectures in China, so far, 5 tour lectures have been held in Beijing, Guang'an, Guangzhou, Shanghai and Hangzhou, which are unanimously welcomed and praised by people in the pharmaceutical industry In early June, we will open a round of high-end closed door training meeting in Chongqing, a beautiful mountain city, with the theme of "interpretation of drug registration laws and regulations and practice of ectd release" 1、 Recently, the review center of the State Food and Drug Administration issued the 2017 annual drug review report The sixth chapter "key work arrangement in 2018" clearly states that ".. Continue to promote the establishment of the ectd system for registration application acceptance, data collection, evaluation, review report formation and review process management, and realize the electronic application and review of chemical generic drugs as soon as possible in accordance with the requirements of the ectd." As a general technical document standard, ectd is widely used in the global pharmaceutical industry, which can significantly improve the efficiency of document creation and review Since January 1, 2018, the European Union has mandated the application of ectd for APIs, and the United States has mandated the use of ectd for APIs on May 5, 2018 Submissions of other formats will be rejected At the same time, in order to adapt to the booming trend of the pharmaceutical industry, help major pharmaceutical enterprises to control the new regulatory requirements, get familiar with the ectd declaration specifications as soon as possible, understand the basic knowledge of ectd declaration, and combine with the local industrialization policies of Chongqing, Suzhou corite Information Technology Co., Ltd jointly held the high-end operation of 2018 Chongqing station drug registration regulations and ectd release jointly with the pharmaceutical intelligence network on June 1, 2018 Closed door training meeting, we sincerely invite the registered specialists of all units to communicate with each other to meet the needs of the times At that time, hundreds of excellent pharmaceutical enterprises will gather together Suzhou corite provides a unique one-stop learning platform for biopharmaceutical companies, new drug R & D enterprises and professionals to help improve the quality of drug application and keep pace with the international advanced level Are you ready for the era of ectd electronic delivery? 2、 Keynote speaker 1 Co founder of Yihui Suzhou kerit Information Technology Co., Ltd and principal of ectd software development [introduction] he was once in Renfu pharmaceutical and Beijing kanglihua With years of domestic and foreign experience, he has accumulated a lot of practical project experience, and is responsible for the registration of preparations, APIs, excipients and packaging materials in many countries and regions, including domestic generic drugs, TGA supplementary drugs, DMF and ASMF He has rich experience in registration and application, and is familiar with the whole process of drug registration and application Main topics: Interpretation of drug registration regulations and practice of ectd release 2 Li Tianquan, co-founder of drug intelligence network, President of drug intelligence elite club, senior engineer [introduction] he has been engaged in the research and development of the pharmaceutical industry for a long time, undertaken a number of national and provincial research and development projects, obtained 5 national invention patents, served as the director of new drug research and development for many years, and successfully developed dozens of new products In recent years, he has been absorbed in the construction and utilization of medical database, and jointly established a professional China's leading medical big data service platform, yaozhi.com, which specializes in the retrieval and utilization of medical information He is good at interpreting industrial policies and hot medical information through the mining of professional data, deeply analyzing the development status and trend of the pharmaceutical industry, and helping enterprises make decisions Main topics: research and development trends and analysis of drugs under the new regulatory system 3 Huang Wenfeng, director of marketing department of pharmaceutical intelligence network, senior lecturer of pharmaceutical Intelligence College [introduction] graduated from Huazhong University of science and technology in 2008 with a master's degree and joined the pharmaceutical intelligence network in 2018 He used to work in Shanghai pharmaceutical, Chongqing Laimei, Wanquan pharmaceutical holding and other well-known domestic listed enterprises During this period, he served as the director of the synthesis department and the project manager Familiar with pharmaceutical laws and regulations, pharmaceutical information retrieval and utilization, patent analysis, route development and design, process optimization, quality research and control, medium test certificate and production implementation, registration document preparation So far, 18 pilot projects, 10 pilot projects and 10 production projects have been completed under guidance, of which 6 API products have been put on the market (including sterile API) A total of 17 Chinese invention patents (11 for the first inventor and 5 for the second inventor) have been applied for So far, 7 patents have been authorized Main topics: drug registration information retrieval and utilization 4 Chen scientific research, general manager of Suzhou kerit Information Technology Co., Ltd main topics: development and response strategies of ectd in the world 3 Highlights of Chongqing station conference 1 The seminar gathered representatives of domestic high-quality pharmaceutical enterprises and leaders of pharmaceutical enterprises, and was recognized by experts / leading enterprises in the pharmaceutical industry 2 Combining theory with practical operation demonstration, we will carry out all-round science popularization and analysis of the development trend and the reform of drug registration and declaration in ectd, from abstract to concrete, and share with industry experts 3 10 lucky visitors will be selected from the seminar site, and the lucky visitors can get a beautiful gift from corite 4、 Chongqing station conference process 5 Chongqing station venue address: Chongqing Vienna International Hotel Address: no.215-3, Baosheng Avenue, Yubei District, Chongqing 6 Chongqing station registration method 1 He Jiao, database consultant of Chongqing Kangzhou big data Co., Ltd (Yaozhi network), Tel.: 15902343914 wechat: 15902343914 2 Manager Yang, Suzhou corite Information Technology Co., Ltd Tel: 18512557561 wechat: 18512557561 7 The organizer Chongqing Kangzhou big data Co., Ltd (yaozhi.com) Suzhou kerit Information Technology Co., Ltd 8 The form of participation includes lunch (about 80 people) for free In early June, we met Chongqing, with more content and more harvest We are looking forward to meeting you! The basic information of the meeting is introduced here If you want to learn more, please pay attention to our website.