Seminar on "Key Techniques for Research and Registration of Traditional Chinese Medicine Production Process Verification, Verification and Process Change"

[pharmaceutical Station conference Forum] looking at the regulatory thinking of the State Food and Drug Administration in recent years, the production process has become one of the key points of verification At present, traditional Chinese medicine enterprises lack of effective methods and approaches to the implementation and management of production process change, and there are many doubts about the application of production process change Based on the principles of science and risk control, we should adopt the modern technology in line with the characteristics of traditional Chinese medicine preparation to achieve more scientific, reasonable and stable quality change In order to summarize and exchange the process of process change in recent years, better combine the consistency of drug application process and production process, understand the doubts and difficulties encountered in the implementation of supplementary application, effectively guarantee the quality of drugs, and do a good job in self inspection and production process verification After research, our company decided to hold a seminar on "key technologies for research and registration of production process validation, verification and process change of traditional Chinese medicine" in Nanjing from August 23 to August 25, 2019 At that time, experts from relevant national competent departments and heads of relevant enterprises will be invited to discuss some hot and difficult issues in the current production process validation, on-site verification and registration change of listed traditional Chinese medicine, key technology of process change and application of modern technology We sincerely invite your representative to attend For details, please refer to the appendix: consultation method of the conference group: (click to check the contact information) contact person: Nie hang, Beijing Zhonglian Zhongke Information Management Consulting Co., Ltd (Secretariat of the conference group) July 9, 2019 I conference content and keynote experts: 1 The drafting background and key node interpretation of the guidelines for process change of listed traditional Chinese medicine; 2 How to carry out self inspection of process change and determine the nature and type of process change; 3 The detailed requirements and evaluation methods of process check and on-site verification of traditional Chinese medicine; 4 The technical requirements and routes of process change of traditional Chinese medicine 5 Key technical requirements for process validation and continuous process validation of traditional Chinese medicine; 6 Case review and key section analysis in technical guidelines for production process change of listed traditional Chinese medicine (pretreatment of traditional Chinese medicine, extraction and purification, preparation research, stability research, radiation sterilization, etc.) 7 Review on the case study and classification of the process change of toxic medicinal preparation; 8 Requirements for supplementary application of process change and key points for writing application materials; 9 Method recommendation on how to avoid clinical research in the process change of traditional Chinese medicine; 10 Process design in the process change of traditional Chinese medicine production 11 Key technology and node analysis of data collection in the process of traditional Chinese medicine production; 12 Research progress of new technology and equipment of traditional Chinese medicine production and sharing of application examples of modern technology; 2 Participants: We sincerely welcome the provincial and municipal TCM management departments, the R & D, production and quality directors or deputy general manager, chief engineer, Department Manager, production and technical management personnel, registration and application personnel, verification manager of TCM production enterprises, as well as the relevant personnel of scientific research institutes, colleges and universities 3 Time and place of the meeting: time: August 23-25, 2019 place: Nanjing City (the registration notice will be sent after the registration of the specific place) 4 Registration of the meeting: conference fee: 2500 yuan / person (including conference fee, Chinese food fee, venue fee, information fee, preparation fee, etc.), and unified arrangement fee for dinner and accommodation Preferential method: 3 member teams of the alliance will be exempted from 1 member conference fee Note: please consult the conference affairs group for promotion of sponsorship, CO organizers, corporate speeches, booths, paper covers, inserts, etc 5 Paper solicitation: this conference will collect academic reports, papers and scientific research achievements related to the theme for the whole country, and will select the best and arrange speeches at the conference Before the meeting, the printed paper collection (Key Technologies of Chinese medicine production process validation, verification and process change research registration) will be used as reference materials for the meeting Please submit the paper by August 16, 2019 Receipt form of workshop on "key technologies for validation, verification and process change research and registration of traditional Chinese medicine production process" (see download of relevant materials below)