Xingwanhui & ICH Salon Issue 8|Offline learning activities of the ICH Guiding Principles Implementation Presentation Conference
Author:GrandBay BioDate:2021-04-29From:GrandBay Bio

On the afternoon of April 28, with the support and guidance of Pingshan District Science and Technology Innovation Bureau, the eighth issue of “Xingwan Huihui” was organized by Shenzhen Xingwan Biomedical Development Consulting Co., Ltd. and co-organized by Shenzhen Pingshan High-level Talents Association. & ICH Salon Activities' ICH Guiding Principles Implementation Promotion Conference Offline Learning Activities" were carried out smoothly. This event was carried out by a combination of online video live broadcast and offline communication and learning, to jointly learn ICH guidelines and discuss how to improve the quality of medicines in line with international requirements. Nearly 20 representatives of biopharmaceutical companies, including Wanle Pharmaceutical, Yourui Biotech, Raffles Pharmaceuticals, Aixindawei Pharmaceutical, Haobang Pharmaceutical, Jianyi Biotechnology, and Southern University of Science and Technology Pingshan Biomedical Research Institute, were invited to participate in this conference. Events.


First of all, Wen Baoshu, Director of the Quality Management Office of the ICH Office of the State Drug Administration and the Center for Drug Evaluation, mentioned in the introduction of the progress of China's ICH work that since the State Drug Administration joined the ICH in 2017, 46 ICHs have been transformed and implemented. As a guiding principle, 69 experts were sent to 36 topics. Five years of efforts have made China's drug regulatory concepts more scientific, legal and regulatory systems more mature and complete, technical standards systems more systematic and complete, review and approval more standardized and efficient, and the level of internationalization and modernization of supervision continues to improve. It also means that China's drug regulatory agencies, pharmaceutical industry, and R&D institutions are gradually transforming and gradually implementing the highest international technical standards and guidelines.



  Subsequently, the leaders of each department of the Drug Approval Center gave a detailed explanation of the overview, use strategy, implementation and impact of the four series of guiding principles of ICH Q, M, S, and E. Among them, Wang Jun, deputy director of the Department of Statistics and Clinical Pharmacology of the Center for Drug Evaluation, mentioned that the National Bureau issued an announcement on the application of E9(R1) on January 21, 2021. The announcement clearly stated that 12 months from the date of issuance E9 (R1) is applicable to the drug clinical research initiated. It is hoped that the pharmaceutical field will learn in advance and attract attention. This is also the purpose of this seminar.


Representatives of biopharmaceutical companies earnestly studied the two-and-a-half-hour live broadcast. After the meeting, they discussed the common issues of pharmaceutical companies such as the current drugs developed by the company, the current status of China's generic drugs, how to develop new drug research and development, and how to make technological improvements. A lively discussion. Wu Ziqiang, director of the Technology Center of Wanle Pharmaceutical, shared: "The drug R&D capabilities of Wanle Pharmaceutical are also in continuous progress. The content in the ICH guidelines is of great guiding value for our technological improvement, and will be repeated as a sunflower treasure. Thank you very much to the organizer for organizing Pingshan Pharmaceutical Enterprises to study together, and hope to work hand in hand with everyone."


The "Xingwan Hui & ICH Salon" series of activities are under the guidance of Pingshan Science and Technology Innovation Bureau and created by Xingwan Biopharmaceutical Company. Research and development of innovative drugs of international quality under the ICH environment. At the same time, it attracts incremental enterprises with international innovative drug development and market competitiveness to enter the park for development, and finally form the brand of Shenzhen Pingshan ICH Park.

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