On the afternoon of July 18th, the "Drug Safety Watch and Help" book donation activity jointly organized by the Drug Safety Cooperation Alliance, chemical industry publishing house and Beijing Jingshi Law Firm was successfully held in the chemical industry publishing house. Bai Huiliang, Honorary Chairman of the Drug Safety Cooperation Alliance, Pan Guangcheng, Executive President of the Chemical and Pharmaceutical Industry Association, Li Xinling, Director of the Drug Evaluation Center of the State Drug Administration, Ji Xiangde, Doctoral Supervisor of the Chinese Academy of Social Sciences, Zhang Yaohua, President of the RDPAC Kangwei Chinese Pharmacist Association, Wu Zhaohui, Vice President of the China Pharmaceutical Biotechnology Association, Chen Xianxia, Vice President of the China Pharmaceutical Packaging Association, Cao Liya, Vice President of the China Toxicological Association, Wang Ao, Secretary General of the China Over-the-Counter Drug Association, Tang Qin, Director of the Science Popularization Department of the Chinese Medical Association, Zhang Lei of China Pharmaceutical Association, Wang Guihua, Secretary General of China Association of Chinese Medicines, He Qiurong, Vice President of China Pharmaceutical News and Information Association, Xie Yijiong, Deputy Secretary-General of China Pharmaceutical Commerce Association, Gao Yonghua, Secretary-General of China Pharmaceutical Packaging Association, Zhang Mingyue, Deputy Secretary-General of Beijing Pharmaceutical Industry Association, Zhang Wenhu, Secretary-General of Pharmaceutical Safety Cooperation Alliance, Zhu Fei, Assistant Chairman of Drug Safety Cooperation Alliance, Xue Yanghui, Assistant Secretary-General of Drug Safety Cooperation Alliance, Dai Xinmin, Chairman of Huashi Pharmaceutical, Geng Wenjun, Senior Vice President of Chia Tai Tianqing, Ma Yiqiang, Deputy General Manager of Market Access of Jirui Pharmaceutical (China) Co., Ltd., Tong Jiahui, Government Affairs Manager of Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Chen Yuying, Government Affairs Manager of Shanghai Johnson & Johnson Pharmaceutical Co., Ltd., Wang De, Editor-in-Chief of China Medical Humanities Magazine, Sheng Long, Legal Director of All-Union Pharmaceutical Chamber of Commerce, Zhou Jian, Vice President of CMC of Thinkdia Pharmaceutical, Diana He, CIO of Fahrenheit Pharmaceutical, Sharihar Schaensby, Deputy General Representative of China General Technology Group Abroad, Ge Zhimin of China National Pharmaceutical Group, Yu Jiyun, Chairman of Aurora Dingtai Biologics, Cui Qiuhua, General Manager of Maiso Chemical, Zuo Wei, General Manager of Weizhi Pharmaceutical, Zhang Long, Manager of Daxing Pharmaceutical Valley, Meng Lei, General Manager of Beijing Tongzhou Industrial Development Zone Corporation, and other guest leaders attended the event. Secretary General Zhang Wenhu presided over the ceremony.
Secretary General Zhang Wenhu presided over the ceremony. At the beginning of the meeting, President Pan Guangcheng delivered an opening speech. He pointed out that pharmaceutical companies need to have a sound compliance management system in the process of operation. Taking the drug supervision system as the general outline and the whole life cycle of pharmaceutical enterprise development as the main line, the "Open Course on Legal Practice of Pharmaceutical Enterprises" systematically sorts out the regulatory system in the pharmaceutical field, the establishment and approval procedures of different types of pharmaceutical enterprises, the compliance issues and legal risk prevention of pharmaceutical enterprises, intellectual property protection, the design of the equity structure of start-up companies, and other legal issues closely related to the production and operation of pharmaceutical enterprises, and presents the research results on the compliance issues of pharmaceutical enterprises in the new stage.
Editor-in-Chief Dai Huiyu introduced the book publishing process. She said that based on its many years of legal practice experience in the field of medicine and health, the legal team of Jingshi Pharmaceutical and Life Sciences spent a year compiling and publishing the book "Open Course on Legal Affairs of Pharmaceutical Enterprises". According to the characteristics, priorities and key points of the development of pharmaceutical enterprises, and combined with the pain points and difficulties faced by enterprises in the process of practice, this book provides professional legal practice operation services for pharmaceutical enterprises and helps pharmaceutical enterprises further optimize the industrial structure.
Professor Ji Xiangde believes that under the background of the strategic goal of "Healthy China", the pharmaceutical industry has profound development prospects and needs the legal services and support of professional teams serving the field of medicine and health, such as the team of lawyers Dai Huiyu of Jingshi. In the face of the new policy and international environment, how to strengthen the self-construction of pharmaceutical enterprises, improve compliance management, continuously adapt to the requirements of the new development environment, and achieve continuous breakthrough innovation is the core and key that pharmaceutical enterprises should pay attention to.
Vice President Geng Wenjun pointed out that on the basis of interpreting professional theories, the Open Course on Legal Practice of Pharmaceutical Enterprises integrates a specific analysis of practical cases, and summarizes the systematic response system by sorting out various key issues that may be faced in the development process of pharmaceutical enterprises and the interpretation of relevant legal provisions, providing a systematic reference model for pharmaceutical enterprises and their managers.
Chairman Dai Xinmin stressed that the book "Open Course on Legal Practice of Pharmaceutical Enterprises" closely combines policy development, takes equity structure, capital operation, compliance management and property rights protection as the starting point, and further optimizes the enterprise management structure, prevents market risks, promotes the coordinated development of enterprises and industries, realizes the two-way take-off of economic interests and social benefits, and helps and promotes the development of China's health and health undertakings on the basis of providing professional legal practice operation services for pharmaceutical enterprises.
Subsequently, Li Xinling, director of the Drug Evaluation Center of the State Drug Administration, made an in-depth interpretation of the "Pharmacovigilance Quality Management Practice". He pointed out that the "Pharmacovigilance Quality Management Specification" (hereinafter referred to as the "Specification") issued by the State Drug Administration in May this year is the first relevant supporting document issued by the State Drug Administration Department since the Drug Administration Law of the People's Republic of China stipulates that China establishes a pharmacovigilance system. Under the background that the "Norms" will be formally implemented, enterprises should actively make preparations for the implementation of the "Norms", establish and continuously improve the pharmacovigilance system as required, standardize the pharmacovigilance activities, conscientiously fulfill legal obligations, coordinate relevant units and social forces, and actively participate in the process of comprehensively building China's pharmacovigilance system to jointly escort human health.
Finally, the Chemical Pharmaceutical Association, the Pharmaceutical Enterprise Management Association, the China Eugenics and Eugenics Association, the Chinese Medical Doctor Association, the Tongzhou Industrial Development Zone Corporation and other units accepted the donation of the new book and took a group photo.
Source: Orient Net