From July 1, 2024, the European Pharmacopoeia (EP 11.5) added "5.27 Comparability of alternative analytical procedures" (comparability of analytical methods) will be officially implemented, which provides the most direct reference basis for enterprises to develop methods. According to the new general description of European Pharmacopoeia, method substitution seems simple, but there are difficulties in practice, how to make this principle really used by enterprises? In order to solve the compliance of drug analysis methods, improve the flexibility of test method selection, and ensure the scientific establishment of methods, the pharmaceutical excipients Branch of the Medical Insurance Chamber of Commerce invited the Pharmacopoeia Method Research Center located in Hangzhou to conduct meetings and exchanges on the European Pharmacopoeia's new general theory 5.27 "Analysis Method alternative research", and invited experts in the industry to conduct analysis and discussion on the pharmacopoeia general theory.
Meeting place and time
March 25, 2024 9:00-12:00 AM
Meeting place
Biluo Hall, 4th Floor, Hilton Taizhou, Zhejiang (88 Wenxue Road, Jiaojiang District, Taizhou)
Meeting schedule
In order to better address the development and verification of drug analysis methods and regulatory compliance, this seminar will set up three discussion topics, respectively chaired by industry experts, as detailed in the schedule. Some of the guests included:
Mr. Fan Yan, Quality Director of Zhejiang Medicine and Health Products Import and Export Corporation
Dr. He Weiling, Huahai Pharmaceutical Research Institute
Mr. Feng Zhuqun, Chairman of Shijiazhuang Kareide Pharmaceutical Technology Development Co., LTD
Dr. Wenbo Li, General Manager of Huishi Consulting Hangzhou
Meeting notes
The conference is free of charge and you will take care of your own accommodation. To register, please contact the organizer:
Medical insurance chamber of commerce pharmaceutical excipients branch
Contact information: 13520848599 (wechat number is the same), Email: gxp@kcode-bj.com/xyb@cccmhpie.org.cn
Note: Due to the tight schedule, if you are willing to have a working lunch with the participating experts, please indicate when registering. Pay for your own meal.
The special invited expert guest introduced
1. Mr. Fan Yan, Quality Director of Zhejiang Pharmaceutical and Health Products Import and Export Co., LTD., has been among the top exporters of raw materials and pharmaceutical preparations in China Chamber of Commerce for Import and Export of Pharmaceutical and Health Products for many years. With nearly 2,000 foreign customers, the products are sold to more than 140 countries and regions around the world.
2. Dr. He Weiling, Ph.D., West China College of Pharmacy, Sichuan University, currently Senior Director of Quality Research Department of Pharmaceutical Research Institute of Zhejiang Huahai Pharmaceutical Co., LTD., has published more than 30 international and domestic papers, participated in a number of invention patents, led the R&D team, and was responsible for the change of standards related to pharmaceutical quality research, reference preparation application, pharmaceutical process innovation, impurity research and other technical support. He has done postdoctoral research at the University of Wyoming School of Pharmacy, Duke University Eye Center, and the University of North Carolina at Chapel Hill School of Pharmacy, and has held senior positions at several well-known pharmaceutical companies, including GlaxoSmithKline, Lonza, Hutchison, and Fesenius-kabi.
3. Mr. Feng Zhuqun, chairman of Shijiazhuang Kairide Pharmaceutical Technology Development Co., LTD., a well-known expert in international drug registration and certification, the first batch of international certification and registration experts in China, has led more than 200 domestic drug enterprises to successfully enter the European and American markets. The biggest problem, he believes, is still genotoxic impurities. Mr. Feng analyzed more than 40 drugs that will be affected in the future.
4. Dr. Wenbo Li, Founder and CEO of Hangzhou Whie Consulting. 16 years of experience in R & D, registration and certification, guiding more than 20 enterprises through FDA, EDQM, WHO GMP and PAI on-site verification; Completed more than 20 European and American DMF, CEP registration; Led more than 20 innovative drug development, clinical trials and registration applications, the establishment of R & D quality management system successfully passed CFDI verification. Led the development, clinical trials and registration of 20 generic drug conformance evaluation projects.