Pharmacy Salon-Chengdu Station Clinical Study of HighLy Variant Drugs and Complex Preparations (BE-Verified Clinical)

Guide: August 28, 2020 Pharmacy Salon - Chengdu Station is not with you.
. Background China is the world's largest producer of generic drugs, BE research and the first generic validation clinical research is a key link in generic research and development, at the same time, under the background of collection, the market competition in generic drugs intensified, with competitive advantage of complex preparations become the focus of the current market.
be standardized scientific research in China started late, is still in the stage of exploration and development.
With the concentrated evaluation of generic drug consistency in China, the short boards in the field of BE research technology and supervision are gradually emerging: the scientific design of BE clinical trial program in China needs to be improved, the quality system and the management of execution process need to be improved urgently; Clinical research on special drug preparations such as controlled release preparation drugs, inhalation preparations and special injections lacks technical guidelines, as well as rapid, sensitive and exclusive analytical methods and personalized statistical methods;
In the current Chinese pharmaceutical innovation, complex preparations have become research and development hotspots because of their obvious clinical value, good safety and long product life cycle, but at the same time, whether it is improved new drugs or generic drugs, there are technical difficulties.
development of complex preparations is not only a technical issue, but also a question of whether the availability of these drugs can be reliably guaranteed.
complex preparations are developed to pursue better clinical value, better safety and effectiveness, and to address unfinished clinical needs.
in the current complex pattern of international relations, China's complex preparations are still heavily dependent on imports, which is the basis for the State to encourage the development of complex preparations, including improved new drugs and generics.
by high technical barriers, original research patent protection, key accessories and equipment constraints and other factors, even in Europe, the United States and Japan and other countries approved complex preparations of generic drugs are very limited.
, although there are very few complex preparations generic drugs listed in China, but still face the problem of generic drug consistency evaluation.
high-variant drugs are a kind of BE research difficult varieties, the research and development cycle is longer, the investment is larger, the research and development risk is also higher, put forward higher requirements for clinical research.
, clinical research in highly difficult drug-like research has become the norm, how to speed up the progress of research and development through top-level design? How to reduce the risk of clinical research? How to design and implement high-level clinical trial scenarios? How should regulators respond to on-site verification? Are the real problems that enterprises need to solve.
To help enterprises break through the bottleneck of highly variant drug generic research, Nanjing Light Pharmaceutical Technology Co., Ltd., Chongqing Dinali Pharmaceutical Technology Co., Ltd., Pharmaceutical Intelligence Network invited domestic first-line clinical and pharmaceutical experts, held a nationwide clinical research salon for high-variant drugs and complex preparations (BE-verified clinical), for you to deeply analyze the success of the case, jointly explore solutions to the difficulties of highly varied drug BE and clinical research, ignite the spark of innovation, and seek great medicine.
invite you to attend! Second, conference overview topic: clinical research on highly variant drugs and complex preparations (BE-verified clinical) Time: August 28, 2020 13:30-18:00 Location: Chengdu Hilton Hotel Taurus Hall 2nd Floor (Chengdu Tianfu Avenue, 6th floor) 66th) Organizers: Nanjing Light Pharmaceutical Technology Co., Ltd., Chongqing Dinali Pharmaceutical Technology Co., Ltd., Pharmaceutical Intelligence Network Contractor: The size of the pharmaceutical and intellectual media conference: 50 people within the nature of the meeting: free participation in the four, expert introduction 1, Dr. Li Zhengqi (introduction) Director pharmacist (Zheng Gao), members of the Communist Party of China.
has been engaged in pharmaceutical research and management since graduating from the Second Military Medical University in 1987.
In 2000, he was transferred to the Director of the Drug Certification Management Center of the State Drug Administration, mainly engaged in the technical and organizational management of on-site inspections such as the Drug Management Practice (GSP), the Drug Non-Clinical Research Quality Management Practice (GLP), and the Drug Clinical Trial Quality Management Standard (GCP).
is now the domestic senior pharmaceutical regulations and clinical pharmacy experts, national drug review experts, the industry's top GLP, GCP experts.
, 2016, founded Nanjing Light Pharmaceutical Technology Co., Ltd., founded to date as the legal representative, chairman and general manager. dr.
2,Yuhuan: Laboratory Director, Dineley Pharmaceutical Technology Co., Ltd., Chongqing; Ph.D., University of Boston, USA; Former Chief Bioanalysis Scientist, Nova BioAssays, Boston, USA; Bioanalysis of liposuction, proteins, nucleic acids and polysaccharides and biomarkers.
led the Dinali team to successfully develop, validate and sample test a number of liposuction drugs.
3, Li Tianquan, senior engineer, co-founder of Medicinal Intelligence Network.
long-term engaged in research and development in the pharmaceutical industry, undertake a number of national and provincial research and development projects, access to national invention patents 5, as the head of research and development of new drugs for many years, the successful development of dozens of new products.
In recent years, indulging in the construction and utilization of pharmaceutical database, co-founded a professional China's leading pharmaceutical big data service platform--- pharmaceutical intelligence network, specializing in the retrieval and utilization of pharmaceutical information, good at through professional data mining to interpret industry policies, pharmaceutical hot information, in-depth analysis of the pharmaceutical industry development status quo and trends, to help enterprises make decisions.
, meeting schedule six, meeting contact seven, meeting registration scan below the two-dimensional code can be registered to participate.