Clinical study of highly mutant drugs and complex preparations at the Pharmaceutical Zhi Salon-Guangzhou Drug Exchange Station (BE-validated clinical)

Introduction: September 17 guangzhou drug fair, "high-variation drugs and complex preparations of clinical research (BE-verified clinical)" drug wisdom salon invited you to meet! First, the background of the meeting: China is the world's largest producer of generic drugs, BE research and first generic drug validation clinical research is a key link in generic drug research and development, at the same time, under the background of the collection, generic drug market competition intensified, with competitive advantage of complex preparations become the focus of the current market.
be standard scientific research in China started late, is still in the stage of exploration and development.
With the concentrated evaluation of generic drug conformity 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 implementation process management need to be improved urgently; The clinical research of special drug preparations such as slow-release drugs, inhalation preparations and special injections lacks technical guidelines, as well as fast, sensitive and proprietary analytical methods and personalized statistical methods of data, and has not yet set up an independent and stable service system for scientific and perfect clinical research on difficult generic drugs.
In the current Chinese pharmaceutical innovation, complex preparations have become a hot spot for research and development 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 difficulties in technology.
development of complex preparations is not only a technical issue, but also a question of whether the supply of these drugs can be reliably guaranteed.
of complex preparations is to pursue better clinical value, better safety and effectiveness, and to address unsolved clinical needs.
in the current complex pattern of international relations, China's complex preparations are still heavily dependent on imports, which is the reason why the state encourages the development of complex preparations, including modified new drugs and generic drugs.
by high technical barriers, 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 generic drugs on the market, but still face the problem of generic drug consistency evaluation.
high-variation 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, the clinical research put forward higher requirements.
, clinical research in high-difficult generic drug research has become the norm, how to speed up the progress of research and development through top-level design? How can the risk of clinical research be reduced? How to design and implement high-level clinical trials? How do I respond to on-site verification by regulators? Are the real problems that enterprises need to solve.
In order to help enterprises break through the bottleneck of high-variation drug generics research, Nanjing LightIng 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 of high-variation drugs and complex preparations (BE-validated clinical), for you to deeply analyze the success stories, jointly explore the solution of high-variability drug BE and clinical research difficulties, ignite innovative sparks, and seek a great cause of medicine.
invite you to attend! Second, the conference overview topic: clinical research of high-variation drugs and complex preparations (BE-validated clinical) Time: September 17, 2020 13:30-18:00 Venue: Guangzhou Pharmaceutical Fair Organizer: Nanjing Lighting Medicine Technology Co. , Ltd., Pharmaceutical Intelligence Network contractor: Pharmaceutical Intelligence Media, Pharmaceutical Intelligence Elite Club meeting size: 50 people within the nature of the meeting: free participation, Wan Xie clinical CRO enterprise four, expert introduction 1, Dr. Li Zhengqi "Introduction" director pharmacist (Zheng Gao), communist party members.
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 and 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 Code (GLP), and the Drug Clinical Trial Quality Management Code (GCP).
is now a senior domestic pharmaceutical regulations and clinical pharmacy experts, national drug review experts, the industry's top GLP, GCP experts.
, 2016, founded Nanjing Lighting Pharmaceutical Technology Co., Ltd., founded to date as a legal representative, chairman and general manager.
2, Professor Jiang Hongliang is now a professor at Hua zhong University of Science and Technology, Bo Zhi, founder of Wuhan Hongliang Company.
received his Ph.D. from the University of Arizona.
has many years of experience in The Bioanalysing Division of Covance Inc. in the United States.
has hosted and participated in more than 200 pharmacodynamic and biological equivalent research projects.
has now published more than 50 papers on SCI.
is a member of the Steering Committee of the Chinese Association for Biological Analysis, a member of the Standing Committee of the Technical Branch of Drug Analysis of the Chinese Pharmaceutical Biotechnology Association, and a member of the Professional Committee of Drug Metabolism of the Chinese Pharmacological Society.
is the editorial board of the eighth edition of the people's health textbook "Drug Analysis", the youth editorial board of the Journal of Pharmacy, and the editorial board of biomedical Chromeography.
the National Science and Technology Award Review, the National Health and Planning Commission "major new drug creation" science and technology major special evaluation and the National Natural Science Foundation evaluation experts.
3, Li Tianquan, Senior Engineer, Co-Founder of Pharmaceutical Intelligence Network.
has long been 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 new drug research and development for many years, successfully developed dozens of new products.
In recent years, obsessed with the construction and utilization of pharmaceutical databases, co-founded a professional China's leading pharmaceutical big data service platform --- pharmaceutical intelligence network, specializing in the retrieval and utilization of medical information, good at reading industry policies, pharmaceutical hot information through the mining of professional data, in-depth analysis of the pharmaceutical industry development status and trends, to help enterprises make decisions.
, conference schedule six, meeting contact seven, conference registration scanning below the two-dimensional code free registration.