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    Home > Medical News > Latest Medical News > Pharmaceutical wisdom salon Chengdu station successfully held! Explore the path of high-variation drugs and complex preparations!

    Pharmaceutical wisdom salon Chengdu station successfully held! Explore the path of high-variation drugs and complex preparations!

    • Last Update: 2020-09-25
    • Source: Internet
    • Author: User
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    Guide: Complex preparations become the focus of the market.
    . At present, complex preparations have become a hot spot in 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 high technical barriers, patent protection of original research, key accessories and equipment constraints and other issues.
    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.
    we accelerate research and development with top-level design? How can the risk of clinical research be reduced? How do I respond to on-site verification by regulators? August 28, by Nanjing LightIng Pharmaceutical Technology Co., Ltd., Chongqing Dinali Pharmaceutical Technology Co., Ltd., Pharmaceutical Intelligence Network co-sponsored by Pharmaceutical Intelligence Media hosted the Pharmaceutical Science Salon, held in Chengdu Hilton Hotel as scheduled.
    This issue, with the theme of "Clinical Research of High-Variation Drugs and Complex Preparations (BE-Validated Clinical)", invited Dr. Li Zhengqi, Chairman of Nanjing Lighting Pharmaceutical Technology Co., Ltd., Director of the Laboratory of Chongqing Dinali Pharmaceutical Technology Co., Ltd., Dr. Yuhuan, Vice President of Pharmaceutical Intelligence Network, Senior Engineer Mr. Li Tianquan, Andreu, Director of the Chinese Pharmaceutical Society and Vice Chairman of Sichuan Pharmaceutical Society, Mr. Song Minxian.
    , director of the Chinese Pharmaceutical Society and vice president of the Sichuan Pharmaceutical Society, presided over the meeting salon scene full of high-level, unprecedented event! Good Doctor Pharmaceutical Group, Yangzijiang Pharmaceutical Group, Taiji Group Sichuan Taiji Pharmaceuticals and other more than 30 pharmaceutical enterprise leaders attended the meeting, with experts and scholars gathered to discuss high-variation drugs and complex preparations clinical research topics.
    At present, 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.
    First of all, dr. Li Zhengqi, Chairman of Nanjing Lighting Pharmaceutical Technology Co., Ltd., brought a report on the "Difficult Drug Clinical Trial Program Design, Implementation and Verification Points", which deeply analyzed the success stories in terms of the implementation points of the operation of clinical trials of high-difficult drugs, the key points of CFDI on-site verification and the precautions.
    noted that clinical verification of complex preparations should focus on key aspects such as project screening success rates, data traceability, medical records of clinical research processes, and folder reviews.
    and summarized the main points for everyone as "clinical program design is the key, clinical trial implementation to standardize, verification of the problem response skills, registration and declaration communication must be timely" four sentences smoothly, out of the key to solve the problem.
    Dr. Li Zhengqi, Chairman of Nanjing Lighting Pharmaceutical Technology Co., Ltd., followed by Dr. Yuhuan, Laboratory Director of Chongqing Dinali Pharmaceutical Technology Co., Ltd., made a report on the Challenges and Strategies of Bioanalytical Analysis of Complex Injection Fluids, which explores the difficulties of development and analysis of liposome drugs, nucleic acid drugs, ADCs and protein drugs.
    Gum Chongqing Dinali Pharmaceutical Technology Co., Ltd. Laboratory Director Dr. Yuhuan's speech was followed by a report by Mr. Li Tianquan, Vice President and Senior Engineer of Pharmaceutical Intelligence Network, on the development trend of long-acting preparations such as microspheres and liposomes.
    He pointed out that microspheres and lipids have the characteristics of prolonging drug action time, good targeting, enhanced efficacy, reducing side effects, high research and development costs, high technical barriers, and made an in-depth interpretation of the current development trend of long-acting preparations and the opportunities and challenges faced by domestic pharmaceutical companies in this emerging technology.
    also pointed out that under the pressure of collecting and collecting, breaking through technical barriers and identifying differentiated competition is the key. At the end of the speech by Mr. Li Tianquan, Vice President and Senior Engineer of
    Pharmaceutical Intelligence Network, the participants discussed the problems encountered in the clinical research of high-variation drugs and complex preparations, and the experts discussed the success stories in depth, and jointly discussed solving the difficulties of high-variability drug BE and clinical research, igniting the spark of innovation, and seeking the great cause of medicine.
    It is learned that in order to strengthen cooperation and exchanges within and outside the pharmaceutical industry, improve the level of pharmaceutical research and development, pharmaceutical technology, and promote the development of the pharmaceutical industry, co-sponsored by the Pharmaceutical Intelligence Network, Pharmaceutical Intelligence Elite Club, Pharmaceutical Intelligence Media supported by the 2020 Pharmaceutical Intelligence Salon activities will be carried out in ten cities across the country.
    for different salon themes, Drug Intelligence Network will be directed to invite the heavyweights of the pharmaceutical industry to attend, for the live guests to answer questions and puzzles.
    , in addition to the keynote speech, the site gives participants more opportunities to speak and discuss, improve the level of communication, solve difficult problems.
    background of the conference, the competition in the generic drug market has intensified, and the complex preparations with competitive advantage have 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 development of the consistent evaluation of generic drugs in China, 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, I believe that in the future in Nanjing Lighting Pharmaceutical Technology Co., Ltd., Chongqing Dinali Pharmaceutical Technology Co., Ltd. and other enterprises continue to work hard, we will usher in more high-variation drugs with independent intellectual property rights and complex preparation results.
    .
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