The scientific research and supervision industry has been resonant from a pharmaceutical power to a pharmaceutical power

In January 2020, the outbreak of the new crown epidemic, crisis and challenges in parallel, Jinqiu October pharmaceutical colleagues can gather in the beautiful Jinji Lake to hold the annual meeting and exhibition of China's DIA, which is closely linked to China's great victory in the fight against the new crown epidemic.
October 28, the DIA Annual Meeting opened in Suzhou.
the conference set up 15 academic topics, more than 90 academic sessions, 7 pre-session topics, aimed at strengthening the promotion of international exchanges and cooperation in the field of Chinese and foreign medicine.
invited a large number of academic and industrial experts, as well as the leadership of regulatory bodies, to discuss with practitioners to promote innovation and cooperation.
, General Manager of DIA China, jointly opened the meeting with Xue Bin, Director of the China Food and Drug International Exchange Center.
the conference was: Meet the challenge, focus on innovation, and strengthen a patient-centered public health system.
: From a pharmaceutical power to a pharmaceutical power, Xu Jing, deputy director of the State Drug Administration, attended the opening ceremony of the annual meeting of China's DIA.
xu Jing and the deputy director said that since its establishment in 2018, the State Drug Administration has adhered to xi Jinping's new era of socialist ideology with Chinese characteristics as a guide, firmly established the people-centered development ideology, and resolutely adhered to the "four most stringent" drug supervision.
And visually summarize the drug regulatory work as a development path, that is, accelerate the leap from a pharmaceutical power to a pharmaceutical power, two basic tasks, both to protect and promote public health, to protect the safety bottom line, to pursue the development of high line, the three governance concepts, that is, risk management, responsibility governance, intelligent governance, four development path: scientific, rule of law, internationalization, modernization, five major construction themes: innovation, quality, efficiency, system and capacity.
Xu Jing and the Deputy Director-General then introduced to all the participants in the conference the main reform and innovation work of the State Drug Administration in recent years: First, to accelerate the scientific development of drug supervision;
Xu Jing and the deputy director shared their insights on drug information, "In the era of globalization and informationization, information is to industry, as money is to the economy, information to regulation is like blood to life, information to the public, as air is to all things."
the degree of possession of information, often reflects your vision, the speed of information, often reflects your ability, the sharing of information, often reflects your mind.
" Finally Xu Jing and the deputy director of the pharmaceutical people from all walks of life put forward the promise, in order to promote China's strategic implementation from a pharmaceutical power to a pharmaceutical power, we need to speed up the construction of a more modern policy and regulatory system, accelerate the cultivation of more outstanding innovation ability, cultivate a high-quality industrial groups.
should always be open-minded and work together to build a community of human health and health.
Wang Chen Keynote Speech Research Institutions in collaboration with pharmaceutical companies to accelerate drug research and development Thinking The first keynote speaker was Wang Chen, a member of the Chinese Academy of Engineering and president of the Beijing Concord Medical College of the Chinese Academy of Medical Sciences.
's theme is "Research institutions in collaboration with pharmaceutical companies to accelerate drug research and development thinking."
first confirmed that domestic drug research and development, whether from the new drug species or from the research and development conditions, has become more and more close to the degree of internationalization.
also objectively pointed out that for other countries, the current domestic original research capacity is insufficient, clinical research and development personnel and management personnel lack of international vision and experience.
The current development of new technologies, such as discovery and application of innovative targets, gene editing technology, regenerative medicine, big data, blockchain, artificial intelligence, has brought opportunities and challenges to pharmaceutical research and development, and has also put forward new requirements to all industry insiders.
Wang Chen shared with the State Drug Administration and the Chinese Academy of Medical Sciences, as well as the Beijing Concord Medical College, the establishment of the Institute of Drug Devices Supervision and Research to strengthen the capacity-building of regulatory science under the new ecology.
also called on research institutions to work with pharmaceutical companies to build a development community, so as to integrate technology platforms and achieve information sharing under the leadership of the drug regulatory department to serve innovative drug research and development.
Sethree Wang Chen advocates to take data as the grasping hand, build a national drug clinical big data platform based on "informationization and AI plus big data", and build a specialized clinical trial complex with model as the grasping hand, forming standardized sharing, data sharing, resource sharing, ethical mutual recognition.
to promote the integration and linkage of drug clinical trial norms, drug review norms and drug application guidelines, to promote the intensive training of clinical trial personnel of high quality, and to use emerging technologies to promote new drug reform to digital and intelligent direction.
finally, Academician Wang Chen introduced the mission of the Chinese Academy of Medical Sciences to build the core base of China's medical science and technology innovation system, and also called for more and broader research institutions, clinical institutions and collaborative innovation among enterprises.
Tan Lingshi: Meeting the Challenge and Strengthening International Collaboration DIA Global Board Chairman Dr. Tan Lingshi, on behalf of the DIA Global Board of Directors and DIA colleagues around the world, expressed his sincere congratulations on the victory of this year's only offline annual meeting and exhibition.
this year's new crown outbreak has ignited global challenges, DIA China has rapidly launched the China Clinical Trials Sustainability Program, actively promoted the development of remote digital clinical trials under the outbreak, and actively assumed the responsibility of connecting, guiding and strengthening international cooperation.
Li Zhengqing: The new crown epidemic, the era of innovation, and the new generation of research and development force Li Zhengqing as the 2020 DIA General Assembly President, with the new crown epidemic, innovation era, and the new generation of research and development force three perspectives made a conference speech.
is the new crown outbreak.
DIA organized a number of online discussions, the conference also provides face-to-face in-depth exchange opportunities.
second is the age of innovation.
12 years since DIA came to China, he has witnessed and participated in China's health care reform, resonant with China's increasingly open and innovative environment.
see a breakthrough in FDA approval for local BTK inhibitors in China, as well as a growing number of multinational pharmaceutical companies incorporating China into their global strategy for new drug research and development.
is once again the research and development force of the new generation.
new crown outbreak, a large number of young experts, medical personnel, business workers and volunteers into the development of new drugs and vaccines.
the same with the DIA, the Youth Advisory Group became the mainstay of the association.
Li hopes that DIA's young experts will continue to make progress, deepen exchanges and collaboration with senior experts, and give full play to the role of the Internet and new media platforms.
the heart has fire, the eyes have light, so that DIA work continues to face the future, so that China's new drug research and development has world influence.
Wang Ping keynote speech to deepen the reform of the review and approval system and promote the development of high-quality drugs The theme of Wang Ping, Director of the Drug Registration Department of the State Drug Administration, is to deepen the reform of the drug review and approval system and promote the development of high-quality drugs.
and from the reform results, the current work and the next three dimensions of consideration made a wonderful presentation.
first, Director Wang Ping introduced the three stages of the reform of the drug review and approval system according to the timeline, from improving the quality in 2015, encouraging innovation in 2017 to innovation in 2019.
After the State Drug Administration has adopted a series of reform measures, the initial results achieved include, first, the speed of drug review and market access has been greatly enhanced, the availability of drugs is more secure, and second, the quality has been steadily improved, including the consistent evaluation of the quality and efficacy of generic drugs.
the key reform work that has been continuously promoted at present is to revise the management methods for drug registration, promote the innovation and development of traditional Chinese medicine heritage, optimize the management of drug clinical trials, and formulate change management after the drug is marketed.
, the newly revised drug registration management method highlights the management attributes, while technical issues remain in the supporting documents.
to encourage innovation and strengthen life-cycle management, further reducing the time between review and approval to the drug market.
, promote the development of chinese medicine heritage and innovation, reform and improve the chinese medicine review and approval mechanism, speed up the listing of Chinese medicine.
, the reform of the registration classification of Chinese medicine, second, pay attention to human experience, third, pay attention to clinical needs and values.
third, optimize the management of clinical trials of drugs, clinical value-oriented.
is now GCP certification cancelled, GLP certification is still to be emphasized.
clinical trial institutions from certification to filing system, but requirements and all aspects of supervision and inspection standards will not be lowered, may be further strengthened.
, emphasizing that after the drug is on the market, the trial-related work must be completed on time in accordance with the requirements of the batch.
and establish a change control system by the holder to implement the three types of changes in the Drug Administration Law.
Wang Ping finally shared the next step of the drug review and approval system, one is to improve the construction of the regulatory system, including registration management methods supporting documents and technical guidance.
is to continue to strengthen capacity-building, including the construction of teams of reviewers and inspectors.
Thend is to encourage and guide innovative research and development, speed up the review and approval of drug market, steadily promote consistency work, promote the correct innovation of Chinese medicine, solve the historical legacy of registration management, and work with industry colleagues to safeguard public health to make due contributions.
Theresa MULLIIN Keynote Speech: Patient-Centered Regulatory System Dr. Theresa MULLIIN, Deputy Director of the FDA Drug Review and Research Center (CDER) and Head of Strategic Affairs, shared the keynote address on "Patient-Centered Regulatory System."
at this critical stage of clinical research and development, it is important to identify what is important to patients and integrate patient engagement into research and development design to design better clinical research.
patient engagement allows regulators to better assess risk benefits throughout the life cycle of drug development.
patient involvement can better identify which clinical outcomes and study endpoints are more meaningful to the patients themselves.
patient participation can better measure the effectiveness and effectiveness of clinical trial implementation programs.
materials developed with patient involvement can be used to better inform and educate other patients.
FDA has established programs and guidelines to make it feasible to include patient opinions.
, patient-centered regulatory systems, patient considerations help research and development departments and regulators make better decisions.
, Vice Mayor of Suzhou City, on behalf of the Suzhou Municipal Government, extended a sincere welcome to DIA for holding the 2020 Annual Meeting and Exhibition in Suzhou.
14 years ago, Suzhou built the Biopharmaceutical Industry Park, as one of the earliest biopharmaceutical industry incubators in China, which is closely related to the pharmaceutical industry, and looks forward to further strengthening cooperation with DIA in the future.
the opening ceremony of the China Innovation Forum, a special discussion on "China's Innovative Drugs to the World's Impact of China's Innovative Drugs on Global Drug Development" was held. The
Forum was hosted by Dr. Wang Jinsong, Founder of Platinum Pharmaceuticals, and was attended by Agnes Saint-Raymond, Head of International Affairs at EMA; Anda Shang, Director of the Office of International Regulatory Affairs, Drug Safety and Environmental Health Bureau, Ministry of Health, Japan; Wang Jin, Global Partner of McKinsey; Lu Wei, Director of Lung Cancer Center, Shanghai Chest Hospital; Wang Lei, Senior Vice President, Global Research Clinical Operations and Biostats and Asia Pacific Clinical Development; and Wang Yiqing, Co-Investment Partner of GaoSheng Capital Group.
Saint-Raymond and Anda Shangshi spoke from a regulatory perspective: emphasizing transparency and sharing of information among national regulators and encouraging companies, especially Chinese pharmaceutical companies, to share information with regulators.
in the drug development process, companies should communicate with regulators earlier and proactively try to involve patients earlier.
: Five years ago, he and Dr. Jinsong and other core members of the Chinese pharmaceutical ecosystem to think about and propose sustainable development.
review of the rapid development over the past five years, we find that china's ecosystem has two unique characteristics: one is its diversity, the other is its symblotic power.
As a clinician, Professor Lu Wei shared a look at China's biomedical ecosystem from the "third eye": First, to open up barriers to the flow of talent in scientific research and industry, to strengthen the training of talents, especially leading talents;
look forward to using the diverse ecosystem to make an early appearance of China's Takeda and go to the world.
: Five years ago, China's pharmaceutical industry rarely mentioned first in class, the current drug review and approval reform has given birth to hatching this ecosystem, China's first in class has been called out for the future.
biotech, which is in the early stages of development, should pay more attention to scientific research and innovation, taking the lead in technology and target.
Ano Qing: "As described in "Long Song Line" 'Yangchun Budze, everything shines', the spring sun shines on the earth, everything recovers and grows, China's biopharmaceutical industry will also usher in a vigorous development.
ushered in an era of great dividends for good scientists and engineers.
investment institutions as a link to bring talent into the biopharmaceutical industry and promote the development of the industry.
hope that more enterprises are committed to the world's latest or optimal, based in China, to the world.
"