Big shots! The 2021 Real World Research Theory and Practice Workshop is calling for you to sign up

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Big shots! The 2021 Real World Research Theory and Practice Workshop is calling for you to sign up

2021-12-08 1005

Notice on the 2021 Real World Research Theory and Practice Training Course

All relevant units:

Hainan Boao Lecheng International Medical Tourism Pilot Zone is my country's first pilot area for the application of clinical real-world data. Since the pilot work was launched in 2020, more than 20 medicinal products have been included in the pilot, of which 3 medicinal products have been tested by using the Lecheng Clinic. The real-world data has been approved by the State Food and Drug Administration for marketing, and a certain amount of real-world research and practice experience has been accumulated.

In order to improve researchers' understanding and understanding of real-world theory, and further promote the development of real-world research in the Lecheng Pilot Area and even in my country, the Hainan Real World Data Research Institute, the Hainan Food and Drug Administration Vocational Skills Training Center, and the Boao Lecheng Clinical Research Center It is planned to jointly hold the 2021 Real World Research Theory and Practice Training Course in mid-to-late December 2021. The specific arrangements are as follows:

1. Organizer

Hainan Real World Data Research Institute, Hainan Food and Drug Management Vocational Skills Training Center, Boao Lecheng Clinical Research Center

2. Training methods and locations

The staff of medical institutions in the Lecheng Pioneer District participated in the training offline. Training location: No. 5 Kangxiang Road, Lecheng Pioneer District, Qionghai City, Hainan Province, Hainan Qiyan Hospital Lecture Hall.

Others attend training online. The meeting link will be notified later.

3. Training objects

Personnel involved in clinical research of drugs and medical devices, such as drug regulatory agencies, review agencies, pharmaceutical and device companies, medical institutions, scientific research institutes, colleges and universities, CRO companies, etc.

4. Training time

December 17, 2021 08:50-17:30

5. Training content

(1) Policy management and real-world research on special medicinal devices in Lecheng Pioneer Area

(Director Li Yaohua of Hainan Drug and Medical Device Evaluation Service Center)

(2) Lecheng's guidelines for conducting real-world research on drug registration

(Professor Chen Pingyan, Executive Director of Hainan Real World Data Research Institute and former Director of the Department of Biostatistics, Southern Medical University)

(3) How to ensure the reliability of real-world data

(Professor Yao Chen, Vice President of Hainan Real World Data Research Institute and Director of the Medical Statistics Office of Peking University First Hospital)

(4) Real-world data research and application innovation

(Professor Sun Xin, Vice President of Hainan Real World Data Research Institute, Director of China Evidence-Based Medicine Center, West China Hospital, Sichuan University)

(5) Exploratory practice of real-world research on eye diseases in Boao Lecheng

(Professor Chen Wei, postgraduate tutor of Hainan Real World Data Research Institute and Vice President of Wenzhou Medical University Affiliated Ophthalmology Hospital)

(6) Practice and exploration of US FDA guidelines related to real-world evidence

(Dr. Lai Junkai, Department of Medical Statistics, Peking University First Hospital)

6. Training registration

(1) Registration and payment: The training fee is 300 yuan per person (the staff of the medical institutions in the Lecheng Pioneer District are exempt from the training fee). For registration and payment, please scan the following QR code:

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(2) Deadline for registration: 17:00 on December 16, 2021

Attachment: Introduction of the teacher

Hainan Real World Data Research Institute

December 7, 2021

(Contact: Zhao Yuanyuan 19927522718, Wu Dandan 13786276238)

Teacher introduction

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Chen Pingyan

Professor, doctoral supervisor, postdoctoral co-supervisor, executive director of Hainan Real World Data Research Institute, former director of the Department of Biostatistics of Southern Medical University (1997-2019). Established the first biostatistics department in China (2004), and took the lead in opening a biostatistics undergraduate major in China (2005). Chairman of Biostatistics Branch of Chinese Preventive Medicine Association, Vice Chairman of China Branch of International Biostatistics Society, President of Guangdong Biostatistics Society; expert in major administrative decision-making in Guangzhou. He has published more than 280 papers, including more than 80 papers included in SCI, which have been published in SMMR, SIM, NEJM, JAMA, JCO, JAMA-IN, ERJ, JASN, Radiology and other journals, with a cumulative impact factor of more than 500. Editor-in-chief of "SPSS Statistical Software Application Tutorial" series of postgraduate planning textbooks have a wide range of influence.

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Yao Chen

Professor, PhD supervisor. Deputy Director of Hainan Real World Data Research Institute, Director of the Medical Statistics Office of Peking University First Hospital, and Deputy Director of Peking University Clinical Research Institute. Major academic appointments include the chairman of the Evidence-Based Medicine Professional Committee of the Chinese Medical Doctor Association, the vice chairman of the Statistical Theory and Methods Professional Committee of the Chinese Medical Statistical Society, the vice chairman of the Real World Research Professional Committee of the World Federation of Chinese Medicine Societies, and the Wu Jieping Medical Foundation Oncology Department. Deputy chairman, expert in the drug/device review expert database of the State Food and Drug Administration. Participated in Johnson & Johnson's real-world research project on cataract femtosecond aurora in Boao Lecheng, and used the real-world data of the research process to explore the automated acquisition process. The methodology research paper has been published in the 2020 Issue 11 of "China Food and Drug Administration" (special issue of scientific and innovative technology research on drug device supervision).

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Sun Xin

Professor, researcher, doctoral supervisor, director of the China Center for Evidence-Based Medicine, West China Hospital, Sichuan University, director of the Hainan Key Laboratory of Real World Data Research and Evaluation of the State Food and Drug Administration, director of the Sichuan Real World Data Technology Innovation Center, and director of the Cochrane China Center, Director of MAGIC China Center, Vice President of Hainan Real World Data Research Institute, Executive Editor of "Chinese Journal of Evidence-Based Medicine" and "Journal of Evidence-based Medicine", Chairman of Real World Research Committee of China Association of Traditional Chinese Medicine, Chinese Medical Doctor Association Vice-chairman of the Evidence-Based Medicine Committee, won the BMJ Outstanding Achievement Award (for the first time awarded to Chinese researchers).

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Chen Wei

Professor, Chief Physician, Doctoral Supervisor. Postgraduate tutor of Hainan Real World Data Research Institute, vice president of Wenzhou Medical University Affiliated Ophthalmology Hospital, president of Ningbo Eye Hospital, director of Ophthalmology Center of Boao Super Hospital, expert member of Chinese Ophthalmology Society, Ophthalmology Branch of Chinese Medical Doctor Association Ophthalmology Branch Deputy director of the group, member of the 9th-11th session of the Chinese Ophthalmology Association Corneal Disease Group, founding director of the Asian Dry Eye Society, member of the Ophthalmic Surface Group of the Ophthalmology Branch of the Maritime Medical Association, and editorial board member of the Chinese Journal of Optometry and Vision Science, Asia Pacific Editorial Board Member of the Journal of Ophthalmology. Selected as a high-level innovative talent in health care in Zhejiang Province.

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Lai Junkai

Department of Medical Statistics, Peking University First Hospital, Ph.D. student in clinical research methodology of Peking University Clinical Research Institute, has rich experience in clinical research program design, real-world data research, and big data analysis. In the US medical insurance industry, he has many years of experience in data analysis using real-world data for population health management. Participated in the research of CDISC international real-world data docking, the translation of OHDSI data standardization system, and the promotion of various standards in China.

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