Here comes the big shot! Registration for the real World Research drug clinical trial training cours

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Here comes the big shot! Registration for the real World Research drug clinical trial training cours

2021-08-12 828

Notice on Holding the 2021 Real World Research Drug Clinical Trial Training Course

All relevant units:

In order to promote the construction of drug clinical trial institutions nationwide and in the Hainan Boao Lecheng International Medical Tourism Pilot Zone, strengthen the clinical trial related staff's grasp of GCP and other knowledge, ensure the smooth development of clinical trials, cultivate first-class research teams and research hospitals, accelerate Promote real-world research. Based on the actual situation of the Lecheng Medical Pilot Zone, Hainan Real World Data Research Institute and Boao Lecheng Clinical Research Center will hold the 2021 Real World Research Drug Clinical Trial Training Course for the whole country on August 30, 2021. The relevant matters are hereby notified as follows:

1. Organizational Structure

Organizer: Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration

Organizer: Hainan Real World Data Research Institute

Boao Lecheng Clinical Research Center

Supporting unit: Hainan Pharmaceutical Industry Association

Professional Committee of Clinical Pharmacy of Hainan Medical Association

Hainan Provincial Innovative Drug Clinical Evaluation Engineering Center

Second, the training object

Persons in charge of various medical institutions, drug production, drug R&D institutions, CRO companies in drug R&D, clinical research, GCP application, ethics review and other departments and staff in related positions.

3. Training time

The training time is 9:00-17:30 on August 30, 2021.

4. Training location

This meeting will be held online, and the access method will be notified separately.

5. Training content

(1) R&D and clinical transformation of medicinal devices --- Xie Xingwang (Beijing Kerui Biotechnology Co., Ltd.)

(2) Comparison of China's new version of GCP and international supervision - Shen Yifeng (Shanghai Mental Health Center Institutional Office)

(3) Filing of medical device clinical trial institutions and construction of research system---Xu Chongyuan (Ph.D., Southern Medical University)

(4) Statistical considerations in the design of clinical research programs --- Yao Chen (Vice President of Hainan Institute of Real World Research)

(5) Quality management system of the sponsor's clinical research --- He Yi (Tailan Pharmaceutical)

(6) Data management and source data traceability inspection of clinical research --- Yao Chen (Vice President of Hainan Real World Research Institute)

(7) Ethical review of clinical research protocols --- Su Yuju (Hainan Medical College)

6. Training registration

(1) Registration method: scan the QR code and fill in the registration receipt

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(2) Deadline for registration: 17:00 on August 26, 2021

(3) The training fee is 500 yuan per person. Name of payment account: Hainan Real World Data Research Institute; Account Number: 2201025319200154180; Account Bank: Industrial and Commercial Bank of China Qionghai Sub-branch. Please note "GCP training" when remittance.

Contact: Wu Dandan 13786276238

Zhao Yuanyuan 19927522718

Attachment: Introduction of the teacher

Hainan Real World Data Research Institute

August 12, 2021

Teacher introduction

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Yao Chen

Professor, doctoral supervisor. Vice President of Hainan Real World Research Institute, Director of Medical Statistics Office of Peking University First Hospital, and Deputy Director of Peking University Clinical Research Institute. Main academic appointments: Chairman of the Professional Committee of Evidence-Based Medicine of the Chinese Medical Doctor Association, Vice Chairman of the Professional Committee of Statistical Theory and Methods of the Chinese Society of Health Statistics, Vice Chairman of the Professional Committee of Real World Research of the World Federation of Chinese Medicine Societies, 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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Xu Chongyuan

Ph.D., chief pharmacist/professor, postgraduate tutor, currently the director of the National Drug Clinical Trial Institution Office, the director of the Drug Clinical Trial Center, the director of the Phase I Clinical Research Office, and the director of the Guangzhou-Hong Kong New Drug Clinical Research Cooperation Center of the Southern Hospital of Southern Medical University. Adjunct professor and postgraduate tutor at Jinan University and Guangzhou Medical University; he was a visiting scholar at the Clinical and Translational Research Center of Vanderbilt University and a visiting professor at the City of Hope Medical Center in the United States.

Served as the chairman of the Drug Clinical Evaluation Research Committee of the Chinese Pharmaceutical Association, the deputy chairman of the drug clinical trial specialty of the Chinese Pharmacological Society, the GCP inspector of the Audit and Inspection Center of the State Food and Drug Administration, and the executive editorial board member of the Chinese Journal of Clinical Pharmacology of the Chinese Pharmaceutical Association. He is also the deputy director of the editorial department, the vice chairman of the Medical Ethics Branch of the Guangdong Provincial Hospital Association, a member of the Standing Committee of the Ethics Branch of the Guangdong Medical Association, and a member of the Ethics Expert Committee of the Guangdong Health and Health Commission. In November 2017, the China Clinical Research Capability Improvement and Subject Protection Summit Forum (CCHRPP) and a consortium of member units were established. In May 2018, the Guangdong-Hong Kong-Macao Phase I & BE Clinical Research Sharing Joint Platform was launched.

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Xie Xingwang

Chairman and CEO of Beijing Kerui Biotechnology Co., Ltd., member of China Anti-Cancer Association, member of the Professional Committee of Clinical Application of Medical Biotechnology. Led the Kerui Biotechnology team to independently develop innovative TCR drugs, and has applied for a number of PCT patents, national invention patents, utility model patents and computer software. He also serves as a member of the Multidisciplinary Diagnosis (MDD) Collaborative Group of the Tumor Markers Professional Committee of the China Anti-Cancer Association, a member of the Medical Biotechnology Clinical Application Professional Committee of the Chinese Society of Biomedical Technology, and a member of the Youth Federation of Changping District, Beijing.

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Shen Yifeng

Director of Institutional Office and Ethics Committee of Shanghai Mental Health Center, Certified Research Physician (CPI®) by American Association of Clinical Research Professionals (ACRP). Master and Ph.D. of Shanghai Medical College of Fudan University, senior visiting scholar of Rutgers New Jersey Medical School in the United States, deputy team leader of the GCP platform for "major new drug creation" psychotropic drugs in the 11th, 12th and 13th Five-Year Plan, concurrently serving as NMPA drug review expert and GCP inspector, core member of China QA Forum (CQAF).

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He Yi

Deputy Director of Audit and Training of Tailan Pharmaceuticals, 13 years + experience in drug clinical trials, responsible for clinical trial management, training and audit work in well-known CROs at home and abroad, rich experience in internal training of Tailan, and participated in external training and courseware of Tailan for many times Development, more than 100 project audit experience, including research center audit, SOP system audit From 2017 to 2021, participated in clinical trial data verification support work for many times.

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Su Yuju

Doctor of Jurisprudence from Tsinghua University, visiting scholar at Georgetown University Law Center; Deputy Dean (presiding over the work), professor and master tutor of the School of Marxism, Hainan Medical College; the first batch of "South China Sea Famous Masters" in Hainan Province, Hainan Provincial "Leading Talent", the first batch of "Double Hundred" talent team leaders in Hainan Province.

Concurrently: Vice-Chairman of Coordination Center of Chinese Member Units of UNESCO Bioethics Education Promotion Organization; Executive Director, Academic Committee Member and Deputy Secretary-General of Chinese Society of Health Law; Executive Director of Health Ethics Professional Committee of Chinese Ethics Society; Chinese Medical Doctor Association Humanities Medicine Member of the Professional Committee; President of Hainan Provincial Health Law Society; Vice Chairman of the Professional Committee of Medical Ethics of Hainan Medical Association, etc.

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