NMPA Research Base for Drug and Medical Device Regulatory Science Hainan Institute of Real World Data
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Hainan real research institute free welfare! Data quality control training class registration now!

2022-03-28 981

All relevant institutions:

Real-world data (RWD) and real-world evidence (RWE) are increasingly used to support drug device development and regulatory decision-making. Real, accurate, complete, reliable and high-quality data is the guarantee of effective and reliable clinical research results. Article 39 of the "Administrative Measures for Medical and Health Institutions Carrying out Investigator-Initiated Clinical Research (Trial)" issued by the National Health and Health Commission clarifies that medical and health institutions should establish a management system for clinical research source data, achieve centralized and unified storage, and ensure clinical Research the authenticity, integrity, standardization and confidentiality of data in the process of collection, recording, modification, processing and preservation, and ensure that the data can be queried and traceable.

In order to promote the smooth development of real-world research in medical institutions and related enterprises in Lecheng Park, help each unit improve the efficiency and accuracy of clinical research through an intelligent and information-based data collection mode, and at the same time enable the generated RWD to meet regulatory requirements. Regulations require that Hainan Real World Data Research Institute specially invites professors from Peking University and Beijing Children's Hospital and front-line experts in charge of clinical research from Tigermed to give lectures on the theme of "Data Quality Control in Real World Research". Staff responsible for scientific research, clinical, information systems, etc. of each unit are requested to actively participate. This training course does not charge any fees.

1. Organizer

Hainan Real World Data Research Institute

2. Training methods and locations

Personnel from medical institutions in the Lecheng Pioneer District will participate in the training offline. The offline training location is: Conference Room 3 of the Lecheng Administration Bureau; other personnel will participate in the training online. The link to the Tencent conference is as follows:

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3. Training objects

Professionals in drug regulatory agencies, review agencies, pharmaceutical equipment companies, medical institutions, scientific research institutes, colleges and universities, clinical research, statistics, institutional offices, medical affairs, registration, data management, as well as young and middle-aged backbones and graduate students.

4. Training time

April 2, 2022 9:00-17:30

V. Training Registration

(1) Registration method: For individual registration, please scan the following QR code. For group registration, please fill in the registration receipt and send it to lechengrws@163.com.

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(2) Deadline for registration: April 1, 2022

6. Training schedule

 

time    

theme    

speaker _    

9:00-09:05

leader's speech

Lecheng Administration Leadership

9:05-10:05

Research on integrated solution tools for real-world data collection, governance and management

Yao Chen (Peking University)

10:05-11:05

Practice of Real World Research Source Data Collection and Governance Based on ESR Tools

Tan Yun (Hangzhou Tigermed Medical)

11:05-12:05

Ethical requirements for real-world data research

Professor Zhang Haihong (Peking University)

14:00-15:00

Risk management during real-world data collection

Li Yanlong (Beijing Xintianhaohe Law Firm)

15:00-16:00

Key elements and case studies in the implementation of a device project in a real-world study

Sun Juan (Beijing Tigermed Medical)

16:00-17:00

Using ERS Tools to Improve Real-World Research Reporting Transparency and Regulation

Peng Xiaoxia Researcher (Beijing Children's Hospital)

17:00-17:30

online exam

  

7. Contacts

Zhang Zhongru 13697577980

Zhao Yuanyuan 19927522718