Following our successful webinar in March, we are pleased to announce the second in a series of seminars on China’s Center for Drug Evaluation (CDE) guidance at Proswell University, hosted by our Chinese partner Proswell Medical Company.
On January 15th, 2021, China’s CDE published guidelines on imaging criteria for anti-tumor drug clinical trials. In recent years, there have been a large number of clinical trials related to anti-cancer drugs in China, and more and more clinical trials are using medical imaging evaluation from the early stage of development.
In this presentation, we will compare the CDE guidance with the Clinical Trial Imaging Endpoint Process Standards Guidance for Industry published by the US FDA and provide examples based on our own experience.
Date and time:.
Tuesday, April 13th, 2021, 16:00-17:00 Japan time (15:00-16:00 Beijing time)
Speaker: Zheng Tong, Department of Image Analysis Micron, Inc.
Title (all in Chinese):
1.Understanding the differences in evaluation results
– Common misunderstandings
– Differences between institutional evaluations and independent evaluation committee evaluations
– Differences between Independent Review Committee Evaluators
2.Quality control of medical images
– Explanation of guidance content
3.Quality control for independent assessment
– Explanation of guidance content
4.Reference points for the quality of independent image assessment services
– Explanation of guidance related content
– Requirements
Registration Fee: Free of charge.
Advance registration via Proswell Medical Company’s WeChat site is required.
https://mp.weixin.qq.com/s/KGQIp9UCSi0UUIxKS-4XJA
Category
Please feel free to contact us
We provide comprehensive, end‑to‑end clinical development support, with imaging at its core.
With more than 20 years of experience, our team of imaging specialists in Japan and around the world tackles the complex challenges of imaging evaluation in pharmaceutical and medical device development. We deliver optimal, project‑specific solutions for each client.