On 24th October, ICH Guideline E19:Methods for Selective Collection of Safety Data in Specific Late Pre-market Clinical Trials or Post-market Clinical Trials, hosted by NMPA ICH Working Office, was successfully held. A total of more than 110 participants from domestic and foreign pharmaceutical companies, research institutes and representatives of drug regulatory agencies attended the event on site, and about 8200 people watched it online.
At the meeting, ICH E19 Expert Working Group (EWG) experts from Chinese and American regulatory agencies made an in-depth interpretation and detailed introduction of the drafting background, technical requirements and implementation of the E19 Guideline in China and the U.S. ICH E19 EWG experts from the industry, experts from the ICH E19 Domestic Expert Working Group (DEDWG), and domestic and foreign industry experts shared their understanding of the Guideline from the industrial perspective, and conducted relevant case studies. Experts from the industry, ICH E19 EWG experts, domestic expert working group and domestic and foreign industry experts shared their understanding of the guiding principles from the industrial point of view and shared relevant cases. The participants carried out in-depth exchanges on related hot issues.
The training further improved the understanding and understanding of the new concepts and methods proposed by the ICH E19 Guidelines, provided guidance for clinical trial sponsors on how to consider the use of selective collection of safety data, and helped to better promote the full implementation of the ICH E19 Guidelines in China.
Reference: https://www.cde.org.cn/main/newspic/view/e38cfa645e418eaf136cc011b4a6a34d
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