Drug Evaluation Committee Mini-Seminar on Electromagnetic Compliance" on December 21, 2022

December 21, 2022

At the "Mini-Seminar on Electromagnetic Compliance" on December 21, 2022, in addition to the explanation of the "Procedures for Receiving and Storing Archived Clinical Trial Documents (model)" prepared by Japan Pharmaceutical Manufacturers Association, the current status of electronic clinical trials and future prospects, as well as the risks to be recognized when contracting with cloud system vendors, will be introduced. In addition, we introduced the current status of electronic clinical trials and future prospects, as well as points to be aware of as risks when contracting with cloud system vendors. In addition, the Reliability Assurance Department of the Pharmaceuticals and Medical Devices Agency (PMDA) was invited to explain how to respond to GCP site inspections using data obtained through data migration (archived data).
The importance of proper handling of archived data has been increasing due to the termination of the cloud system service for clinical trial-related documents. If archived data is not created and stored using appropriate means, the reliability of the data will be damaged and it will lose its value as electromagnetic records. We hope that this seminar will help promote (optimize) the use of electromagnetic records for clinical trial-related documents and the digitization of clinical trial-related documents to improve Japan's internationally competitive drug development environment.

Please click below to watch the video of the lecture on the day of the seminar

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