Drug Evaluation Committee Education and Training Materials for the E2B(R3) Explanation
Electronic Standard for Medical Information Expert Committee
April 2024
In Japan, reporting by ICH E2B(R3) to the Pharmaceuticals and Medical Devices Agency has become mandatory as of April 1, 2019. For smooth handling of adverse drug reaction reports, the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association has published the "Guidance for Electronic Reporting of Adverse Drug Reactions and Infectious Disease Cases" (latest edition*: issued in September 2022). In actual training, I am sure that the training materials are prepared in accordance with the experience and knowledge of the target audience. To help pharmaceutical companies implement training more efficiently and appropriately, and to reduce the burden on training personnel in preparing training materials, we have prepared training materials at Electronic Standard for Medical Information Expert CommitteeTF2-1.
- *Items related to side effects of control drugs and concomitant drugs used in addition to the study drug have been added in accordance with the revision of the Pharmaceutical Affairs Law enforced in September 2020. Details of the updated contents are listed on the last page of each material.
Published March 2020
Revised April 2024*.
Cautions for use
- The information in this material is based on current information. Please note that future trends may change the situation.
- PDF files (originals created at Electronic Standard for Medical Information Expert Committee) may not be modified.
- The PPT file can be modified and used as appropriate at the responsibility of each company, but we are not responsible for the content after modification.
Explanation of E2B(R3) - Introduction
Materials designed to provide an overview of E2B(R3) and prepare those who are new to E2B(R3) and those who wish to review E2B as they transition to E2B(R3) in order to understand the details of the new system.
| File | Hash value (*) (MD5) |
|---|---|
| Download (1.4MB) (slides only) | a64917e4226295c8446f2b5475621004 |
| Download (1.3MB) (with notes) | 674bb6fd48265de090e15d17d50fd524 |
| Download (1.4MB) (with notes) | 0c0c8197f941a80b236e9646c50e1c1b |
E2B(R3) Explanation-Practical Use
Materials for those who have knowledge of E2B(R2) and those who were engaged in electronic reporting of adverse drug reactions in E2B(R2) to understand the changes from E2B(R2) and the details of E2B(R3).
| File | Hash value (*) (MD5) |
|---|---|
| Download (1.3MB) (slides only) | b330ae15b8399a0aa24c0970b369bcdd |
| Download (1.3MB) (with notes) | 41a5e45b6e328cba9f8b42b0beec6790 |
| Download (1.2MB) | 15d6660fc65555ad8db7d10100762220 |
- *A file with a hash value different from the above indicates that it has been modified from the original.