ICH Project ICH E2C (R2) Guideline Workshops ICH E2C (R2): Periodic Safety Update Report on Marketed Drugs (Revised)
December 02, 2011
Periodic Safety Update Reporting for Over-the-Counter Drugs (PSUR) is based on the Periodic Safety Update Reporting (PSUR) for Over-the-Counter Drugs (E2C) and its addendum (E2C(R1)). The E2C(R2) guideline will be completely revised to make it consistent with the handling of other clinical safety data, introduce new concepts, and remove some of the previous content. In addition, the guideline name will be changed from PSUR to Periodic Reporting with Benefit-Risk Evaluation (PBRER).
This time, we held a Guideline Workshops on E2C (R2) Step 2, including the background of the revision. Approximately 200 people from not only JPMA member companies but also from a wide range of related companies participated in the session, which was followed by a lively question-and-answer session.
We hope that everyone will participate in the public comment period scheduled after the Guideline Workshops and provide comments based on the intent of these guidelines.
Date, time, and place of the meeting
| Date and Time | Location |
|---|---|
| Thursday, January 18, 2012, 13:00-16:45 | Tower Hall Funabori Main Hall |
Information, Program
Information and Program (172KB)
Lecture Materials
| Presentations | Speakers |
|---|---|
| 1 ICH E2C (R2) Step 2 Guideline Status and History, EU PV New Regulation (840KB) | Japan Pharmaceutical Manufacturers Association |
| 2 ICH E2C (R2) Background to Step 2 and Introduction (Guidelines 1.-1.3) (1,304KB) | Japan Pharmaceutical Manufacturers Association |
| Japan Pharmaceutical Manufacturers Association | |
| 4 Guidance on the structure and description of ICH E2C (R2) PBRER (Guideline 3.1 - 3.14) (1,815KB) | Japan Pharmaceutical Manufacturers Association |
| 5 Guidance on the structure and description of ICH E2C (R2) PBRER (Guidelines 3.15 - 3.19) (2,660KB) | Japan Pharmaceutical Manufacturers Association |