ICH Project ICH E2C (R2) Guideline information session ICH E2C (R2): Periodic Safety Update Report on Marketed Drugs (Revised)
December 02, 2011
The ICH E2C (R2) guideline 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, to introduce new concepts, and to remove some of the existing content. In addition, the guideline name will be changed from PSUR to Periodic Reporting with Benefit-Risk Evaluation (PBRER), which more fully emphasizes benefit-risk evaluation.
A briefing on the E2C (R2) Step 2 Guideline, including the background of the revision, was held this time. Approximately 200 people from not only pharmaceutical association 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 take the opportunity to submit comments based on the intent of these guidelines during the public comment period scheduled to follow this briefing session.
Date, time and place
| Date and Time | Location |
|---|---|
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Thursday, January 18, 2012, 13:00-16:45 |
Tower Hall Funabori Main Hall |
Information and Program
Lecture Materials
| Presentation | Speaker |
|---|---|
|
1 ICH E2C (R2) Step 2 Guideline Status and History, EU PV New Regulation (840KB) |
Japan Pharmaceutical Manufacturers Association |
|
2 ICH E2C (R2) Step 2 and Introduction (Guidelines 1.-1.3) (1,304KB) |
Japan Pharmaceutical Manufacturers Association |
|
Japan Pharmaceutical Manufacturers Association |
|
|
Japan Pharmaceutical Manufacturers Association |
|
|
5 Guidance on the structure and description of ICH E2C(R2) PBRER (Guideline 3.15 - 3.19) (2,660KB) |
Japan Pharmaceutical Manufacturers Association |
For inquiries, please contact
ICH Secretariat of the Pharmaceutical Manufacturers' Association of Japan
- Phone
- 03-3241-0326
The End