Addendum to E2C : Periodic Safety Update Reports for Marketed Drugs

Regulatory Resource: Addendum to E2C : Periodic Safety Update Reports for Marketed Drugs

Description:

Based on the comments made by the members of the Expert Working Group on CIOMS V recommendations and the PhRMA-EFPIA working document, this guideline has been finalised and reached Step 4 in February 2003. This Addendum should always be used in conjunction with the E2C Guideline.

The Addendum intends to provide further clarification and guidance in the preparation of PSURs as specified in E2C. Additionally, the document addresses some new concepts not in E2C but reflecting current pharmacovigilance practice needs, including Proprietary Information (Confidentiality), Executive Summary, Summary Bridging Report, Addendum Reports, Risk Management Program and Benefit-Risk Analysis.

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