E2B Q&As (R5): Questions and Answers

Regulatory Resource: E2B Q&As (R5): Questions and Answers

Description:

Since reaching Step 4 and publication within the ICH regions as E2B(R1) in November 2000, experiences by all parties with the implementation of the First Revision of the E2B Guideline have resulted in the need for some clarification. This supplementary Questions and Answers document intends to clarify key issues.

Please note that the Implementation Working Group has been discontinued in November 2004. Therefore, all technical questions should now be addressed to the regional Regulatory Authorities.

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