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E2D(R1) DISAPPROVAL SAFETY DATA: DEFINITIONS AND STANDARDS FOR MANAGEMENT AND REPORTING OF INDIVIDUAL CASE SAFETY REPORTSThis draft guidance, when finalized, will represent the current thinking of

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Review the specific requirements outlined in ICH E2Dr1 guideline

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Collect relevant data and documentation for the regulatory submission

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Complete each section of the guideline accurately and thoroughly

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What is ich e2dr1 guideline on?

ICH E2DR1 guideline is on post-approval safety data management.

Who is required to file ich e2dr1 guideline on?

Marketing authorization holders are required to file ICH E2DR1 guideline.

How to fill out ich e2dr1 guideline on?

ICH E2DR1 guideline should be filled out according to the specified format and requirements outlined in the guideline.

What is the purpose of ich e2dr1 guideline on?

The purpose of ICH E2DR1 guideline is to provide guidance on post-approval safety data management.

What information must be reported on ich e2dr1 guideline on?

ICH E2DR1 guideline requires reporting of safety data from post-approval studies and sources.

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