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15 June 2019 EMA/25090/2002 rev.19* Scientific & Regulatory ManagementCompilation of QED decisions on stylistic matters in product information Issues AbbreviationsConnected problems Subscript and
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Compilation of QRD decisions is the process of gathering and organizing all quality review decisions made in a specific time period.
Entities responsible for quality review decisions are required to file compilation of QRD decisions.
Compilation of QRD decisions can be filled out by documenting all decisions made, including details such as dates, outcomes, and any relevant notes.
The purpose of compilation of QRD decisions is to create a record of quality review decisions for review and analysis.
Information such as decision dates, outcomes, any issues identified, and actions taken must be reported on compilation of QRD decisions.
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