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March 2022 EMA/377884/2015Rev.2 Veterinary Medicines Divisionalization checklist for initial MAY immunological (applicable to submissions under Regulation (EU) 2019/6) 1. Background on the product
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Start by gathering relevant data and information about the subject of evaluation.
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Identify the specific trends or patterns that you want to track and analyze in the initial evaluation.
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Trends in initial evaluation refer to the analysis of patterns or tendencies observed during the initial assessment or review of a particular subject or issue.
The party or individual responsible for conducting the initial evaluation is typically required to file trends in initial evaluation.
Trends in initial evaluation can be filled out by recording and analyzing the relevant data or information obtained during the initial assessment process.
The purpose of trends in initial evaluation is to identify and track patterns, changes, or developments over time, which can provide valuable insights for decision-making or planning purposes.
Information such as key findings, trends, challenges, opportunities, and recommendations based on the initial evaluation should be reported in trends in initial evaluation.
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