Safety report is a collection of Vigilance data that helps competent authorities and NBs in determining the risk-benefit ratio of a medicinal product concerning the global safety norms. The data collected through these reports help both patients and healthcare professionals in retrieving the necessary updates.
For different countries, based on risk classification, reporting period changes. Coming to the content of these reports, there’s lot of overlap between different countries. So not just doing individual reports, MakroCare has standardized templates that can be used across countries and get synergies well to save time and costs
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