An overview of managing safety concerns in the DSURs, RMPs and PBRERs
An overview of managing safety concerns in the DSURs, RMPs and PBRERs What are safety concerns? ICH defines safety concern as an important identified risk, important potential risk or missing information (GVP Annex IV, ICH-E2C(R2) Guideline). An important identified and potential risk could have an impact on the risk-benefit balance of the product [...]