The RMP gives data about the observed risks, potential risks, and any missing data as well as a description of the risk management process.
The RMP gives data about the observed risks, potential risks, and any missing data as well as a description of the risk management process. This plan also describes any risk-reduction strategies that were implemented and provides details on how their efficacy is being measured and monitored.
The risk management plans must be submitted with all new pharmaceutical product applications to the applicable regulatory agencies as part of Module 1 of CTD (1.8.2).
We can assist sponsors with creation and updation of the RMP and Risk Evaluation and Mitigation Strategy (REMS) to support the marketing authorization applications by using the appropriate tools, processes, knowledge, and insight.
PVG Pharmasciences is looking for variety of roles, and talented individuals to join oir team
Drop your CV at info@pvgpharmasciences.com
