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RMP OneScope™ Process
RMP OneScope™

Integrated Risk Management System

RMP OneScope™

From Safety Data collection to risk-based RMP planning, execution, and regulatory response, the RMP OneScope™ service enables unified, integrated post-marketing safety management.

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The re-examination system has been discontinued, and all post-marketing safety activities now begin with the RMP.

RMP OneScope™ Process

A

Routine
PV Activity

  • Literature Monitoring
  • Signal/Risk Monitoring
  • ICSR Reporting
  • PV System Set-up
  • RMPPBRER

Routine PV activities such as literature monitoring and ICSR reporting, through which safety data are collected to support risk management.

RISK
CENTRIC
B

Post Marketing
Surveillance

  • PMS
  • RWD
  • OS
  • NIS

Post-marketing studies, including PMS and RWD research, that generate the safety data required for continuous risk management.

C

Risk Minimization

Product
InformationEducation
ProgramEducation
MaterialControl
Access ProgramPPP

Routine PV activities such as literature monitoring and ICSR reporting, through which safety data are collected to support risk management.

Leveraging artificial intelligence (AI) and digital technologies for PV systems and RWD research.

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