Risk Management

Our safety team shines in dealing with risk management of drug safety and pharmacovigilance.

Risk Specifications

  • Summarizing of nonclinical and clinical safety
  • Presentation of important identified or potential risks
  • Review of relevant epidemiology data for important risks
  • Finding important missing information or other safety concerns

Strategy for PV Plan and Risk Minimization Plan

  • Routine PV activities
  • Additional studies for risk evaluation
  • Routine risk minimization activities
  • Additional risk minimization activities
  • Following a proactive and integrative risk management strategy culminating in a credible Risk Management plan

Pre-approval risk assessment

  • Disease epidemiology review (e.g., nature history, prevalence, characteristics and patterns of disease severity and impact)
  • Proactive risk monitoring and signal detection in clinical trials
  • Integrated review of safety data from clinical pharmacology studies, randomized trials, and large simple safety study
  • Ongoing evidence-based risk/benefit assessment
  • Safety related amendment or updates (e.g., IB, ICF, SAP, DMP, SMP, MMP)

Post-marketing PV & Risk Management

  • Development of EU-RMP and risk monitoring approaches (e.g., Annex 1 for EU Vigilance Databases)
  • Designing US REMS, RiskMAP
  • Customized approaches for risk-specific assessment and risk minimization
  • RMP related PV activities: PSUR, PBRER, CCDS/product labeling update, safety studies, overall assessment of benefit/risk balance