Risk Management

 

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

 

1. Risk Specifications
• Summary of nonclinical and clinical safety
• Presentation of important identified or potential risks
• Review of relevant epidemiology data for important risks
• Important missing information or other safety concerns


2. Strategy for PV Plan and Risk Minimization Plan
• Routine PV activities
• Additional studies for risk evaluation
• Routine risk minimization activities
• Additional risk minimization activities
• A proactive and integrative risk management strategy cumulating into a credible Risk Management plan


3. 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)


4. 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

G2 Strengths

  • US Based
  • 24/7 coverage
  • Safety expertise
  • Cost effective
  • Teamwork
  • Compliance-focused
  • Quality-driven
  • Timely turn-around
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