This is where all are put into perspective and further actions that may go beyond safety are determined. We thoughtfully assess safety signals and risks from the most appropriate medical and regulatory perspective that maximizes benefit risk balance. In this context the specific aspects may include:

• Communication strategies
• Population stratification
• Strength of association
• Public health significance
• “Know what you don’t know”
• Specific interventions
• Ongoing monitoring and modifications based on effectiveness

You can rely on our support to make sure that the safety issues are communicated and the available tools are used properly and effectively. We can review and provide quality content to documents and processes that may include:

• Safety issue escalation plans (see below)
• RMPs, RiskMAPs, REMS, and other submission documents
• Pharmacovigilance plans
• Clinical study reports
• Expert consultation