Risk Management and Pharmacovigilance Planning

At the core of PPD’s pharmacovigilance and risk management services is a life-cycle approach to risk-benefit identification and assessment. PPD specializes in post-approval strategies and offers pharmacovigilance planning services, including development of safety specifications. Our experts also provide development, implementation and evaluation of risk minimization action plans (RiskMAPs).

Services

PPD’s systematic approach to risk management helps increase benefits and reduces therapeutic risks. Our services include:

• Risk identification and assessment
• Risk communication
• Interventions to reduce risk
• Evaluation of intervention effectiveness
• Modification of interventions when needed

PPD understands that a risk-benefit profile evolves over a drug’s life cycle and does not end at approval.

Post-Approval Assessment

In the post-approval setting where new data are continuously available, our pharmacovigilance planning services allow for the ongoing reassessment of risk and benefit over a drug’s life cycle. PPD provides risk assessment and risk minimization to keep your product on the market.

Post-approval assessment of risk is especially important given the limitations of pre-marketing clinical trials. By creating definitions of risk management and specifying risk minimization action plans that go beyond package insert and routine post-approval surveillance, the FDA has also made focus on formal risk management policies imperative.