Risk Management Services

In today's environment, simple risk communication in the form of product labeling (Package Insert or Summary of Product Characteristics) to meet regulatory needs is often insufficient. Obtaining and maintaining Marketing Authorization for products is becoming increasingly difficult. This is especially true with medicinal products that represent a new molecular entity or a new class of therapy.

PRA's Risk Management Services team provides product life-cycle support from development through commercialization, allowing clear assessment and communication of efficacy and safety.

PRA's Services Include:

• Product life-cycle Pharmacovigilance Plan
• Risk Management Planning
  • Risk Evaluation and Mitigation Strategy (REMS)
  • Risk Management Plan (RMP)
• Product specific Risk Identification, Assessment and Minimization pre- and post-approval
• Benefit-Risk Assessments and Investigation of safety issues
• Communication of safety issues
• Peri- and post-approval Risk Management Programs

Safety & Risk Management works closely with PRA's Late Phase Services to support epidemiological activities. This team is responsible for the design, development and execution of risk management focused Phase IV programs, including:

• Limited or Restricted Access programs
• Product, Disease or Pregnancy Registries
• Observational Studies