Risk management services

Ashfield Pharmacovigilance physicians and safety experts are critical to the accurate and efficient clinical safety and pharmacovigilance programs we provide you. Our medical professionals ensure that all of your safety surveillance activities are conducted to the highest medical, ethical and safety standards.

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Ashfield Pharmacovigilance’s Risk Management Services include:

  • Development of RMPs

  • Pharmacovigilance plans

  • Reference safety information reviews/revisions (e.g. core label, SPC, PI, CIB)

  • Annual and ad hoc safety signal evaluations

  • Medical assessment and analysis for Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER) and Periodic ADE Report (PADER)

  • Position papers

  • Health hazard analysis

  • Medical monitoring

  • Case narrative company assessment/clinical evaluation comments

  • Causality assessments

  • Risk benefit assessments

  • Analysis of Similar Events (AOSE)

  • Integrated Summary of Safety Sections (ISS)

  • NDA annual report safety sections

  • Product expectedness lists

  • Development of innovative pharmacovigilance interventions to proactively identify, characterize and prevent risks

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