China PV Services

Accestra Consulting is dedicated to providing China pharmacovigilance (PV) and regulatory consulting services, assisting clients with outsourcing of their pharmacovigilance activities in China.​

China Pharmacovigilance (PV) Services

China Responsible Person for Pharmacovigilance (RPPV) outsourcing

Nomination of Local contact person for Pharmacovigilance in China (RPPV)

China Individual Case Safety Report (ICSR) Handling

  • Call centre service
  • Post marketing ICSR: triage, assessment, MedDRA coding, processing
  • Expedited and SUSAR Reporting
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    China Literature Surveilance: Monitoring & Screening

  • Regulatory Authority Monitoring (CDE and CDR of NMPA)
  • China and International literature screening/monitoring
  • Chinese Literature screening database consulting and membership
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    China Pharmacovigilance Audits and Inspection

  • Gap-analysis audit in China
  • China Pharmacovigilance Audit and inspection preparation
  • Compliance and quality
  • Inspection readiness
  • Quality management system (QMS) development procedures
  • Strategic and tactical audit planning and risk assessment
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    China Pharmacovigilance (PV) System Set-up and Maintenance

  • Pharmacovigilance System Master File (PSMF) Preparation
  • Management Policy and SOP Review
  • Inhouse Safety Databbase
  • PV Agreements
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    China PV Aggregate Reporting

  • Periodic Safety Update Report (PSUR)
  • Development Safety Update Report (DSUR)
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    China Risk Management System (RMS) Operation

  • China Risk Management Plan (RMP) Witing and Counsulting
  • Risk Minimisation Activities Materials Preparation
  • Safety Signal Detection and Management
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    China PV Consulting & Intelligence

  • Regulatory Compliance
  • China Pharmacovigilance Safety Database
  • Client personnel training on Pharmacovigilance and other talor-made training to the client’ s need.
  • Audits and Inspection Training
  • Pharmacovigilance in China Training

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    Pharmacovigilance (PV)