NextPV Services

Services

Everything we do, we do with the aim to elevate the science of pharmacovigilance and make the patient and drug safety a seamless endeavour.

NextPV Services covers the full spectrum of PV services including the strategic advice, PV system designing and implementation, outsourcing of all PV processes, EU QPPV and EU local QP network. We also provide audits, gap analysis and trainings.

Global, EU and local QPPV services
  • EU QPPV and Deputy EU QPPV services
  • European Network of Local QPPVs/Local contact persons
  • Regulatory Intelligence
PV systems
  • Full PV system outsourcing
  • Gap analysis and audits
  • PSMF and QMS development and maintenance
PV Automation
  • Advice and implementation of AI powered tools for your organisation. Hands-on experience with variety of currently available tools (areas of ICSR/case processing, signal management, literature screening)
EudraVigilance (EV) and eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)
  • EV registration, setup and maintenance
  • Advice on ISO IDMP implementation
Signal and Benefit/Risk Management
  • RMP design, writing and submission including additional risk minimisation measures for innovative, orphan or any other product types
  • EVDAS
  • Signal management - process design, quantitative analysis and scientific advise
Pre-marketing safety
  • Setup/review of PV activities for Sponsors including preparation of Safety Management Plans
  • Advice on EU clinical trial regulation (CTR) implementation including operation of new CTIS portal
Audits
  • PV system audits, gap analysis, support during audits/inspections
  • Inspection/audit readiness support and training
PV Trainings
  • GVP trainings (complete GVP modules training available)
  • Any other PV activities focused trainings (e.g., Signal Management, ICSR Management, EU QPPV)
Safety Database
  • Safety database setup/maintenance, including validation
ICSR/case management
  • End to end ICSR management, including expedited reporting to health authorities
  • Expert advice on the whole process and its optimization
Medical writing
  • Preparation of PSURs/PBRERs, RMPs, DSURs, ACO

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