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 cover the full spectrum of PV services including the strategical advice, PV system designing and implementation, outsourcing of all PV processes, EU local QP network and the EU QPPV role. We provide audits, gap analysis and training.

Global, EU and local QPPV services

  • EU QPPV and Deputy EU QPPV services
  • European Network of Local QPPVs/Local contact persons
  • Local RA network

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

Contact us

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