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About NextPV 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. Contact us via info@nextpvservices.com. We offer a wide range of expert services with focus on the following: QPPV services -EU QPPV and Deputy EU QPPV services, Global QPPV support/advice -Local QPPV/Local contact person for pharmacovigilance services/management PV systems -Full PV system outsourcing, including all required PV activities -Review of current system with proposals for improvements -PSMF development and maintenance -Development of company’s quality management system, including Standard Operating Procedures (SOPs), Working Instructions (WI), Policies etc. Artificial intelligence -Advice and support on Artificial Intelligence 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 -Setup, review and optimization of signal management for your organisation -EVDAS advice, support and implementation for your organisation -Additional Risk Minimisation measures advice for your products 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 Managemenet, 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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