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

Life Sciences

Medical Devices

Pharmaceutical

NextPV Services

NextPV Services' headquarters in Prague 3, Czech Republic

Description

People (1)

Jan Kolouch

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