Expert Pharmacovigilance Services for the Benelux & EU
Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce their risks and increase their benefits. M.P.C.A. International provides both global and local PV services, acting as your EU QPPV or Local Contact Person for the Benelux.
Complete pharmacovigilance support
M.P.C.A. International can implement a complete pharmacovigilance system into your company and act as EU QPPV or Local Contact Person for Benelux, with full access to medical evaluation.
Alternatively, we can be responsible for parts of your pharmacovigilance system, or act as the Deputy QPPV or Deputy of the Local Contact Person / Local Safety Officer.
Our PV staff is fully and continuously trained following a yearly training plan. We are open to any assessment and external audit from your site and we adhere to three-yearly audits.
Do any of these questions apply to you?
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Do you need a QPPV or a deputy QPPV for the EU or the BENELUX?
M.P.C.A. International provides an EU QPPV, deputy EU QPPV and Local Contact Person (LCP and Deputy LCP) for the BENELUX, with full access to medical evaluation. We can run your complete pharmacovigilance system or act as back-up for your own team.
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Is your Pharmacovigilance System Master File inspection ready?
We build and maintain your Pharmacovigilance System Master File (PSMF) and keep it permanently inspection ready. Our PV staff is fully and continuously trained following a yearly training plan, and we adhere to three-yearly external audits.
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Would you like to outsource ICSR processing and literature monitoring?
We take over ICSR processing, MedDRA coding and global and local literature monitoring for your products. Cases are processed within GVP timelines and reported to EudraVigilance.
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Do you need support with signal detection and risk management?
Our team performs signal detection and manages risk management plans and periodic safety reports for your products. You get documented, GVP-compliant safety oversight without having to build that capacity in-house.
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Are you preparing for a pharmacovigilance inspection or audit?
We prepare your team and your documentation for pharmacovigilance inspections and audits, and as your PV provider we are open to any assessment and external audit from your side.
If you answered yes to any of these, our pharmacovigilance team can help.
Talk to our PV teamPV services at a glance
PV mailbox: pharmacovigilance@mpca.be
Our pharmacovigilance services in detail
PSMF Management
Your Pharmacovigilance System Master File is crucial. Every MAH must have a PSMF in place. We maintain it, ensure it is audit-ready, and maintain it throughout your product lifecycle with an updated quality management system (QMS PV SOPs).
Safety Data Management (ICSR)
We manage your safety data and meet all ICSR requirements. Full support for each step of the ICSR handling process: from collection and translations to MedDRA and WHO drug coding, case assessment with quality control, medical review, proactive case follow-up and validated electronic case submission to EMA.
XEVMPD (Extended EudraVigilance Medicinal Product Dictionary)
We manage the mandatory European database (Article 57 database) for submitting and managing information on your authorized and investigational medicinal products.
Signal Detection & Risk Management
We manage the signal detection and benefit-risk profile of all your marketed medicinal products. Drug Safety Committee meetings keep you informed and involved at agreed intervals.
Literature Monitoring
Weekly global (worldwide) and local literature monitoring for the Benelux. We search local medical journals in Belgium, The Netherlands and Luxembourg for safety-relevant information.
Safety Physician Services
Our safety physicians are ready to support medical reviews of SUSARs and ICSRs, signal validation, aggregate reports, RMP and aRMM, across a wide range of therapeutic areas.
Pharmacovigilance services
What is pharmacovigilance and why is it required?
What is an EU QPPV and do you provide one?
What is a Local Contact Person for pharmacovigilance?
Which pharmacovigilance tasks can M.P.C.A. take care of?
How do I set up a pharmacovigilance system with M.P.C.A. International?
Need a QPPV or pharmacovigilance system?
Our pharmacovigilance team is ready to implement a complete PV system for your company or act as your EU QPPV, ensuring full compliance and patient safety.