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 — we adhere to three-yearly audits.
Talk to our PV teamPV services at a glance
PV mailbox: pharmacovigilance@mpca.be
Our pharmacovigilance services in detail
Safety Data Management
From collection and translations to data entry, quality control, medical review, regulatory submission and case follow-up — we manage your safety data and meet all ICSR requirements.
ICSR Management
Full support for each step of the ICSR handling process — MedDRA and WHO drug coding, case assessment, proactive case follow-up and electronic case submission to EMA.
Literature Monitoring
Weekly global and local literature monitoring for the Benelux. We search local medical journals in Belgium, the Netherlands and Luxembourg for safety-relevant information.
Signal Detection & Risk Management
We manage the signal detection and benefit-risk profile of all marketed medicinal products. Drug Safety Committee meetings keep you informed and involved at agreed intervals.
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 update it throughout your product lifecycle.
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.
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.