Pharmacovigilance services in Belgium

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Belgium, explore DDReg’s pharmacovigilance services in Belgium to ensure drug safety and regulatory compliance. From adverse drug reaction reporting to compliance with Belgium pharmacovigilance guidelines, the right PV partner shapes everything: signal detection, risk management planning, safety reporting, and successful market authorization.

Expert Pharmacovigilance Services for the Belgium Market

The Belgian Centre for Pharmacovigilance (BCPH), part of the Federal Agency for Medicines and Health Products (FAMHP), is responsible for coordinating Pharmacovigilance Services Provider in Belgium tasks. This includes collecting and evaluating periodic safety reports, safety data during clinical trials of medicines to be authorised in Belgium, and individual reports about undesirable reactions submitted by healthcare professionals and marketing authorisation holders (MAHs). BCPH also oversees pharmacovigilance inspections to prevent and mitigate risk and evaluates risk management plans and pharmacovigilance systems. Healthcare professionals can report ADRs (adverse drug reactions) using the yellow card form by post or submit ADRs online. The mutual recognition of quality via quality labels is essential so that competent medicines authorities within the European Union (EU) can trust each other. The MAHs must appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) to oversee and coordinate pharmacovigilance activities. If the QPPV is not located in Belgium, the MAH must appoint a local contact person for Belgium and inform the FAMHP. This includes better ADR analysis methods and simplifying ADR reporting procedures to make them more user-friendly, thereby encouraging all relevant stakeholders to report ADRs, strengthening the quality system and improving risk management.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case processing through E2B(R3)-compliant databases and integration with WHO DD and MedDRA dictionaries
  • Quality check, medical reviews
  • Submission of cases according to FAMHP / EU timelines
  • Maintaining ICSR tracking sheets, reconciliation with customers
• + Risk Management Plan (RMP)
  • Drafting, reviewing, and maintaining RMPs and any REMS-equivalent while supporting submission methods
  • Custom procedures to classify safety risks and deliver tailored risk management strategies
  • Assessment of potential risks and missing information; preparation of reports recommending risk minimization
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS) (e.g. observational studies, follow-up questionnaires)
  • Conveying risks via labelling (Summary of Product Characteristics (SmPC)), Patient Information Leaflet (PIL)
• + Aggregate Reports
  • Periodic Safety Update Reports (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Identification of new safety signals or changes in risks from ICSRs, aggregate reports, literature, regulatory website monitoring
  • Use of in-house tools and databases for signal detection and tracking
  • Review of safety signals and recommendations by Pharmacovigilance Risk Assessment Committee (PRAC) or equivalent
  • Label update analysis; preparing signal management tracker, annual signal reports
• + QPPV / Local Person Responsible & Governance
  • Review of Pharmacovigilance System Master File (PSMF), Safety Data Exchange Agreements (SDEAs), SOPs etc.
  • Retainer services for QPPV and deputy; providing local safety contact if QPPV is not in Belgium
  • Oversight of PV Quality Management System; medical review of signal detection; periodic communication and compliance metrics
• + PV Audit & Compliance
  • Audit plans, mock audits to prepare organizations for inspections by FAMHP
  • Gap assessments of PV staff and systems
  • Training on safety PV audits and inspections