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Pharmacovigilance services in Belgium

The Belgian Centre for Pharmacovigilance (BCPH) is responsible for coordinating various pharmacovigilance Services in Belgium. BCPH is part of a European network of pharmacovigilance, called EudraVigilance. BCPH is responsible for collecting and evaluating: periodic pharmacovigilance reports, patient safety data during clinical trials involving medicines to be authorized in Belgium, individual reports about undesirable reactions submitted by healthcare professionals and marketing authorization holders (MAHs). It is also responsible for overseeing pharmacovigilance inspections to prevent & mitigate risk and evaluate risk management plans and pharmacovigilance Services Health professionals can report ADRs by filling in the yellow card and sending it by post, or they can also submit an ADR online. The mutual recognition of quality based on quality labels is essential to allow competent medicines authorities within the European Union (EU) to put confidence in each other. The Federal Agency for Medicines and Health Products (FAHMP) works with a Total Quality Management system (TQM). MAHs should appoint Qualified Person in Pharmacovigilance (QPPV) to oversee and coordinate the 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 to strengthen quality system and improve risk management.

As a leading global contender, DDReg understands the significance of patient safety right from spontaneous to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Belgium, including adverse drug reaction reporting, signal detection & management, aggregate report writing, and of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.

DDReg pharmacovigilance Services portfolio include:

ICSR Processing and Submission

  • Triage of initial and follow-up ICSRs, SUSARs,
  • Case Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
  • Quality Check, Medical reviews
  • Submission of cases as per agency timelines
  • Maintaining ICSR Processing & tracking sheets
  • Reconciliation process with customers

Risk Management Plan

  • Drafting, reviewing, and maintaining REMS while providing support through submission methods
  • Preparing customized procedures to classify safety risks and deliver tailored risk management strategies
  • Assessment of potential risks and missing information and prepare reports that recommend risk management methods
  • Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
  • Effectively convey risks through labelling means such as Summary of Product Characteristics (SmPC) and patient information leaflet (PIL)

Aggregate Reports

  • Periodic Safety Update Report (PSURs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)

Signal Management

  • Identification new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, aggregate reports as well as regulatory agency website monitoring.
  • Utilizes a variety of in-house tools and databases for signal detection and tracking signal management processes
  • Reviews safety signals for ICSRs, aggregate reports and recommendations by Pharmacovigilance Risk Assessment Committee (PRAC)
  • Performs label update analysis
  • Provide recommendations from signal assessments which include risk minimization approaches
  • Preparation of Signal Management Tracker, Annual Signal Reports.

Responsible Person for Pharmacovigilance (RPPV)/QPPV Services

  • Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etc
  • Review & sign off of Aggregate reports, Signal Reports and RMPs
  • Retainer services for QPPV and Deputy
  • Local Safety Responsible
  • PV Quality Management System Oversight
  • Monthly reconciliation
  • Medical review of Signal detection; Signal Surveillance Meetings (Quarterly)
  • Monthly Communication report/provision of compliance metrics

PV Audit & Compliance

  • Review compliance audit to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (standard operating procedures) and work instructions
  • Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
  • Conduct regular gap assessments of PV staff at site location
  • Provide organizational training on safety audits and inspections
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