Pharmacovigilance Services in Colombia

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Colombia, access to pharmacovigilance services in Colombia is critical to ensuring drug safety and regulatory compliance.From adverse drug reaction(ADR) reporting to compliance with INVIMA pharmacovigilance regulations, the right PV partner shapes everything: signal detection, risk management planning, safety reporting, and successful market authorization.

Expert Pharmacovigilance Services for the Colombia Market

The Colombian National Food and Drug Surveillance Institute (INVIMA) is the national regulatory authority overseeing all pharmacovigilance consulting services in Colombia. It monitors all pharmaceutical products in circulation, mandates reporting of ADRs and product-quality issues by manufacturers and Marketing Authorization Holders (MAHs), in order to continuously determine and update the safety profile of medicinal products. Patient safety is at the core of pharmacovigilance, where timely detection and management of ADRs is imperative for effective risk mitigation/minimization strategies.

The Colombian National Food and Drug Surveillance Institute (INVIMA) is the national regulatory authority overseeing all pharmacovigilance consulting services in Colombia. It monitors all pharmaceutical products in circulation, mandates reporting of ADRs and product-quality issues by manufacturers and Marketing Authorization Holders (MAHs), in order to continuously determine and update the safety profile of medicinal products. Patient safety is at the core of pharmacovigilance, where timely detection and management of ADRs is imperative for effective risk mitigation/minimization strategies.

As a leading pharmacovigilance consultant Colombia and global safety partner, DDReg understands the significance of patient safety across the full lifecycle of medicinal products, from clinical trials through post - marketing surveillance.Our drug safety services portfolio includes end - to - end pharmacovigilance services in Colombia that cover:

• Adverse drug reaction reporting (initial, follow-ups)
• Signal detection & management
• Aggregate report writing
• Development of customized pharmacovigilance plans / risk management plans (RMPs) in accordance with local requirements and good pharmacovigilance practices
• Consulting on global best-practices adapted to Colombian regulatory expectations

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs, SUSARs
  • Case processing through E2B(R3)-compliant databases and other relevant databases integrated with WHODrug and MedDRA / WHO Drug Dictionary
  • Quality checks and medical reviews
  • Submission of cases as per INVIMA timelines
  • Maintaining ICSR monitoring & tracking sheets
  • Reconciliation process with customers
• + Risk Management Plan(RMP)
  • Drafting, reviewing, and maintaining risk management and risk minimization procedures in alignment with INVIMA requirements
  • Preparing customized procedures to classify safety risks and deliver tailored risk management strategies
  • Assessment of potential risks and missing information; preparing reports recommending risk management methods
  • Implementation of supplementary measures including Post-Authorization Safety Studies (PASS), observational examinations, follow-up questionnaires
  • Effectively convey risks through labelling documents – prescribing information & patient/medical guides
• + Aggregate Reports
  • Periodic Adverse Drug Experience Reports (PADERs) or equivalent Colombian periodic safety reports
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)
• + Signal Management
  • Identification of new safety signals and/or changes in risks from ICSRs, literature, regulatory agency website monitoring, aggregate reports
  • Use of in-house tools and databases for signal detection and tracking
  • Review of signals and recommendations by Pharmacovigilance committees or equivalent oversight bodies
  • Label update analysis
  • Preparation of signal management trackers and annual signal reports
• + QPPV / Local Person Responsible & Governance
  • Authoring/review of SDEA (Safety Data Exchange Agreements), agreements with commercial partners, PV SOPs, etc.
  • Monthly reconciliation and compliance metrics reporting
  • Medical review of signal detection; holding Signal Surveillance Meetings (quarterly)
  • Oversight of pharmacovigilance Quality Management System (QM / QMS)
• + PV Audit & Compliance
  • Review and ensure compliance to applicable PV guidelines, regulations, SDEAs, SOPs, and work instructions relevant in Colombia
  • Develop audit plans and conduct mock audits to prepare for INVIMA inspections
  • Conduct regular gap assessments of PV staff at site
  • Provide organizational training on safety PV audits and inspections