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Pharmacovigilance Services in Colombia

The Colombian National Food and Drug Surveillance Institute (INVIMA) is responsible for overseeing all regulatory and pharmacovigilance services for pharmaceutical products that are in circulation in the country. Patient safety is the core of all pharmacovigilance activities where timely detection and management of ADRs is imperative in order to implement effective risk mitigation/minimization strategies. The INVIMA mandates all manufacturers and marketing authorization holders (MAHs) to report ADRs and any product-quality related issues to determine the safety profile of the pharmaceutical product.Colombia is actively working to improve their pharmacovigilance services in Colombia by enhancing the quality and quantity of ADR reports by, for example, implementing electronic ADR/AE submission tools and expanding their National Pharmacovigilance Network. As a result, a significant increase was seen in the number of reported ADRs and originated from a variety of regions within Colombia. However there are still important pharmacovigilance parameters that require proactivity to ensure patient safety. 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 post-market surveillance.

As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Colombia that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development 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 monitoring & 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 documents – i.e Prescribing Information & Medical Guides

Aggregate Reports

  • Periodic Adverse Drug Experience Reports (PADERs)
  • 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, pharmacovigilance aggregate reporting as well as regulatory agency website monitoring
  • Utilizes a variety of in-house tools and databases for signal detection and tracking safety signal monitoring
  • 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.

QPPV Services

  • Authoring/Review of SDEA agreements, agreements with commercial partners, PV SOPs etc.
  • Monthly reconciliation
  • Medical review of Signal detection; Signal Surveillance Meetings (Quarterly)
  • Monthly Communication report/provision of compliance metrics
  • PV Quality Management System Oversight

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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