Pharmacovigilance - Colombia

Pharmacovigilance

Pharmacovigilance are all activities related to the detection, evaluation, understanding and prevention of adverse events or problems related to medicines. It is essential to determine the safety profile of marketed drugs, to detect adverse reactions, inappropriate uses, therapeutic failures and other complications not evidenced during the drug research stage.

Colombia has the National Pharmacovigilance Program led by INVIMA with the objective of monitoring the safety, effectiveness and quality of medicines in the commercialization stage and includes the participation of all the actors involved in the medicine’s life cycle: patients , relatives, treating physicians, pharmacists, clinics and hospitals, secretariats of health and pharmaceutical laboratories.

At Aruna Asesores, we have a Pharmacovigilance unit with highly trained professionals in advising, analyzing and training matters related to drug and patient safety, focused on the pharmaceutical and hospital industry, all of this in compliance with Colombian regulations. offering the following services:

  • Problems related to drugs in the post-marketing phase (chemical synthesis, biological and phytotherapeutic)
  • Identification of problems related to investigational drugs
  • Management analysis of adverse event reports
  • Identification of signs and medication errors
  • Analysis and evaluation of causality
  • Traceability of the adverse event
  • High risk medications
  • LASA drugs
  • Training for the sales force in the pharmaceutical industry.
  • Training of the hospital population
  • Advice on research projects related to the area of pharmacovigilance

Check with our professionals online or get frequent questions about registration processes in different countries

Check with our professionals online or get frequent questions about registration processes in different countries