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The Improvement of Pharmacovigilance Competence for Pharmaceutical Industry is an activity that is conducted regularly every 2 years.  In 2016, this activity was held at Golden Boutique Hotel on September 14-16, 2016.


This activity aims to provide knowledge in the field of pharmacovigilance for the pharmaceutical industry to improve the competence of human resources (personnel) who handle pharmacovigilance.  The personnel are expected to have competence and capability in the field of pharmacovigilance including understanding regulations related to pharmacovigilance, being able to initiate and manage the pharmacovigilance system in their respective Industries.  In addition, the personnel are expected to be able to evaluate and have analytical sharpness in monitoring the implementation of pharmacovigilance in the Pharmaceutical Industry, as well as fulfilling its obligations under applicable regulations.


This activity was officially opened by the Acting Deputy to Therapeutic and Drug Products Supervision, Drs. Ondri Dwi Sampurno, MSi., Apt.  In his opening remark, the Acting Deputy hoped that the pharmaceutical industry would take advantage of this training opportunity as well as possible and build a strong commitment to the implementation of good pharmacovigilance in the role and responsibility of the pharmaceutical industry in ensuring the safety of drug products that were circulated.


The Improvement of Pharmacovigilance Competence for Pharmaceutical Industry was attended by 147 participants consisting of 122 people from Pharmaceutical Industry, 1 person from Directorate of Pharmaceutical Services-Ministry of Health of the Republic of Indonesia and 24 people from the NADFC.


In this activity the participants got the material "Basic Pharmacovigilance" from the academic lecturer of the Faculty of Medicine, Gadjah Mada University (dr. Jarir At Thobari, PhD).  Two other materials on "Drug Interactions" and "Allergic Reactions and Stevens Johnson syndrome" were provided by academic lecturer from the Faculty of Medicine, University of Indonesia (Dr. Suharti K. Suherman, SpFK and Dr. Nafrialdi, SpPD). On this occasion, there was a sharing of "Pharmacovigilance System in Japan" by Mr. Masahiko Yokota and "Implementation of Pharmacovigilance in the Pharmaceutical Industry" by pharmacovigilance practitioners in the pharmaceutical industry.


The speakers from the NADFC were Siti Asfijah Abdoellah, SSi., Apt., M.MedSc. as Section Head of Surveillance and Analysis of Therapeutic Products Risk and Household Medical Supplies also talked about "Guidelines for Implementation of Pharmacovigilance in Pharmaceutical Industry, Overview of Pharmacovigilance Guidelines, and Pharmacovigilance Implementation Monitoring Tools in Pharmaceutical Industry."  Reporting drug side effects electronically through the e-MESO website is also presented in this activity by the Section Head of Therapeutic Products and Household Medical Supplies.  Electronic reporting is expected to facilitate and increase the role of the pharmaceutical industry and healthcare professionals in reporting the side effects of drugs to the NADFC. (rdh)

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