News



May 03, 2017

On April 26-28, 2017, the Directorate of Distribution Control of Therapeutic Product and Household Medical Supplies held again The Improvement of Pharmacovigilance Competence for Pharmaceutical Industry.  Previously, this activity was conducted regularly every 2 (two) years, but considering the need for the NADFC’s assistance to the implementation of pharmacovigilance in the Pharmaceutical Industry, this year the activity to increase this competence was carried out again.


With the material provision during the activity, it was expected that such personnel can have the competence and capability in the field of pharmacovigilance, so as to be able to initiate and manage the pharmacovigilance system in their respective Industries.  The material presented also included how to evaluate and have analytical sharpness in monitoring the implementation of pharmacovigilance in the Pharmaceutical Industry.


The Improvement of Pharmacovigilance Competence for Pharmaceutical Industry was attended by 53 (fifty-three) participants consisting of 41 (forty-one) people from Pharmaceutical Industry, 2 (two) people from the Provincial Office of NADFC in Surabaya and 10 people from the NADFC.


As the lecturer in this activity were dr. Jarir At Thobari, PhD (the academic lecturer of the Faculty of Medicine, Gadjah Mada University), who gave the introduction of scientific pharmacovigilance, Mr. Masahiko Yokota, who delivered "Pharmacovigilance System in Japan," as well as The Implementation of Pharmacovigilance in the Pharmaceutical Industry" by pharmacovigilance practitioners in the Pharmaceutical Industry.


The lecturer from the NADFC were Head of Subdirectorate of Surveillance and Risk Analysis of Therapeutic Products and Household Medical Supplies, who conveyed about "Guidelines for the Implementation of Pharmacovigilance in Pharmaceutical Industry, Overview of Pharmacovigilance Guidelines and Pharmacovigilance Implementation Monitoring Tools in Pharmaceutical Industry."  It was also delivered "Introduction of e-MESO (Monitoring Drug Side Effects) Sub site and Reporting Side Effects of Drugs Electronically" by Section Head of Therapeutic Products Surveillance and Household Medical Supplies.


In the closing remarks, the Director of Distribution Control of Therapeutic Product and Household Medical Supplies, Drs. H.G. Kakerissa, Apt stated that in the future, the implementation of pharmacovigilance would be monitored by the NADFC by doing inspection on the pharmacovigilance of Pharmaceutical Industry gradually and would follow up the pharmacovigilance systems in Pharmaceutical Industry. (mda)




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