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This news article is related to:
This news article is related to:
Pharmacovigilance Award
National Agency of Drug and Food Control, Indonesia
2018

October 30, 2018, 01.19 pm

Dexa Medica Received Notable Recognition for Its Pharmacovigilance

Dexa Medica again received an award from the government. The award that was obtained this time was Pharmacovigilance in the category of Domestic Capital Company, which was presented by the Head of the National Food and Drug Agency Mrs. Penny Lukito to the Director of Scientific and Business Development Dexa Medica Mr. Raymond Tjandrawinata, in the Workshop on “Effectiveness of Drug and Food Control”. Through Synergy with Business Actors” at Hotel Arya Duta Bandung, 30 October 2018.

The Pharmacovigilance award ceremony was also attended by Manager, Risk Management and Clinical Review, Mrs. Dwi Nofiarny and Head of Corporate Communications Dexa Group, Mr. Sonny Himawan. The Pharmacovigilance Award from BPOM RI is an award given to Dexa Medica for its achievement as a pharmaceutical industry that has good compliance in conducting drug safety supervision (pharmacovigilance). The implementation of pharmacovigilance for the pharmaceutical industry has been implemented in accordance with the Regulation of the Head of the Indonesian Food and Drug Supervisory Agency Number HK.03.1.23.12.11.10690 of 2011. In this case, Dexa Medica has implemented pharmacovigilance activities since 2003 or long before the regulation came into effect.

According to applicable legal regulations, reporting on pharmacovigilance activities consists of spontaneous reporting, post-marketing periodicals, post-marketing safety studies, scientific publications/literature, the regulatory follow-up to other country’s regulatory authorities, the follow-up to marketing permit holders in other countries, and or reporting from risk management planning.

Based on data held by BPOM, since the issuance of regulations regarding Pharmacovigilance, there has been an increase in the number of reports of Unwanted Events/Drug Side Effects (ESO) from health workers and the pharmaceutical industry in Indonesia every year. The results of data analysis of the Directorate of Safety, Quality, and Export-Import of Drugs, Psychotropic Narcotics, Precursors and Addictive Substances were conducted in March 2018, out of a total of 206 pharmaceutical industries in Indonesia, there are 105 industries that have reported pharmacovigilance to BPOM.

“The health sector is a strategic economic driver including food, medicine, and traditional medicine, as well as supplements that we must increase the effectiveness of its use. This is in accordance with BPOM’s commitment to implementing the 5th Nawacita, namely improving the quality of human life and the 7th about realizing economic independence by moving strategic sectors of the economy, “said Mrs. Penny.

For this compliance, PT Dexa Medica is one of the companies that received the Pharmacovigilance award because it is considered very active in carrying out pharmacovigilance activities. Mr. Raymond Tjandrawinata said that this award is proof that Dexa always adheres to the practice of complying with the regulations of the pharmaceutical industry in Indonesia.

“Pharmacovigilance is very important for the pharmaceutical practice to support quality and patient safety. Dexa always prioritizes these two essential aspects according to the mandate of the founder of Dexa Medica, Mr. Rudy Soetikno. In this case, the Dexa Group pharmacovigilance team has become a BPOM partner and has even become a resource person for every BPOM activity related to pharmacovigilance regulations,” explained Mr. Raymond. Corporate Communications Dexa Medica