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KMID : 1011320090020020075
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Journal of Pharmacoepidemiology and Risk Management
2009 Volume.2 No. 2 p.75 ~ p.77
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Responsibilities of Pharmaceutical Industry on Pharmacovigilance and Risk Management
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Choi Seong-Choon
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Abstract
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The responsibility for pharmacovigilance and risk management of pharmaceutical products is critical at this moment. Recently Korean Pharmacovigilance Corporation was established, still some stakeholders did not understand the importance of pharmaceutical industry to manage the issues of pharmacovigilance and risk management. The details of the responsibility in pharmaceutical companies are 1) the main party for the management of regulatory Postmarketing Surveillance (PMS) based on Reexamination, 2) management of spontaneous adverse event reporting and development of enhancement for the better reports, 3) key role in the development and submission of postmarketing pharmacovigilance planning and risk management for pharmaceutical products, 4) one of the stakeholders to capture and analyze the signals and to reflect the label through collaboration with Health Authority. So pharmaceutical companies have the greater role to promote pharamacovigilance related activities in Korea. In this article, some proposals to Korean Pharmacovigilance Corporation will be included.
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KEYWORD
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Pharmacovigilance, Risk management, Postmarketing surveillance, Signal
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