|
KMID : 1011320140070010007
|
|
Journal of Pharmacoepidemiology and Risk Management
2014 Volume.7 No. 1 p.7 ~ p.16
|
|
|
Roles of Responsible Person for Pharmacovilance: Introducing Domestic, Foreign Regulations and Competency Reinforcement Strategy
|
|
Kim Je-Yon
Seong Jong-Mi
Ahn So-Hyeon
Jung Soo-Youn
Park Byung-Joo
|
|
|
Abstract
|
|
|
|
Increase in the use of medicine exposes patients to unexpected risk. So as public concerns rise over drug safety, pharmacovigilance activities have become important for pharmaceutical companies. In the regulatory perspective, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have been granted significant additional legal authority over postmarketing and pharmacovigilance activities in their regions. To strengthen the pharmacovigilance system in pharmaceutical companies, Korea also implemented new rules and regulation of designating ‘Responsible person for pharmacovigilance (RPPV)’ since 2007, who oversees the overall drug safety of their products. However, the implementation of regulation of RPPV is still in its early stage and more clarification of their role and the needs for structured education have been raised. The objective of this study is to compare the laws and regulations governing person responsible for pharmacovigilance in EU, US, Japan and Korea, and the manner in which regulatory agencies approach the imperative for education. Moreover, this study aims to draw up a strategy to reinforce competencies of those involved in pharmacovigilance by introducing a conceptual framework. For the improvement of RPPV’s role, a detailed guideline which covers various sectors of pharmacovigilance activities should be developed and continuously revised. In addition, agreed core competencies should be reflected into systematic curriculum for the pharmacovigilance personnel and an operating organization should be established.
|
|
|
KEYWORD
|
|
|
Responsible person for pharmacovigilance, Pharmaceutical company, Postmarketing surveillance, Pharmacovigilance
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|