Regulatory Science Required for Supervisor-General at Pharmaceutical Company

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  • 製薬企業の総括製造販売責任者に求められるレギュラトリーサイエンス
  • セイヤク キギョウ ノ ソウカツ セイゾウ ハンバイ セキニンシャ ニ モトメラレル レギュラトリーサイエンス

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Abstract

<p>There is a legally responsible person at pharmaceutical company named Supervisor-General which needs to be pharmacist or personnel who has pharmaceutical educational background. It is one of licensing requirements for marketing authorization holder (MAH) of pharmaceutical products to appoint a Supervisor-General based on the Pharmaceutical and Medical Devise Act. Supervisor-General for pharmaceutical products has an overall responsibility of the product which is released to market in Japan on quality management and post-marketing safety management. As eligibility requirements, Supervisor-General needs to have;</p><p>1) work experience on regulatory affairs, development, quality assurance or safety management associated with first-class marketing license of pharmaceuticals for a minimum of three years.</p><p>2) ability to comprehensively understand and make appropriate judgements on pharmaceutical regulations, product characteristics, business processes from raw material procurement to product shipment, manufacturing methods and manufacturing control, quality assurance duties and safety management duties in addition to pharmacist as of this moment.</p><p>As a Supervisor-General working at a pharmaceutical company, there are variety of things to be considered such as impact on product quality/efficacy/safety, regulatory compliance, collaboration/communication, and timely decision/action. In this manuscript, personal opinions on the requirements of Supervisor-General including regulatory science are shared by introducing specific cases.</p>

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