Regulatory affairs là gì

     
01:44 Aug 11, 2015
English to Vietnamese translationsLaw/Patents - Other
English term or phrase: Director of Medical Device Regulatory Affairs & Quality Management
Các bác cho em thuật ngữ trên là Giám đốc gì ạ?
vyhieu12


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Local time: 15:06
Vietnamese translation:giám đốc pháp chế về thiết bị y tế & quản lý chất lượng
Explanation:My suggestion

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This person is a bacninhtrade.com.vn Certified PRO in English to VietnameseClick the red seal for more information on what it means to be a bacninhtrade.com.vn Certified PRO. ", this, event, "300px")" onMouseout="delayhidetip()"> Hoang DanVietnamLocal time: 15:06
Summary of answers provided
5 +1giám đốc pháp chế về thiết bị y tế & quản lý chất lượngThis person is a bacninhtrade.com.vn Certified PRO in English to VietnameseClick the red seal for more information on what it means to be a bacninhtrade.com.vn Certified PRO. ", this, event, "300px")" onMouseout="delayhidetip()">Hoang Dan
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25 mins confidence:
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peer agreement (net): +1
Explanation:My suggestionhttps://en.wikipedia.org/wiki/Regulatory_affairsThis person is a bacninhtrade.com.vn Certified PRO in English to VietnameseClick the red seal for more information on what it means to be a bacninhtrade.com.vn Certified PRO. ", this, event, "300px")" onMouseout="delayhidetip()"> Hoang DanVietnamLocal time: 15:06Native speaker of: English, VietnamesePRO pts in category: 32
Explanation:nếu nói chung thì regulatory affairs chính là quan hệ với chính phủ (government affairs), quan hệ với cơ quan quản lý/hữu quan. Nhưng trong ngành y tế/chăm sóc sức khỏe thì regulatory affairs lại mang ý nghĩa về pháp chế và đảm bảo tuân thủ. ------------- Regulatory affairs (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas: Ensuring that their companies comply with all of the regulations and laws pertaining to their business. Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business. i.e. working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking). Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. ----- The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals. Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including: pharmaceuticals medical devices in vitro diagnostics biologics and biotechnology nutritional products cosmetics veterinary products The regulatory professional"s roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and post market surveillance.Chien NguyenVietnamLocal time: 15:06Native speaker of: Vietnamese, EnglishPRO pts in category: 16

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