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Related Flashcards
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Cards In This Set
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GCC-DR
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Gulf Central Committee for Drug Registration-1999-Middle East States: Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates
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EMA
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European Medicine Agency (formerly EMEA)-27 countries plus Norway and Iceland-Scientific and quality assessment of Drug safety, efficacy and manufacturing quality
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CA
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Competent authority
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MAH
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Marketing Authority Holder
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QP
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Qualified Person-MAH legal responsibility to have QP for drug batch release (including EU, Canada, Switz, AUS, Jp, New Zealand)-MAH legal responsibility to have QP for Pharmacovigilance
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OECD
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Organization of Economic Cooperation and Development-"Principles of GLP---Outline for GLP
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PLM
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Product Lifecycle Management-management of product life cycle, from conception, through design and manufacturing, to launch, service and disposal.-MAH needs to track changes, archive information, update CA and evaluate and obtain approval if changes have significant impact on product performance
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PVP
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PharmacoVigilance Plan:-Activities related to detection, assessment, understanding and prevention of adverse events, or other drug-related problems-MAH and CA responsibilities
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FMEA
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Failure Mode Effect Analysis
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