食品和药品安全外文文献翻译2018-2019Word文件下载.docx
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食品和药品安全外文文献翻译2018-2019Word文件下载.docx
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EmergingtechnologiesforfoodanddrugsafetyWilliamSlikker
Abstract
Emergingtechnologiesareplayingamajorroleinthegenerationofnewapproachestoassessthesafetyofbothfoodsanddrugs.However,the integration of emerging technologies in the regulatorydecision-makingprocessrequiresrigorousassessmentandconsensusamongstinternationalpartnersandresearchcommunities.Tothatend,theGlobal Coalition for Regulatory Science Research (GCRSR) inpartnershipwiththeBrazilianHealthSurveillanceAgency(ANVISA)hostedtheseventhGlobalSummitonRegulatoryScience(GSRS17)inBrasilia,BrazilonSeptember18–20,2017todiscusstheroleofnewapproachesinregulatorysciencewithaspecificemphasisonapplicationsinfoodandmedicalproductsafety.Theglobalregulatorylandscapeconcerningtheapplicationofnewtechnologieswasassessedinseveralcountriesworldwide.Challengesandissueswerediscussedinthecontextofdevelopinganinternationalconsensusforobjectivecriteriainthedevelopment,applicationandreviewofemergingtechnologies.Theneedforadvancedapproachestoallowforfaster,lessexpensiveandmorepredictivemethodologieswaselaborated.Inaddition,thestrengthsand
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weaknessesofeachnewapproachwasdiscussed.Andfinally,theneedforstandardsandreproducibleapproacheswasreviewedtoenhancetheapplicationoftheemergingtechnologiestoimprovefoodanddrugsafety.TheoverarchinggoalofGSRS17wastoprovideavenuewhereregulatorsandresearchersmeettodevelopcollaborationsaddressingthemostpressingscientificchallengesandfacilitatetheadoptionofnoveltechnicalinnovationstoadvancethefieldofregulatoryscience.
Keywords:
Globalcoalition,Emergingtechnologies,Foodsafety,
Drugsafety,Regulatoryagencies,Alternativemethods,Bestpractices,Cross-training
Introduction
Emerging technologies for food anddrug safetyassessmentrepresentagrowthareaforregulatorysciences.Withthegoaloffaster,lessexpensiveandmorepredictiveassessmentapproaches,manynewtechnologieshavebeenproposed.Althoughsomeofthesenewassessmentapproacheshavegainedconsiderableattention,fewifanyhavebeenuniversallyacceptedasavailabletoreplaceexistingtestingparadigms.Withthisinmindthefocusofthe7thannualGlobalSummitonRegulatoryScience(GSRS17)wasEmergingTechnologiesforFoodandDrugSafety.GSRS17isaninternationalconferenceheldundertheauspicesoftheGlobalCoalitionforRegulatoryScienceResearch(GCRSR),withthegoalofdiscussinginnovativetechnologiesand
developingpartnershipstoenhancetranslationofbasicscienceintoregulatory applications within the global context. The conferenceprovidesaninteractiveplatformforscientistsfromgovernment,industry,andacademic-researchcommunitiestoobjectivelyassesstheutilityofemerging technologies (such asnanotechnology, imaging,omicsfortranslational science, precision medicine,bioinformaticapproaches,medicalproductsafety,andfoodsafety)foraddressingregulatoryresearch questionsandtodiscussthebestwaytotranslatethesetechnologiesintoreal-worldapplications.GSRS17alsoallowedtheopportunitytoexchangeviewsandpracticesthatcanassisttheregulatoryresearch community in harmonizing educational and trainingopportunitiesworld-wide.
Globalregulatorylandscape
Tocomparethestatusofregulatoryscienceasappliedtofoodanddrugsafetyaroundtheworld,theGlobalRegulatoryLandscapewasassessed.TofocusthepresentationsfromBrazil,theEuropeanUnion,NigeriaandJapan,severalcommonquestionswereaddressedbythepresenters.Theseincluded:
1)Whatarethecommonregulatoryscienceissues and practices across governmental agencies?
2) Whichinfrastructure/mechanismshouldbedevelopedtoaddressthesecommonissues andpractices?
3) Howdoyou envisionthe cross-trainingopportunitiestofacilitateknowledgetobeexchangedacrossagencies?
Dr.MeiruzeSousaFreitas,DeputyDirector,AuthorizationandHealthRegistry,BrazilianHealthSurveillanceAgency(ANVISA),describedthatANVISAhasahierarchybasedonlegislationandacompetencytoeditlegislationonhealthsurveillance-relatedsubjects.ANVISAisveryconnectedtotheglobalcommunityandtheGoodRegulatoryPracticesProcess.Internationalapproachesandinformationarecollectedthroughcontactwithauthoritiesanddiscussionsbasedonthetechnicalprocedureswithinternationalcooperationgroups.
InANVISA,regulationiscoordinatedbytwooffices:
DrugGeneralManagementOffice(GGMED)andFoodGeneralManagementOffice(GGALI), whicharesubordinate tothe AuthorizationandHealthRegistrationDirectory(DIARE).TheGGMEDiscomposedoftheOfficeof Safety and Efficacy Evaluation (GESEF), the DepartmentofTherapeuticEquivalence(CET
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- 食品 药品 安全 外文 文献 翻译 2018 2019