食品和药品安全外文文献翻译.docx
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食品和药品安全外文文献翻译.docx
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食品和药品安全外文文献翻译
食品和药品安全的新兴技术外文翻译2018-2019
英文
Emergingtechnologiesforfoodanddrugsafety
WilliamSlikker
Abstract
Emergingtechnologiesareplayingamajorroleinthegenerationofnewapproachestoassessthesafetyofbothfoodsanddrugs.However,theintegrationofemergingtechnologiesintheregulatorydecision-makingprocessrequiresrigorousassessmentandconsensusamongstinternationalpartnersandresearchcommunities.Tothatend,theGlobalCoalitionforRegulatoryScienceResearch(GCRSR)inpartnershipwiththeBrazilianHealthSurveillanceAgency(ANVISA)hostedtheseventhGlobalSummitonRegulatoryScience(GSRS17)inBrasilia,BrazilonSeptember18–20,2017todiscusstheroleofnewapproachesinregulatorysciencewithaspecificemphasisonapplicationsinfoodandmedicalproductsafety.Theglobalregulatorylandscapeconcerningtheapplicationofnewtechnologieswasassessedinseveralcountriesworldwide.Challengesandissueswerediscussedinthecontextofdevelopinganinternationalconsensusforobjectivecriteriainthedevelopment,applicationandreviewofemergingtechnologies.Theneedforadvancedapproachestoallowforfaster,lessexpensiveandmorepredictivemethodologieswaselaborated.Inaddition,thestrengthsandweaknessesofeachnewapproachwasdiscussed.Andfinally,theneedforstandardsandreproducibleapproacheswasreviewedtoenhancetheapplicationoftheemergingtechnologiestoimprovefoodanddrugsafety.TheoverarchinggoalofGSRS17wastoprovideavenuewhereregulatorsandresearchersmeettodevelopcollaborationsaddressingthemostpressingscientificchallengesandfacilitatetheadoptionofnoveltechnicalinnovationstoadvancethefieldofregulatoryscience.
Keywords:
Globalcoalition,Emergingtechnologies,Foodsafety,Drugsafety,Regulatoryagencies,Alternativemethods,Bestpractices,Cross-training
Introduction
Emergingtechnologiesforfoodand drugsafetyassessment representagrowthareaforregulatorysciences.Withthegoaloffaster,lessexpensiveandmorepredictiveassessmentapproaches,manynewtechnologieshavebeenproposed.Althoughsomeofthesenewassessmentapproacheshavegainedconsiderableattention,fewifanyhavebeenuniversallyacceptedasavailabletoreplaceexistingtestingparadigms.Withthisinmindthefocusofthe7thannualGlobalSummitonRegulatoryScience(GSRS17)wasEmergingTechnologiesforFoodandDrugSafety.GSRS17isaninternationalconferenceheldundertheauspicesoftheGlobalCoalitionforRegulatoryScienceResearch(GCRSR),withthegoalofdiscussinginnovativetechnologiesanddevelopingpartnershipstoenhancetranslationofbasicscienceintoregulatoryapplicationswithintheglobalcontext.Theconferenceprovidesaninteractiveplatformforscientistsfromgovernment,industry,andacademic-researchcommunitiestoobjectivelyassesstheutilityofemergingtechnologies(suchas nanotechnology,imaging, omics fortranslationalscience,precisionmedicine, bioinformatic approaches,medicalproductsafety,andfoodsafety)foraddressingregulatoryresearchquestionsandtodiscussthebestwaytotranslatethesetechnologiesintoreal-worldapplications.GSRS17alsoallowedtheopportunitytoexchangeviewsandpracticesthatcanassisttheregulatoryresearchcommunityinharmonizingeducationalandtrainingopportunitiesworld-wide.
Globalregulatorylandscape
Tocomparethestatusofregulatoryscienceasappliedtofoodanddrugsafetyaroundtheworld,theGlobalRegulatoryLandscapewasassessed.TofocusthepresentationsfromBrazil,theEuropeanUnion,NigeriaandJapan,severalcommonquestionswereaddressedbythepresenters.Theseincluded:
1)Whatarethecommonregulatoryscienceissuesandpracticesacrossgovernmentalagencies?
2)Whichinfrastructure/mechanismshouldbedevelopedtoaddressthesecommonissuesandpractices?
3)Howdoyouenvisionthecross-trainingopportunitiestofacilitateknowledgetobeexchangedacrossagencies?
Dr.MeiruzeSousaFreitas,DeputyDirector, Authorization andHealthRegistry,BrazilianHealthSurveillanceAgency(ANVISA),describedthatANVISAhasahierarchybasedonlegislationandacompetencytoeditlegislationonhealthsurveillance-relatedsubjects.ANVISAisveryconnectedtotheglobalcommunityandtheGoodRegulatoryPracticesProcess.Internationalapproachesandinformationarecollectedthroughcontactwithauthoritiesanddiscussionsbasedonthetechnicalprocedureswithinternationalcooperationgroups.
InANVISA,regulationiscoordinatedbytwooffices:
DrugGeneralManagementOffice(GGMED)andFoodGeneralManagementOffice(GGALI),whicharesubordinatetotheAuthorizationandHealthRegistrationDirectory(DIARE).TheGGMEDiscomposedoftheOfficeofSafetyandEfficacyEvaluation(GESEF),theDepartmentof TherapeuticEquivalence (CETER),theDrugRegistrationEvaluationOffice(GRMED),theOfficeofSpecificand HerbalDrugs RegistrationEvaluation(GMESP),andtheOfficeofPost-ApprovalChangesEvaluation(GEPRE).Thestaffconsistsofhealthregulationexperts,regulationtechniciansandadministrativepersonnelincludingawiderangeofprofessionals,namely,biologists,bio-medics,chemists,doctors,engineers,lawyers,pharmacists,physiciansandstatisticians.GGMEDperformsdrugregistrationthroughevaluationofdrugsapplications,post-approvalchangeapplicationsanddrugregistrationrenewal.Otheractionsconnectedare“insitu”inspectionsoftheapplicationsmentioned,implementationofauditsontheapplicationreviewprocess,inspectionsonpharmaceuticalequivalenceandbioequivalence/bioavailabilitycenters,evaluationofsafetyandefficacy(clinicaltrials),anddrafting/reviewinglegislation.RecentimprovementstoANVISA'sreviewprocessincludesystematicstandardizedapproachestothebenefit/riskassessmentofmedicinesandmovingtowardsstepwiseimplementationofGoodReviewPractices(GRevP).
ANVISA'sothermajorcomponentistheFoodGeneralManagementOffice(GGALI).ItencompassestheRiskAssessmentandEffectivenessOffice(GEARE),theFoodRegistrationOffice(GEREG)andthePost-RegistrationFoodOffice(GEPRA).TheprofessionalteamreviewingatGGALIconsistsofhealthregulationexpertsandadministrativepersonnel,includingseveralprofessionals,suchasfoodengineers,biologists,pharmacists,nutritionistsandveterinarians.Asanoverviewofthenationalfoodsafetycontrolsystem,theprimaryproductionistheresponsibilityoftheagriculturalagencies,whileresponsibilityforthesubsequentstagesofproductionissharedbetweenthehealthandagricultureagencies.Actionsoftheseagenciesarelargelyco-dependent.InBrazil,foodhealthcontrolisamixedmodel.Inpre-marketing,assessmentinvolveshealthpromotion,registerandsafetyassessment,andfoodstandards.
Insummary,ANVISAusesbestpracticesandinternationalguidelinestocreateBrazil'sstandards.Informationisfrequentlyobtainedbycontactwithotherregulatoryandinternationalagenciesandcommunicationusingexistingtechnicalknowledgebasesavailableonvariouswebsitesandconfidentialinformationexchangewithotherregulatoryauthorities.
Hans-GeorgEichler,MD,MSc,SeniorMedicalOfficer,EuropeanMedicinesAgency(EMA),UnitedKingdom(UK),EU,focusedonregulatoryscienceandtheevolvingroleof pharmacovigilance.Pharmacovigilancestemsfromthe1970sandmeans“closewatch”.Itisthepracticeofmonitoringtheeffectsofmedicaldrugsfollowinglicensureandmarketentry,especiallytoidentifyandevaluatepreviouslyunreportedadversereactions.Itisthescienceandactivitiesrelatedtodetection,assessment,understandingandpreventionofadverseeffectsoranyotherdrug-relatedproblem.
Dr.Eichlerdescribedsomeofthedifficultiesencounteredwhenpracticingprecisionmedicine.Oftenthe stratification criterionisnotcompletelyunderstood,thenumbersofpatientsaresmallerbutthereareadvancedtherapies(gene,cell,tissue-based),andsomeofthemaretrulypersonalized.Personalizedtreatmentcombinationsareevenmorecomplexinthatthescientistsmustdealwithsmallpatientnumbersanditissometimesdifficulttodefineclinicalindications.Dr.Eichleralsohighlightedthedifference(s)betweenefficacyandeffectivenessinclinicalpractice.Efficacyistheextenttowhichaninterventiondoesmoregoodthanharmunderidealcircumstances(monitoringthepatienttakingthedrug).Effectivenessistheextenttowhichaninterventiondoesmoregoodthanharmwhenprovidedundertheusualcircumstancesofhealthcarepractice.Accountingfor heterogeneity willleadtomorepreciseprecisionmedicineandadifferentapproachtodrugdevelopment.Dr.Eichleralsomentionedthatitisverylikelythatregulatorsandthehealthdeliverysystemwillneedtoshiftsomehealthcarepracticesinthefutureincaseweaccountforheterogeneity.
Dr.Eichlerbelievesthatthefutureevolutionofpharmacovigilancewillbefacilitatedbypay-for-performanceandpre-licensingofrealworlddata.Thiswillbethe pinnacle ofindividualizedpharmacovigilance.Therewillbeashiftfrompopulationtopatientlevel,frompredictiontoobservation-baseddecision-making.Treatmentresponsiveandnon-responsivewillbeidentified,andtheuseofpatient-leveloutcomeswouldenableoutcome-basedcontractingand,perhapsfurtherimprovepatientsafetyandpublichealthbyfocusingonpatientexperiences.Dr.Eichlerconcludedbyemphasizingthatthedevelopmentofpharmacovigilancewilllikelybringshiftsoffocusfromsafety-onlytobenefitsandharms,frompharmacovigilancetoknowledgegeneration,andfrompopulationfocustopatient-levelfocus.Healsoindicateda continuum knowledgegenerationspanningthepre-andpost-licensi
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