食品和药品安全外文文献翻译2018-2019文档格式.docx
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食品和药品安全外文文献翻译2018-2019文档格式.docx
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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(CETER),theDrugRegistrationEvaluationOffice(GRMED),theOfficeofSpecificandHerbalDrugsRegistrationEvaluation (GMESP), and the Office of Post-Approval ChangesEvaluation(GEPRE).Thestaffconsistsofhealthregulationexperts,regulationtechniciansandadministrativepersonnelincludingawiderangeofprofessionals,namely,biologists,bio-medics,chemists,doctors,engineers,lawyers,pharmacists,physiciansandstatisticians.GGMEDperformsdrugregistrationthroughevaluationofdrugsapplications,post-approvalchangeapplicationsanddrugregistrationrenewal.Other
actionsconnectedare“insitu”inspectionsoftheapplicationsmentioned,implementationofauditsontheapplicationreviewprocess,inspectionsonpharmaceuticalequivalenceandbioequivalence/bioavailabilitycenters,evaluationofsafetyandefficacy(clinicaltrials),anddrafting/reviewinglegislation.RecentimprovementstoANVISA'
sreviewprocessincludesystematicstandardizedapproachestothebenefit/riskassessmentofmedicinesandmovingtowardsstepwiseimplementationofGoodReviewPractices(GRevP).
ANVISA'
sothermajorcomponentistheFoodGeneralManagement
Office(GGALI).ItencompassestheRiskAssessmentandEffectivenessOffice(GEARE),theFoodRegistrationOffice(GEREG) andthePost-Registration Food Office (GEPRA). The professional teamreviewing at GGALI consists of health regulation experts andadministrativepersonnel,includingseveralprofessionals,suchasfoodengineers,biologists,pharmacists,nutritionistsandveterinarians.Asanoverviewofthenationalfoodsafetycontrolsystem,the primaryproduction istheresponsibilityoftheagriculturalagencies,whileresponsibilityforthesubsequentstagesofproductionissharedbetweenthehealthandagricultureagencies.Actionsoftheseagenciesarelargelyco-dependent.InBrazil,foodhealthcontrolisamixedmodel.Inpre-marketing,assessmentinvolveshealthpromotion,registerandsafetyassessment,andfoodstandards.
In summary, ANVISA uses best practices and internationalguidelinestocreateBrazil'
sstandards.Informationisfrequentlyobtainedby contact with other regulatory and international agencies andcommunicationusingexistingtechnicalknowledgebasesavailableonvariouswebsitesandconfidentialinformationexchangewithotherregulatoryauthorities.
Hans-GeorgEichler,MD,MSc,SeniorMedicalOfficer,EuropeanMedicinesAgency(EMA),UnitedKingdom(UK),EU,focusedonregulatory science and the evolving role ofpharmacovigilance.Pharmacovigilancestemsfromthe1970sandmeans“closewatch”.Itisthepracticeofmonitoringtheeffectsofmedicaldrugsfollowinglicensureandmarketentry,especiallytoidentifyandevaluatepreviouslyunreportedadversereactions.Itisthescienceandactivitiesrelatedtodetection,assessment,understandingandpreventionofadverseeffectsoranyotherdrug-relatedproblem.
Dr.Eichlerdescribedsomeofthedifficultiesencounteredwhenpracticingprecisionmedicine.Oftenthestratificationcriterionisnotcompletelyunderstood,thenumbersofpatientsaresmallerbutthereareadvancedtherapies(gene,cell,tissue-based),andsomeofthemaretrulypersonalized. Personalized treatment combinations are even morecomplexinthatthescientistsmustdealwithsmallpatientnumbersanditissometimesdifficulttodefineclinicalindications.Dr.Eichleralso
highlighted thedifference(s)betweenefficacyandeffectivenessinclinicalpractice.Efficacyistheextenttowhichaninterventiondoesmoregoodthanharmunderidealcircumstances(monitoringthepatienttakingthedrug).Effectivenessistheextenttowhichaninterventiondoesmoregoodthanharmwhenprovidedundertheusualcircumstancesofhealthcarepractice.Accountingforheterogeneitywillleadtomorepreciseprecisionmedicineandadifferentapproachtodrugdevelopment.Dr.Eichleralsomentionedthatitisverylikelythatregulatorsandthehealthdeliverysystemwillneedtoshiftsomehealthcarepracticesinthefutureincaseweaccountforheterogeneity.
Dr.Eichlerbelievesthatthefutureevolutionofpharmacovigilancewillbefacilitatedbypay-for-performanceandpre-licensingofrealworlddata.Thiswillbethepinnacleofindividualizedpharmacovigilance.Therewillbeashiftfrompopulationtopatientlevel,frompredictiontoobservation-based decision-making. Treatment responsive andnon-responsivewillbeidentified,andtheuseofpatient-leveloutcomeswouldenableoutcome-basedcontractingand,perhapsfurtherimprovepatientsafetyandpublichealthbyfocusingonpatientexperiences.Dr.Eichler concluded by emphasizing that the development ofpharmacovigilancewilllikelybringshiftsoffocusfromsafety-onlytobenefitsandharms,frompharmacovigilancetoknowledgegeneration,andfrompopulationfocustopatient-levelfoc
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