艾昆纬2024年制药和生物技术的安全和监管合规趋势与预测报告英文版12页.pdf

WhitePaper

2024SafetyandRegulatory

ComplianceTrendsand

PredictionsforPharma

andBiotech

MICHELDENARIÉ,PrincipalofRegulatoryAffairsandDrugDevelopmentSolutions

MICHELLEGYZEN,SeniorDirectorofRegulatoryAffairsandDrugDevelopmentSolutions

ARCHANAHEGDE,SeniorDirectorofIntegratedPVSolutions

ALISAHUMMINGS,SeniorDirectorandHeadofMedicalInformationandLocalAEIntakeServices

SIMONJOHNS,DirectorofMedicalInformationandMarketedProductSafety

Tableofcontents

Executivesummary2

Lookingbackat2023,whatsafetyandcompliancetrendssurprisedyou?3

GenerativeAI(GenAI)hascreatedquiteastirthispastyear.Wheredoyousee4

thistechnologyadvancinginthenextyearandwhatwillbethemajorimpact

foryourareasoffocus?

What2024trendsdoyouseeforintaketoolsthathandlestructured,5

semi-structured,andunstructuredadverseevent(AE)dataaswellasbuilttools

forfollow-upautomationandreconciliation?

Fromaregulatoryperspective,whatdoyouforeseeemerginginthenextthreeyears?5

Howshouldpharmacompaniesbeginpreparingtoeffectivelyaddressthesechallenges?

Earlierthisyear,theFDArolledoutdiversityplans.Canyoudescribetheseplans6

andhowyouseethemaffectingtrialdesignin2024?

Ascompaniesdeterminehowtocomplywithdifferentcountries’regulatorylandscapes,6

whatdoyoupredictwillbethebiggestchallengesandwhatstepsshouldcompanies

starttakingtoaddressthem?

Arethereanynewcountryregulationsyou’rewatchingforin2024?7

Itseemsliketheindustryisshiftingtowardssafetyservicesandtechnologyintegration7

tostaycompliant.Whereshouldcompaniesstartwhenitcomestoimplementing

combinedservices?

Manyarewonderingw