艾昆纬-采用技术解决方案来创新和简化您的监管服务（英）-2023

WhitePaperAdopt

Technology

Solutionsto

Innovate

and

StreamlineYour

Regulator

ySer

vicesMICHELLE

GYZEN,SeniorDirector,Regulatory

Affairs

andDrug

DevelopmentSolutions

(RADDS)JENS-OLAF

VANGGAARD,SeniorDirector,GlobalSafety,

Regulatory

andQuality

(SRQ)SolutionsTable

of

contentsIntroduction22TheevolutionofregulatorytechnologyandmanagementEmergingtrendsacrossthe

spaceBuildanew

modelaroundtheaugmentedregulatory

workerI.

Data

governance345II.

Integrated,end-to-end

RIMIII.

Basicaugmentation56IV.

Regulatory

intelligenceV.

Advanced

augmentationThe

impact

onregulatory

professionalsThe

roleofAI6667Howtoprepareefficiently8Abouttheauthors9About

IQVIA10IntroductionPharmaceutical

regulation

is

rapidly

expanding

to

meet

global

demand

forinnovative

drug

products.

As

a

result,

sponsors

must

strive

to

walk

the

fine

linebetween

maintaining

compliance

and

minimizing

the

burden

for

their

staff.

Toadapt

to

the

regulatorycomplexity

inherent

to

global

drug

campaigns,

bothvendors

and

sponsors

are

implementing

new

technology

to

augment

theregulatoryworkflow,

including

automation

and

artificial

intelligence(AI).

No

matterwhere

you

are

in

your

drug

development

journey

and

how

you

plan

to

approachthe

process,

familiarize

yourselfwiththe

regulatorylandscape

and

tech

solutionsavailable

to

augment

yourstaff’s

workload

and

ensure

highly

efficient

processes.Theevolutionof

regulatorytechnologyand

managementRegulatory

managementservices

revolve

aroundthreemaingoals(Figure1).

The

first

isensuringoptimalandtimely

compliancewith

regulationsacrossthe

fullproduct

lifecycle

andglobe.The

secondisexpandingandacceleratingpatientaccesstomedicinesbyoptimizingregulatory

pathways

andoperations.The

thirdisshortening

the

timelinetoapprovalvia

said

optimizedpathways

andoperations.Figure1:

TheCriticalComponentsofRegulatoryManagementCompliance•

Ensureoptimal

and

timely

compliance

with

applicableregulations

globally

across

the

full

product

lifecycleCompliancePatient

access•

Expand

and

accelerate

patient

access

to

medicinesby

optimizing

regulatory

strategy,

pathways

andregulatory

operationsSuccessTimetoapprovalTimeto

approval•

Accelerate

approvals

by

optimizing

regulatory

strategy,pathways

and

regulatory

operationsPatientaccess

|

2Though

transformative

technology

hasrapidlybecomeacorecomponentofregulatory

services,

when

thesesystems

first

began

totake

shape

in

the

1980s,

processeswere

conducted

on

paper

and

in

Excel

(Figure

2).There

wasminimal

technology

available

to

aid

the

effort.

In

the

1990s,the

first

basic

regulatory

information

management

(RIM)systems

emerged

with

a

focus

on

advanced

registrationtracking.

The

2000s

marked

a

shift

to

electronic

papersubmissions,

and

electronic

common

technical

documents(eCTD)andstructured

product

labeling(SPL)becamemandatory.Regulatory

organizationsstarted

toleveragetechnology

toapproachthese

changes.Publishingandviewing

solutionsbecame

anindustry

standard,

andcompaniesbegantodiscusshealthauthority

interactionandsoft

intelligence.However,bytoday’s

standard,

thesetup

wasstill

relatively

old-fashioned.medicinalproducts

(IDMP)

asanextended

product

datastandard,

whichcontinuestoday.New

standards

wereintroduced,includingperformance

qualification(PQ);chemistry,

manufacturing,

andcontrols(CMC);andeCTD

4.0,whichbegantotakeshapewith

theadditionofmoremetadata

anddata-centric

utilizationofelectronic

papersubmissions.There

wasanincreasedemphasisoncloud-based

technology,andthe

initialexploration

ofmoreintelligenttools,

includingroboticprocessautomation(RPA),naturallanguageprocessing(NLP),andAI.By

the

2020s,the

industry

pivoted

toacceleratingintelligenceanddesigningthe

augmentedregulatoryworker.This

entails

upstream

expansionoftheRIM

domainintoregulatory

affairs,

morefocusonregulatory

intelligenceandstrategy,decisionsupport,andincreasedautomationvia

intelligenttechnologies,includingformsofAI,

NLP,

andlargelanguagemodeling(LLM).Inthe

2010s,structured

data

submissionsbecamemoremainstreamwith

theintroduction

oftheeXtendedEudraVigilanceMedicinalProduct

Dictionary(XEVMPD).

Workbeganaroundtheidentification

ofFigure2:

TheEvolutionofRegulatoryTech

andManagement2000s1990s2000s2010s2020s“Electronic

paper”submissions

drivesRIM

system

adoptionStructured

datasubmissions

andcloud

RIM

platformsFirst

basicRIM

systemsAugmentedregulatory

workerPaper

and

ExcelEmerging

trends

across

the

spaceRegulationsandstandards

areincreasinginquantityandcomplexity

aroundtheworld.As

aresult,The

operatingmodelisalsobecomingmorecomplex.Inthe

informationanddata

domain,moreinformationisnowrequiredforsubmissiontohealthauthorities.There

isalsoacontinuedshift

from

submittingworkloads

aremounting.Despitesignificantworktostandardize

regulations

across

markets,

there

continuestobe

variationsinimplementation.For

example,with

IDMP,

differentoperatingapproachesarebeingimplementedacrossdifferentmarkets.Inthisclimate,avirtually

enabledmodelisincreasinglythestandard.To

better

support

this,morecompaniesareturningtodevelopmentandoutsourcing

partners

forassistance.documentation

tosubmitting

data,

andthe

data

andtechnologystandards

forsaid

submissionsvary

acrossmarkets.Hence,data

harmonizationcontinuestobechallenging.As

thetechnologylandscapegrowsmorediverse

via

rapidtechprogress,platforms

must

beabletointegratesolutionstouse

themcollaboratively.There

isanaddedemphasisonaugmentingintegratedplatforms

with

intelligent,

focused

applications

to3

|

Adopt

TechnologySolutions

to

Innovate

and

Streamline

YourRegulatory

Servicesprovide

broader

automation.

This

might

include

the

auto-classification

of

documentation

or

the

identification

ofpatterns

in

health

authority

interactions.Build

a

new

model

around

theaugmented

regulatory

workerSystemic

regulatory

augmentation

enablesprofessionalstofocustheirattention

onthe

vital

activities

needed

toimproveoutcomes.The

goalisnottoreplaceregulatoryprofessionals,but

tolightentheirburdenwith

innovativetechnology

andhigh-quality

data.

Augmentation

helpsmakeinformationreadilyavailableforregulatoryworkers,allowingthemtoperform

with

higherefficiency.Overall,

technology

is

helping

to

build

more

agile

modelsand

businesses

are

leveraging

long-term

implementationand

scale-up

as

opposed

to

the

“big

bang”

implementationused

previously

with

larger

applications.

Due

to

thesefactors,

there

is

an

increased

reliance

on

businessengagement

and

the

availability

of

high-quality

data

todrive

intelligent

applications

and

solutions.Considerthe

threedegreesofaugmentation:fullFromaservices

andresourcingperspective,

currenteconomicdynamics

havealsoled

toincreasedoutsourcing

tomitigatecost

increases.As

marketexpansiongrows,

companiesneed

enhancedlocalexpertise,

andthey

turn

toservice

providers

tosecurethat.

Mergers

andacquisitionsandunplannedregulatoryevents

continuetodrive

demandfortemporary

supportfrom

anoutsourcing

partner.Sponsors

arelookingforstrategic

partners

thatfuse

innovative

technology

andworld-class

services

togethertoprovidemoreefficientsolutions,

ratherthansimplyprovidingmanpowertoexecuteoperations.automation,

semi-automation,

and

exploration

(Figure

3).Fullautomationfocuses

onlowercomplexity

activities,includingbots

orrule-based

automationslikeRPA,

AI,or

those

built

into

operational

applications.

The

middlerange

of

complexity

calls

for

semi-automation

and

moreinnovative

technologies,

including

AI,

machine

learning(ML),

NLP,

LLM,

or

ChatGPT.

These

technologies

help

withdata

extraction,

data

transformation

from

one

format

toanother,suggestions

based

on

previous

experience,

andcontent

generation.

Semi-automation

uses

technology

todo

the

heavy

lifting,

and

then

provides

information

to

aregulatory

professional

to

evaluate,

expand

on,

and

finalize.Figure3:

Multi-faceted

RegulatoryAugmentationRegulatoryprofessionalsMulti-faceted

augmentationFull

automationSemi-automationExplorationComplexityComplexityComplexityAugmentedregulatoryworker••BotsRules-basedautomation••••Data

extractionData

transformationSuggestions••••Smart

searchSummariesData

analysisChatbotContent

generationRPA/ApplicationsAl

/ML

/NLP/LLMAl

/ML

/NLP/LLMOperational

systems,

regulatory

intelligence,

external

data

sourcesInnovativetechnologyHigh-qualitydata

|

4With

high-complexxity

activities,

thereisapivot

from

operationstowardsstrategy

andplanning,andthe

sametechnologiesareused

inamoreexploratory

fashion.This

explorationcentersonhowtomakeinformationeasilyavailableandconsumableforhumans,so

thattheycan

makedecisionsefficiently.Itmightincludesmart

searches,summarizationofinformationordocuments,

lightdata

analysis,

orinformationprovided

throughintelligentchatbots.These

differenttypes

ofaugmentationrun

oneither

operationalsystems,

regulatory

intelligence,orexternal

datasources.To

maketheaugmentedregulatory

workersystem

areality,sponsors

willneed

toconsiderfive

keyareas.DATA

GOVERNANCEI.DATA

GOVERNANCEyouroperationalsystems,

predominantlywithin

the

RIMspace.Strive

tobetter

integrateworkflows

anddata

setsif

theyaren’t

already.Ascenariomightariseinwhichyoudonothaveallthe

data

needed

forthe

augmentationyou’dliketodeliver.Inthissituation,data

coveragemayneed

tobe

expanded

within

the

operationalsystems

orotherdata

sourcescouldbe

added.You

mayalsowanttoincorporatefunctional

systems

outside

ofregulatorytosupport

the

businessprocessforwhichyouaretryingtocreateaugmentation.That

couldmeanputting

anintegrationinplacebetween

yourRIM

solutionandyoursafety

database.Without

good

data,

intelligenttechnologycannotmakeregulatory

workeraugmentation

work.

Dataquality

improveswith

data

governance.Define

whatthatlooks

likeforyourteamandthenassess

andremediateexisting

data

toimprovethefoundationofyourtechnology.II.INTEGRATED,

END-TO-END

RIMYour

RIM

system

doesn’t

need

tobe

asingleplatformfromonevendor,but

thesystems

involvedmustbe

interactive

toprovideastrong

foundationforintelligencetorun

on.The

data

issynonymous

with5

|

Adopt

TechnologySolutions

to

Innovate

and

Streamline

YourRegulatory

ServicesIII.BASIC

AUGMENTATION1.

Identifying

the

rightquestions.2.

Findingthe

rightanswers.OnceaRIM

system

anddata

governanceareinplace,basicaugmentationbegins.This

typically

meansimplementingautomationsinoperationalsystems,includingRPAinpublishing,rule-based

automationswithin

systems,

orsomethatuse

applications,likehyperlinkingandbookmarks.

Fromapublishingstandpoint,

basicaugmentationiswhereyoucanstart

implementingsupport

forinformationanddataexploration.The

goalistolookat

thedata

toapplysmart

searchesandbots

tomakeinformationmorereadilyavailabletotheregulatory

professionals,allowingthemtosave

timeandincreaseefficiency.3.

Enteringthe

relevantdata

inthe

system.This

wouldproduceamoreintelligent,efficientprocessand,thus,

higherquality

data.V.

ADVANCEDAUGMENTATIONThe

last

phaseisadvancedaugmentation,whichincludescontentgeneration.This

mightbe

ChatGPTlookingtogenerateanationallabelbased

onacorelabel,ortotranslatealabelfrom

onelanguagetoanother.Itcouldalsobe

data

extraction

tools.ManycompaniesarelookingtoprepareforIDMPsubmissions,andthereissignificantdata

onhowtoextract

andtransform

informationfrom

labelsandModule3documents

tomakethatprocesslessburdensome.Some

optionsincludedata

miningorembeddingsuggestions

based

onintelligenceandexperience.For

example,when

youmakeachoice,the

system

couldprompt:Are

youawarethatinthepast

percentageofcases

youdidthis?Fromthere,aregulatory

workercouldmakeaneducated

decision.IV.REGULATORYINTELLIGENCETypically,companiesthenshift

theirfocustotheregulatory

intelligence,strategy,andplanningdomains.To

takeamorerisk-balancedapproach,considerwhat

hasbeen

donepreviously

asopposedtowhat

the

healthauthority

expects.

Sponsors

mayuse

monitoringandimpact

assessment

workflowsthatexaminehowbest

toimplementbots

andothertechnologiestodomonitoring,andhowtoputtogetheracoordinatedimpact

assessment

fornew

regulatory

requirementsacrossthe

organization.Other

companieslooktoexternal

providers

inthe

regulatory

intelligencedomaintoprovidethese

capabilities.The

impact

on

regulatory

professionalsAs

regulatory

processesarefurther

augmented,therewillbe

areduction

intask-based

andhigh-volumeregulatory

activity

(Figure4).This

reflects

apivotfrom

theresourceallocationpyramidwesee

today,whichspendsadisproportionateamountonmanualmaintenanceactivities

thatarenotdirectly

relatedtocorecompetenciesanddevelopment.Publishingisanareawherethereisalargecrosssection

ofdataandhigh-volumethroughputtocreatearegulatorysubmission.The

associatedefforts

willbe

reduceddramaticallyvia

automation.As

aresult,

regulatoryprofessionalscan

spendmoretimeonstrategy

andwork

tomaintainoversight.Regulatory

intelligenceislargelyinformationmanagementanddocumentdriven,

utilizingquestionsandanswers.

Areferencedata

modelforkeyregulatoryintelligencecouldenableusers

tolinkintotheirRIMsystem

tostart

anddrive

intelligentworkflows

andautomation.Informationcouldthenbe

pulledintothe

operationalsystem,

e.g.,pathway,timeline,andprerequisitesforinitialmarketingauthorizationapplications(MAAs)

orvariations.Utilizingtheregulatoryintelligenceinthismannerwillaugmenttheregulatoryprofessional,enablingthemtoprovide

targeted

answerstospecific

questions

ratherthan:

|

6Figure4:

HowAutomationReducesWorkloadsStrategicregulatory•

Augmented

workforce

leveragestechnology

andautomation

toaccelerateregulatory

strategySpecialty

expertiseandprogrammanagement•

Specific

Aorregulatory

functionalexpertise

toguidedevelopment•

Local

representation•

Humanoversight

oftechnology-enabledprograms~35%~2

5%~40%Task-basedregulatory

activity•

Augmented

workforce

dramaticallydecreases

timespent

onrepetitive,high-volume,

ormanualtasksAutomationalsoexpedites

the

gatheringandanalyzingofregulatory

intelligenceandguidancetosupport

drugproduct

strategy.As

sponsors

aimtoprioritizeresourcesonspecialty

services

andtechnologyprogramsAI

can

increasespeed

andaccuracy

forregulatory

affairsworkersbyquickly

identifying

regulatory

pathwaysandconducting

riskassessments

thanks

topredictiveanalytics

forregulatory

outcomes.Furthermore,healthauthority

communicationscouldbe

automated,andthe

submissionandpublishingprocesscouldbegreatly

expedited

byminimizingthe

need

formanualprocessing,bookmarking,

andhyperlinking.andproduct

management,theycan

better

supporttechnology-enabled

programs.The

need

forlocalregulatory

expertise

won’t

goawayanytime

soon.As

itevolves,

teamswillneed

tomaintainhumanoversightofthe

automationsandAI

programsdeveloped.This

isamajorshift

inhowregulatory

professionalswork

todayandnecessitates

well-distributed

skillsets

andresources.There

isstill

muchtouncoverabout

ChatGPT

andothergenerative

AI

applications.Developers

andusers

mustdeterminethe

estimated

versus

actual

efficiency

gained,aswellastheinitialandongoingcosts

andhowtomitigatethem.Itisalsoimportant

todeterminehowtosafeguardthe

data

beinginputintothese

systems.

Thisisahugeobstacle,

given

the

proprietary

natureofthedata

supported

inregulatory

affairs,

andsomethingtobe

addressed

soonerratherthanlater.The

role

of

AIAdvancedautomation,likegenerativeAI

(GenAI),

canacceleratefunctionalities

indata

mining,data

analytics,software

operation,andregulatory

contentcreation.Throughdata

mining,regulatory

intelligenceanddocuments

can

be

gatheredfrom

avariety

ofsources.Documents

can

be

parsed

intodata

andmanipulated,whilenew

contentcan

be

generatedinmultipleformsandautomaticallyclassifiedforuse.Fromthere,wecan

interpretregulatory

intelligenceinnew

ways,

getactionable

insightsfrom

ourdata,

automaticallydevelopregulatory

strategy,andgeneratesubmissions.Thesearethe

buildingblocks

forthe

augmentedworker.IfyouconsiderguidanceandmandatesforeCTD4.0,the

industry

issometimesslowtoadoptcertaintechnologies.As

aresult,

the

timelineforimplementingsomeofthese

solutionsandrealizingtheirbenefitsmightbe

unclear.As

it

continuestodevelop,AI

willevolve

at

amuchfaster

pacethanit

hashistorically.Itiscritical

toaccountforhownarrowAI

willdevelopintoAdopt

TechnologySolutions

to

Innovate

and

Streamline

YourRegulatory

Servicesaspirational,empathicAI

andthe

potentialchallenges,both

technicalandethical,

thismaycause.Howdoesthismanifest

inthetechnologysystems

andsolutionsofthefuture

andhowdoteamsprepare?The

next

thingtoconsiderisprocess.As

sponsors

andvendors

developtechnologies,they

must

looknotonlyat

howtechnologydrives

efficiency,but

alsoat

howexisting

processesimpact

said

technology.Determinehowtoredesignyourprocessesandimplementationframeworkif

needed.

Leverageorganizationalchangemanagementmethods

andapply

them

totechnologyadaptation.

Furthermore,

don’t

be

afraidtouse

aphasedimplementation

approach.Infact,

most

organizationspreferthiswhen

leveragingtechnology

thathasnotbeen

previously

utilized.How

to

prepare

efficientlyAs

youbuildout

yourtechsolutionsandwork

toaugmentyourregulatory

workforce,

considerhowyoucan

prepareeffectively.

Beginbyincreasingawarenessandopennesstotechnologyandautomationacrossyourculture.To

instill

enthusiasmfortechnologyacrossyourregulatory

organization,you’ll

need

toembraceimperfection

andlearning.As

yourteamdesignssolutions,

encourageagility

andawarenessthatthe

firstiterationofatechnologysolutionisneverthe

best.

Theprocessisoneofcontinuousimprovement.Set

theseexpectations

with

yourorganizationearly

tohelpensurethe

successofthe

augmentedregulatory

worker.Finally,evaluatehowestablishing

apartnership

withanexperienced

regulatory

resourcesorganizationcanhelpyouleveragethese

new

technologiestoprovidebetter

service

andyield

high-quality

outcomes.Seek

toidentify

partners

thatarewellsuitedtoaccommodatethe

sizeofyourcompany,type

ofdrug

products,

andstages

ofdevelopment.Culturallyalignedproviders

willhelpyourealizeyourgoalsvia

theirtechnology,resourcecapabilities,andregulatory

experience.Whether

youopttobuildyourown

system,

buy

aplatform,

orwork

with

aregulatory

services

partner,start

adoptingaframeworktoaccommodateyourprocessearly

on;thiswillensuremaximumsupport

forpatients

andemployees.Identify

technologychampionswho

understandthe

inherentvalueofnew

technologywithin

theorganization.Fromthere,involvestakeholders

viaregularmeetingsorcommunicationstokeepthemabreast

ofhowchangeswillimpact

themandthecompany.Establish

employeetrainingprogramsforusingnew

technologiestoredirect

knowledge

workersandensurethatyourresourceskillsets

areidentified

andcompletetomeet

the

new

needs

ofyourorganization.