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Regulatory Information Management: New Technologies To
Improve Compliance And Cycle Times While Reducing Costs
By Jenell Skemp
By Dr. Satish Tadikonda
%oda&'s !ife scieces id)str& faces ma& cha!!eges as dr)g deve!opmet costs coti)e to c!imb* pricig press)res mo)t* ad e+ g!oba! markets gai critica!
importace. ,t the same time* the -.,* /0,* ad other reg)!ator& bodies are e1padig ad amedig re2)iremets* c!iica! tria!s are becomig more comp!e1* ad
p)b!ic disc!os)re demads are icreasig. %his icreases the importace* comp!e1it& ad risk re!ated to maagig reg)!ator& iformatio assets.
,ccordig to aa!&st firm 3.4 5ea!th 3d)str& 3sights* a e+ dr)g costs from 6800 mi!!io to 61.2 bi!!io to brig to market* ad a 2)arter of this cost is reg)!ator&
cotet re2)iremets. %he meas that the !ife scieces id)str& speds severa! bi!!io do!!ars a &ear o the maagemet of cotet ad reg)!ator& iformatio.
3 respose to this h&per-competitive g!oba! market* ma& pharmace)tica! compaies have )dergoe radica! trasformatios to become more agi!e i deve!opig e+
dr)gs to address )met medica! eeds. %his has ic!)ded massive restr)ct)rig* reegieerig of ke& 78. processes* e+ mode!s of parterig ad o)tso)rcig ke&
deve!opmet activities to 479s. %hese moves to a more agi!e eterprise m)st ot be hobb!ed b& c)mbersome reg)!ator& iformatio maagemet (730$ paradigms based
o !egac& thikig ad s&stems.
%his artic!e +i!! e1p!ore e+ 730 approaches ad techo!ogies for better maagemet of ad access to reg)!ator& iformatio. 7eg)!ator& data ad the re!ated iformatio
are importat corporate assets* s)pportig ma& cross-f)ctioa! processes s)ch as ma)fact)rig* 78. doc)met a)thorig ad c!iica! tria! s)bmissios. :e+
approaches i cotet maagemet ca improve reg)!ator& a)thorig ad p)b!ishig. %his is defied b& a move from a doc)met-cetric to a cotet-cetric approach to
iformatio.
Regulatory Challenges
7eg)!ator& professioa!s (7;$ face a shiftig !adscape +hi!e str)gg!ig +ith pro!iferatig iformatio so)rces* variab!e data 2)a!it& ad heterogeeo)s data. %oo ofte
iformatio maagemet strategies ad s&stems are ot desiged to cross orgai<atioa! bo)daries. 7eg)!ator& doc)met creatio ad iformatio maagemet i a !ife
scieces compa& caot be see as a discrete activit&. 3deed* s)ch data is )sed b& ma& departmets +ithi the eterprise for s)ch activities as b)siess deve!opmet*
marketig* !abe!ig* s)pp!& re!ease* !oca! affi!iate trackig* ad for third part& iformatio e1chage ad co!!aboratio. =itho)t a ho!istic vie+ of reg)!ator& iformatio
maagemet as a eterprise-+ide process* the compa& is great!& hampered.
9e prob!em is the over+he!mig amo)t of data* doc)mets* ad tasks 7;s dea! +ith* m)ch of it red)dat. , t&pica! reg)!ator& affairs departmet ca dea! +ith 2*000
s)bmissio doc)mets i a give 2)arter* ad ma& more at !arger compaies. 0ior chages i doc)mets* !abe!s* statistica! aa!&ses* etc. are the orm* creatig a ripp!e
effect thro)gh tho)sads of doc)mets over ma& &ears. %he doc)met trackig ad processig is massive. /2)a!!& sigificat is the +ide rage of differet departmets
ad idivid)a!s cotrib)tig to these >reg)!ator&? activities. 7eg)!ator& professioa!s eed visibi!it& ito critica! iformatio +hich is too ofte iso!ated i !oca!*
departmeta! data ad doc)met si!os* egative!& affectig reg)!ator& ad operatioa! comp!iace* strategic p!aig* iovatio* time!ies ad prod)ctivit&.
@ma!!er compaies face simi!ar cha!!eges at a sma!!er sca!e. 0a& fee! the prob!ems ac)te!& at partic)!ar if!ectio poits A a e1padig prod)ct portfo!io* s)bmissio
dead!ies* or geographic e1pasio. %he& the recogi<e that the scope of the reg)!ator& iformatio maagemet cha!!ege has e1paded e1poetia!!& at a time +he
there is o bad+idth b& ke& persoa! to p)t e+ processes ad s&stems i p!ace.
New Approaches to Regulatory Management
7eg)!ator& strategists ad operatios professioa!s a!ike ca beefit from a iformatio maagemet approach that itegrates comprehesive g!oba! reg)!ator&
iformatio ito a sig!e* ro!e-based vie+. Bife sciece compaies that ma1imi<e ad !everage orgai<atioa! iformatio across a!! operatios* ic!)dig 78.*
s)bmissios* !abe!ig ad marketig* gai a strategic advatage. ,chievig this* ho+ever* is a ta!! order.
=hat is eeded is a trasformative* reg)!ator& iformatio maagemet s&stem that he!ps 7;s better track ad maage comp!e1 g!oba! reg)!ator& data ad processes
ic!)dig correspodece* commitmets* approva!s ad maagemet. %his ca he!p the 7; better p!a* coordiate ad e1ec)te their reg)!ator& activities ad achieve
s)perior comp!iace. =hat sho)!d 7;s !ook for i s)ch a s&stemC
D!og E 9ctober F0* 201F
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Ge& reg)!ator& iformatio sho)!d be gathered ad preseted i ro!es-orieted (e.g. /1ec)tive* 7eg)!ator&* 404* etc.$ dashboards thro)gh a it)itive +eb based s&stem.
%he s&stem brigs together data )sed to p!a reg)!ator& activities* ic!)dig commitmets* fi!ig p!as ad mi!estoes* to operatioa! iformatio* ic!)dig*
correspodece* reg)!ator& time!ies* cotacts* !iceses* reportig* prod)ct parters* maiteace ad 404 chages.
/ach activit& is tracked ad maaged. =ith commitmets* for e1amp!e* the 7; ca moitor a!! ob!igatios to hea!th a)thorities ad be otified of )pcomig re2)iremets.
7;s sho)!d e1pect a fi!ig p!a maagemet abi!it& for s)bmissios from iceptio to ed. %his ic!)des creatig the iitia! p!a* gatherig re2)ired s)bmissio data from
m)!tip!e so)rces* ad trackig o)tp)t ad registratio. D& coordiatig m)!tip!e cotrib)tors i a time!& +a& i the +orkf!o+* fi!ig p!a f)ctioa!it& ca e!imiate the
eed to costat!& moitor s)bmissios. 7;s reso)rces ca be dep!o&ed to more va!)e added activities +ith s)ch efficiec& gais.
Benefits of olistic Approach
, actioab!e dashboard ca provide trasparec& o the stat)s of reg)!ator& activities ad it)itive iformatio access for the etire dr)g portfo!io. %his is )sef)!
cosiderig that 7;s so)rce data ad coordiate activities across m)!tip!e departmets ic!)dig 7eg)!ator& ,ffairs* 78.* @)pp!&* 4ommercia!* ad others. 3t is a!so
he!pf)! for preparig for ispectios ad a)dits or faci!itatig parterships. %he >oe so)rce of tr)th? p!atform provides the reg)!ator& professioa! +ith oe c!ick
ite!!igece from a& !ocatio for a)dits ad ispectios from reg)!ators. 4,;,s* fo!!o+-)ps* fies* ad +astig moe& o redoig +ork is great!& red)ced.
Hser-specific dashboards sho)!d* at a miim)m* track the re!atioships bet+ee re!evat correspodeces* commitmets* ad s)bmissios a!! i oe s&stem ad vie+. %his
+i!! es)re )sers at differet !eve!s ad +ith differig resposibi!ities ca be empo+ered +ith the iformatio eeded to sta& o co)rse dai!& +hi!e p)shig for+ard +ith
improvemets to ehace comp!iace* prod)ctivit& ad competitiveess.
3 a e1amp!e of improvig g!oba! reg)!ator& practices* oe top g!oba! !ife sciece compa& istit)ted a iteratioa! reg)!ator& iformatio maagemet s&stem to
s)pport more tha 1*000 )sers i 80 co)tries. %he s&stem tracks g!oba! prod)ct s)bmissios* cotacts* commitmets* mi!estoes* registratios ad o-goig maiteace
s)bmissios. %his stadardi<es g!oba! reg)!ator& processes ad provides e1ec)tives +ith time!& reportig. %he s&stem a!!o+s m)!tip!e cotrib)tors to +ork i para!!e! o
cotet creatio ad revie+* providig more rea!-time co!!aboratio. ,mog the beefits gaied +ere red)ctio i red)dat data etr&* ic!)dig time spet d)p!icatig
iformatio i !oca! trackers* ad red)ctio (or e!imiatio$ of time re2)ired to respod to red)dat 2)eries from regioa! h)bs.
%he prod)ctivit& gais from this techo!og& ofte s)pport icreased )mbers of s)bmissios +ith the c)rret reg)!ator& affairs departmet headco)t. %he reg)!ator&
iformatio maagemet s&stem ca a!so s)pport other divisios' comp!iace (e.g. commercia! prod)ct re!ease$I provide g!oba! shared trasparec& o )pcomig
reg)!ator& activities +itho)t cotactig a!! ivo!ved parties )p frotI ad red)ce the )mber ad comp!e1it& of @9;s to maage comp!iace.
;ortfo!io p!aig a!so becomes m)ch easier to do. 7;s are bombarded +ith 2)estios ad research re2)ests from the commercia! ad ma)fact)rig sides of the
compa&: =hat has bee approved +here* idicatios* commitmets* etc. =hether &o) have 50 markets +ith h)dreds of prod)cts* or t+o prod)cts i oe co)tr& b)t a
sma!! 7; staff* these re2)ests sca!e to become h)ge!& comp!e1 +itho)t a 730 s&stem. , itegrated ad sig!e p!atform vie+ ito reg)!ator& ad c!iica! data gives 7;s a
sig!e* g!oba! >so)rce? of the tr)th.
Content Management elps Regulatory Authoring and !u"lishing
7;s rep)rpose* re+rite* track ad maage tho)sads of doc)mets for reg)!ator& p)rposes ever& 2)arter. %hese doc)mets become ke& corporate assets )sed across the
eterprise. 3 !ight of these immese a)thorig* p)b!ishig* trackig ad maagemet eeds* the e1t big advace i improvig comp!iace +hi!e red)cig c&c!e times ad
costs is the itegratio of so)rce cotet for reg)!ator& a)thorig ad p)b!ishig.
%o achieve this* some compaies are e1p!orig techo!og& to decostr)ct doc)mets behid the scees so that the core pieces of iformatio i them ca be tracked ad
re)sed. :e+ doc)mets are the +ritte* ofte i a semi-a)tomated fashio* i !arge part thro)gh the assemb!& of a!read& created ad approved cotet.
@ome !ife sciece compaies have attempted* )s)ccessf)!!&* to do so +ith e!ectroic doc)met maagemet s&stems. %hese are a e!ectroic s)bstit)tio for paper
co)terparts. %he basic prob!em +ith doc)met maagemet techo!og& is that the cotet resides !ocked i the doc)met itse!f* +ith o itercoectig et+ork of core
data or r)!es across the eterprise. %h)s the va!)e of the cotet is !imited ad it becomes easi!& !ost ad diffic)!t to )pdate.
,!terative!&* a str)ct)red cotet maagemet s&stem addresses these !imitatio b& orgai<ig a!! cotet i doc)mets i data compoets* each gra)!ar!& idetified*
cata!og)ed* ad stored i the cotet !ibrar& for re)se* trackig* traceabi!it&* ad reg)!ar )pdates. %his t&pe of s&stem eab!es prod)ctivit& ad 2)a!it& gais thro)gh the
re)se of core data paired +ith the app!icatio of specific reportig temp!ates ad b)siess r)!es.
%he !ife scieces id)str& is partic)!ar!& +e!! s)ited to marr&ig str)ct)red cotet maagemet ad reg)!ator&
iformatio maagemet. %he deve!opmet of #)st oe dr)g t&pica!!& geerates tho)sads of doc)mets
comprisig mi!!ios of pages. @igificat!&* the !eve! of data re)se amog doc)mets is 2)ite high A )p to t+o-
thirds of data is re)sed* accordig to a id)str& st)d& at :ovartis. 3 this st)d&* compoet re)se across pre-
c!iica! ad c!iica! st)d& cotet +as aa!&<ed. @eve doc)mets t&pes +ere e1amied: ;harmacokietic
@t)dies* %o1ico!og& ;rotoco!s (%;$* %o1ico!og& 7eports (%7$* ;rotoco! @&opses (@;$* 3vestigators Droch)res
(3D$* 4!iica! %ria! ;rotoco!s (4%;$* ad 4!iica! @t)d& 7eports (4@7$. %he ed res)!t of this >iformatio
!ifec&c!e? aa!&sis +as that t&pica!!& )p to t+o-thirds of data +as re)sed across doc)mets. (;!ease see the
accompa&ig graph chart.$0a& t&pes of iformatio* s)ch as a @t)d& 9b#ective* have a !ifec&c!e +e!! be&od a
simp!e !ik to oe or t+o doc)mets. 3 fact* some iformatio segmets persist for ma& geeratios of
doc)met c&c!es ad have !ife-spas +hich ca be )p to a decade i !egth. /1amp!es ca be fo)d +here iformatio is created back i the discover& phase ad persists
+e!! ito ;hase 333 ad 3J 4!iica! %ria!s. D& re)sig cotet* compaies ca dramatica!!& red)ce time to market b& compressig doc)met c&c!e times +hi!e improvig
doc)met 2)a!it& ad speedig )p reg)!ator& iteractios.
#alue of $tructured Content Approach
=hi!e ma& gro)ps i the eterprise derive beefit from a str)ct)red cotet approach* 7;s get sigificat va!)e from it. -irst* the& ab!e to easi!& fid ad !everage
compa& cotet* for e1amp!e 2)ick!& b)i!dig a reg)!ator& s)bmissio doc)met o-demad from a searchab!e !ibrar& of core data compoets. ;erhaps eve more
importat!&* the& a!so ko+ the f)!! pedigree of the iformatio* th)s he!pig to es)re that the >correct? iformatio is beig )sed. %he iformatio is f)!!& traceab!e from
fia! form back to its so)rce* +ith a!! s)bse2)et edits* revie+s* commets ad )ses ko+.
, additioa! capabi!it& is the abi!it& to chage ad va!idate a sig!e doc)met temp!ate ad app!& the chages to h)dreds of doc)mets. %hese capabi!ities es)re that
the correct data is icorporated ito the respose* a!! s)bmissio re2)iremets are met* e!ectroic sig-offs are preset* ad the !atest reg)!ator& r)!es are f)!fi!!ed.
.oe correct!&* a !ife sciece compa& ca set a )der!&ig architect)re re2)ired to s)pport +hat +i!! amo)t to mi!!ios of iformatio segmets i h)dreds of
tho)sads of reg)!ator& doc)mets to be created i the comig &ears. 3 a e1amp!e of this* a .irector of 7eg)!ator& ,ffairs at a !ife sciece compa& cited the re-)sab!e
cotet approach for savig his compa& time ad moe&. %he ke& to this strateg& is the fact that a!! stadards are co)p!ed to form a coti))m from cotet creatio to
)se. -or e1amp!e* if the cotet is migrated to the e@tabi!it& stadard* it co)!d potetia!!& be re)sed i the .r)g-Bistig .ata sectio of a @;B !abe! (+hich i t)r ca be
re)sed i both 0od)!e 1 ad F of the 4%.$. @imi!ar!&* for g!oba! !abe!ig cocepts* core data sheet cotet is re)sed i @;B for H.@. !abe!s ad for !abe!s across differet
/)ropea markets. ,& chages i so)rce cotet ca be absorbed b& the do+stream cos)mers* th)s res)!tig i sigificat cost savigs from havig to costat!&
chage m)!tip!e cotet istatiatios idivid)a!!& i !ight of )pstream so)rce chages.
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@tr)ct)red cotet maagemet ca he!p the reg)!ator& professioa! respod to s)dde evets. -or e1amp!e* a !arge H.@. pharmace)tica! compa& faced a emergig @,/
(severe adverse evet$ for a e+ dr)g )der deve!opmet. .ra+ig from the core data compoet !ibrar&* the 7; a)to-geerated the re2)ired commo forms ecessar& to
respod to m)!tip!e reg)!ator& a)thorities sim)!taeo)s!&. %he s&stem ic!)ded o!& those variab!es ad parameters that +ere appropriate to the specific dr)g* ad es)red
that a!! ecessar& data +as preset prior to s)bmissio. 3f c!iica! ad reg)!ator& data is maaged i a str)ct)red cotet maagemet s&stem* the a 7; ca !everage
these data compoets to a)tomate creatio of a& p!as for differet phases of st)d& i differet co)tries.
3 coc!)sio* a !ife sciece compa& takig a more sophisticated reg)!ator& iformatio maagemet approach ca better maage ad a)tomate the comp!e1 reg)!ator&
ad cotet re2)iremets of the dr)g prod)ct !ife c&c!e* !eadig to faster market peetratio at !o+er cost.
A"out the Author
.r. @atish %adikoda is a 25-&ear !ife scieces id)str& vetera ad has p)b!ished ad preseted more tha F0 artic!es i peer-revie+ed #o)ra!s ad iteratioa!
cofereces o topics i g!oba! !abe!ig* medica! imagig* c!iica! tria! data maagemet/disc!os)re* ad techo!og& i the !ife scieces. 5e is 4/9/-o)der of Jirtif&* 3c.*
a iformatio maagemet so!)tio compa& for !ife scieces. ;rior to Jirtif&* .r. %adikoda +as the fo)der of %ribios&s* 3c.* ad 4/9 of /med* a c!iica! tria! ad
data maagemet s&stems compa&. .r. %adikoda ho!ds a .octorate i /!ectrica! ad 4omp)ter /gieerig from the Hiversit& of 3o+a* ad a Dache!or of %echo!og& i
/!ectrica! ad /!ectroics /gieerig from Dir!a 3stit)te of %echo!og& ad @ciece* 3dia.
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