IM_Regulatory Information Management2

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Regulatory Information Management: New Technologies ToImprove 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 ,* ,* ad other reg)!ator& bodies are epadig ad amedig re)iremets* c!iica! tria!s are becomig more comp!e* ad

p)b!ic disc!os)re demads are icreasig. %his icreases the importace* comp!eit& ad risk re!ated to maagig reg)!ator& iformatio assets.

,ccordig to aa!&st firm 3 ea!th 3d)str& 3sights* a e+ dr)g costs from 800 mi!!io to 1.2 bi!!io to brig to market* ad a )arter of this cost is reg)!ator&

cotet re)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* reegi eerig of ke& processes* e+ mode!s of parterig ad o)tso)rcig ke&

deve!opmet activiti es to s. %hese moves to a more agi!e eterprise m)st ot be hobb!ed b& c)mbersome reg)!ator& iformatio maagemet (3$ paradigms based

o !egac& thikig ad s&stems.

%his artic!e +i!! ep!ore e+ 3 approaches ad techo!ogies for better maagemet of ad access to reg)!ator& iformatio. eg)!ator& data ad the re!ated iformatio

are importat corporate assets* s)pportig ma& cross-f)ctioa! processes s)ch as ma)fact)rig* 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

eg)!ator& professioa!s (;$ face a shiftig !adscape +hi!e str)gg!ig +ith pro!iferatig iformatio so)rces* variab!e data )a!it& ad heterogeeo)s data. %oo ofte

iformatio maagemet strategies ad s&stems are ot desiged to cross orgaireg)!ator&? activities. eg)!ator& professioa!s eed visibi!i t& 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. a& fee! the prob!ems ac)te!& at partic)!ar if!ectio poits A a epadig prod)ct portfo!io* s)bmissio

dead!ies* or geographic epasio. %he& the recogi


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Ge& reg)!ator& iformatio sho)!d be gathered ad preseted i ro!es-orieted (e.g. ec)tive* eg)!ator&* * 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 chages.

ach activit& is tracked ad maaged. =ith commitmets* for eamp!e* the ; ca moitor a!! ob!igatios to hea!th a)thorities ad be otified of )pcomig re)iremets.

;s sho)!d epect a fi!ig p!a maagemet abi!it& for s)bmissios from iceptio to ed. %his ic!)des creatig the iitia! p!a* gatherig re)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. ;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 ;s so)rce data ad coordiate activities across m)!tip!e departmets ic!)dig eg)!ator& ,ffairs* * @)pp!&* ommercia!* 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. ,;,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 eamp!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


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@tr)ct)red cotet maagemet ca he!p the reg)!ator& professioa! respod to s)dde evets. or eamp!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 ; a)to-geerated the re)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 ; 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!e reg)!ator&

ad cotet re)iremets of the dr)g prod)ct !ife c&c!e* !eadig to faster market peetratio at !o+er cost.

A"out the Authorr. @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. e is /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 of med* a c!iica! tria! ad

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!ectrica! ad !ectroics gieerig from Dir!a 3stit)te of %echo!og& ad @ciece* 3dia.

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