clinical trials workshop & summit 2015

KEYSPEAKERSINCLUDE:-

K.Bangarurajan,Dy.DrugsController(I)CDSCO,

ArunBhatt,President,

BhaswatS.Chakraborty,SeniorVP,R&D,

AmitArora,HeadMedicalAffairs,

AshwaniPandita,HeadQualityManagementandTraining,GlobalClinicalResearch Operations,

KedarSuvarnapathaki,Head-RegulatoryAffairs,

ChiragTrivedi,Director&HeadofClinicalStudyUnit,

BabitaKirodian,HeadofCountryPharmacovigilance,

KavithaIyerRodrigues,Director,COO,

PratikShah,Head-Clinical,Medical&RegulatoryAffairs,PVandQA,

JyotsnaPatwardhar,HeadDevelopmentQA,

MazharMaruf,RegionalHeadofPharmacovigilance-AsiaPacific,

SujaySalvi,Head,ClinicalTrialSuppliesManagement,

ChitraBargaje,Consultant,

V.K.Sharma,AssociateVicePresident,

MilindAntani,Head-PharmaLifeSciences,

DeeptiSanghavi,SeniorMedicalWriter-MedicalWriting,

DCGI

ClininventResearch

Cadila

MerckSerono

Glenmark

BoehringerIngelheim

SanofiAventis

BristolMyersSquibb

TheramytNovobiologics

AstellasPharma

Novartis

Glenmark

SIROClinpharm

ADAMASConsulting

UnichemLaboratories

NishithDesaiAssociates

SIROClinpharm

PlusManyMore...

ConferenceHashtag-#VI_Pharma

ORGANIZEDBY

GOLDPARTNER

SUPPORTEDBY

ASSOCIATEPARTNER

WORKSHOPPARTNER

6thAnnualClinicalTrialsSummit2015

28th&29thMay2015,KohinoorContinentalHotel,Mumbai,India

CONFERENCEINTRODUCTION:-

TheInternationalRegistryofClinicaltrials,thedatabankmaintainedbytheNIHinU.S.(clinicaltrials.gov),hasaround203,394trialsbeingcarriedoutworldwide.As

perthisregistry,thenumberoftrialscarriedoutinIndiaisonly3043,whichis40%ofallglobaltrialsarecarriedoutintheU.S.Chinahasregistered17198trials(>8%),substantiallyhigherthanIndia.Thefearthatthereis

anavalancheoftrialsmovingouttoIndia,riskingourpopulationtotrialdrugsisthusunfounded.AsofnowIndiaisbynomeansapreferredhubforclinicaltrials,but

thethepotentialtobecomeone,inviewofmanyfavourablefactors,suchasstate-of-the-artskillsofinvestigators,levelofqualityhealthcareinstitutions,the

availabilityofpatientpopulationswithdiversegeneticpools,languageadvantageandinformationtechnologybasedanalyticaltools.

TheeventsofthelasttwoyearswhichseverelyaffectedtheclinicaltrialscenarioinIndiamayhaveevenconsolidatedandtightenedthesystemtobringinmore

transparencyandqualityassurancewhichwillenhancethecredibilityofIndianeffortsinthearea.Whatisrequiredisasystematic,timeboundregulatoryevaluation

andapprovalsystemforallphasesoftrialsandbetterandtransparentcommunicationbetweenthestakeholdersandtheregulatoryagency.Withoutnewdrugs

discovery,muchofthediseaseproblemsoftheworldwillremainunattendedandneglected.Thenewgovernment,inoneofitsearlypolicystatementshademphasized

theneedtoencourageproperlyconductedclinicaltrialsinIndiawithappropriateregulatorycontrols.Itisferventlyhopedthatrealisingtheimportanceofthissegment

inNewDrugDiscoveryResearch,theconcernedauthoritieswilltakeapragmaticviewandthroughtimeboundandmorediligentapprovalprocessesencourageclinical

research.

6thannualclinicaltrialssummit2015willexaminethecurrentissuesfacedinclinicaltrialsoperations,addressingtherisks,timelineandbudgetstipulations,while

effectivelytacklingkeychallengesinovercomingtrialsagreementandsitecontractarbitrationproblems.Thissummitwilldiscusstheoperationalelementoftrialsite

management,strategicpartnershipwithCROsandSMOs,patient,talent&investigatorsmanagementinordertoimprove&optimizetheoveralldrugdevelopment

effectivenessandROI.Thisconferencewillbesharedby leadingindustrialpractitionersacrosstheregiontopromotepracticaldiscussions;especiallyontheknow-how

tomanageneeds,variabilityofdifferentcountriesandinstitutionstoenhanceclinicaloperationalexcellenceandvigilance.Attendeeswillhavethechancetolearn,

networkandbenchmarkagainsttheglobaltoppharmasandlocalindustryleadersonthebestpracticesintalent,site,budgetandperformancemanagementinclinical

trials.TheconferenceaimstoprovideadetailedanalysisofwhatittakestoconductclinicaltrialsfromabiopharmaceuticalsandvaccinesperspectiveinIndiaandalso

addressingrisk/benefitbalance,anecdotalexperiencesofthemultinationalpharmaceuticalindustryinIndiaandotherpartsofAsia,selectionandroleofCROs,logistics

ofoperations,clinicaltrialsmanagement,governmentpoliciesandpharmacovigilance.6thannualclinicaltrialssummit2015willprovideyouwiththedatathatyou

needtorecognizethiscomplexandrapidlyexpandingsector.Knowingthefuturemarket,andwhatimpactswillthathasonfuturebusinessopportunities?Thisisyour

opportunitytostayaheadbylearningthelatesttrendsandnetworkingwiththetrendsetters.

Itgivesusimmensepleasureinwelcomingyoutothe .Iwishandpraythatalloureffortswillbebeneficialtoourindustries

andtoourcountryatlarge


Updateyourselfwithrespecttotermsoflegislation,policies,systems,technology,communicationstrategiesandbestpractices

Determiningthestepsandstrategiesforenhancingqualityinhealthcare

DiscoveringthenewtrendsinglobalclinicaltrialsandtheirroleinIndia

Technologiesthatdriveefficienciesinglobalclinicaltrials

StrategiestoconductsuccessfulinterventionaloncologytrialsinIndia

Qualitybydesign

Monitoring,managingandleadingclinicaltrials:Anintegratedapproachforbettertrialsuccess

Maintainingproperbalanceinrelationships:Sponsor Site CRO&Patients

Marginofsafety:IdentifyingidealclinicalsitesandstrategizingpatientrecruitmentandclinicalsitesmanagementinIndiatodevelopappropriateclinicalstudies

EffectivelyincorporatingGCP&GCPs KnowingwhatTO-DOandwhatNOTTO-DO

Re-Thinkingpatientrecruitmentandpatientexperience

FindingtheidealpartnerinoutsourcingyourlogisticsoperationsinIndiahowtoidentifysmartpackagingsolutionstobalancequalityandcosts

IdentifyingthedecisioncriteriaforpartneringwiththerightvendorsinAsia

Howtomanagerisksinclinicaltrialseffectivelyandhowtosuccessfullyincorporaterisksharingmodelsinclinicaltrials

Avoidingmistakesindatacollectionandensuringprofitabilityandtounderstandthelongtermoperationstrategiesformanagingclinicaltrials.

Overcomingchallengesfacedinregulatoryapprovalprocesses obtainingdrug/clinicalsuppliesimportandexportlicensesinAsia

RegulatoryreviewatthedrugscontrollergeneralofIndia(DCGI)andcentraldrugsstandardcontrolorganization(CDSCO):science,quality,andspeed

Analyzingtherecentgovernmentrulesandguidelines

Nextgenerationsofclinicaltrials Howbigwillthemarketbe?

Bepartofamajornetworkingopportunity

TARGETAUDIANCE-INDUSTRY:-

Pharmaceuticalorganisations,Genericpharmaceuticalcompanies,Contractresearchorganisations,Patientrecruitmentcompanies,Government-Departmentofhealth,

Non-profitorganisations/Association,Consultants

WHOSHOULDATTEND:-

CEO's,CTO's,CIO's,Presidents,VicePresidents,DirectorsHeads&Managersof: ClinicalResearch&Development,ClinicalResearchServices,ClinicalOperations,ClinicalDataManagement,ClinicalIT,ClinicalTrials,MedicalAffairs,RegulatoryAffairs,Compliance,Qualitycontrol/Assurance/GCP,ClinicalStudyDesign,

SafetySurveillance,SubjectRecruitment,E-ClinicalSystems.

WHYSHOULDYOUATTEND:-

Getmorefromtheevent,withabroaderscopebringing

thewholecommunicationsvaluechaintogether.Enjoyandmakethebestoutofourdedicatednetworkingdrinkstime,meettheleadinginternationalvendorsexpand

yourknowledgeofthelatestbusinessmodelsandstrategiesinthehigh-levelconference.Showcasingtheproductsoftomorrowintheco-locatedexhibition.

6thAnnualClinicalTrialsSummit2015- -Acriticalguideforsuccessfullyconductingclinicaltrials

KEYTHEMESDISCUSSEDATTHISSUMMIT:-



08:30 Coffeeandregistration

09:30 Chairpersonopeningremarks

09:40 IndianClinicalTrials:Currentchallengesandfuturefocus

10:10 Clinicaltrialoutsourcing:Concernsandguidelines

Anopportunitytomeetandto

networkwithyourconferencecolleagues.

EvolvingIndianRegulatoryscenario

ChallengestoIndia'spotentialinclinicalresearch

Focussingthefutureonfundamentals

StatusofIndiaincurrentglobalclinicalresearchmarket

ConductingclinicaltrialsinIndia

Latestguidelines&scrutinizingforinvestigators

PossibleremediesforIndianmarkettomatchregulatory

guidelines

industry

10:40 MorningCoffee/Tea&Discussion


ArunBhatt,President,

UnichemLaboratories

ClininventResearch

(https://www.linkedin.com/pub/v-k-sharma/23/ba/197)

MorningKeynoteAddress1:

MorningKeynoteAddress2:

(https://www.linkedin.com/pub/arun-bhatt-dr/4/9bb/658)

HowtoimprovequalityassuranceinIndianclinicalresearch

11:40 Riskbasedapproach

12:10 ClinicalResearchinPractice

Onsiteandremotemonitoringapproaches

Recurrentrisksandmitigationthroughmonitoring

Quality-by-design

Riskmanagementandriskminimization

Riskminimizationeffectivenessmeasurement

Clinicaldevelopmentandoperations

InIndiaforIndia,Asiaandtheworldcomparativeeffectiveness

research

Integratevariousclinicaltrialsystemstoimprovedataquality

GCPandGCRP

11:00 KeynotePanelDiscussion:ChallengesandOpportunitiesfornowandfuture

Moderator:

Panellists:

Whatarethecurrentproblemsfacedintodaysmarketandhowto

successfullyovercometheminthishighlycompetitivemarket?

Whichemergingmarketsarehottesttoday?

Offshoring-Balancingtherightopportunitiesandrisks

Whatmakeseachmarketuniqueandhowdomarketscompare?

Successfulbudgetdevelopment&analysis-Howdosponsors

developstudybudgets?Howdositespricetheirservices?

Recruitmentandretentionofpatients


BhaswatS.Chakraborty,SeniorVP,R&D,

KavithaIyerRodrigues,Director,COO,

UnichemLaboratories

Cadila

TheramytNovobiologics

(https://www.linkedin.com/pub/v-k-sharma/23/ba/197)

(https://www.linkedin.com/pub/bhaswat-chakraborty/18/34/27)

(https://www.linkedin.com/pub/kavitha-iyer-rodrigues/b/b29/8b8)

MARKETOVERVIEW&ANALISYS

CHALLENGES&OPPORTUNITIES

RMP

12:40-Networking -Takeyourdiscussionsfurther&buildnewrelationshipsinarelaxed

&informalsetting...

luncheon

SPONSOR SITE CRO-PATIENTS

14:00-AfternoonKeynotePanelDiscussion-Maintainingproperbalanceinrelationships:Sponsor Site CRO&Patients

Moderator:

Panellists:

Four-wayrelationshipbetweensponsors,sites,CROs&patients-

Realisticexpectations,clearcommunications,shared

understandings,practicalpolicies,andefficientproblemresolution

Quantitativeanalysisrevealsrapidchangesintheindustryand

trendsforthefuture.Howcansponsors,sitesandCROsmeetthe

challenges?

Choosingapartnerwhocantakenecessarystepstorectifythes

ituationwhenthingsgowrong

Understandingsponsorsprincipleforselectingthelocalclinical

researchorganization

Identifyingtheanticipatedadvantagesofacollaborativeclinicaltrial

allianceforgreaterefficiencyandcostreduction

Whatarethecurrentperspectivesonthefutureofoutsourcingin

Asia?

AmitArora,HeadMedicalAffairs,

AshwaniPandita,HeadQualityManagementandTraining,GlobalClinicalResearchOperations,

SujaySalvi,Head,ClinicalTrialSuppliesManagement,

MerckSerono

Glenmark

SIROClinpharm

(https://www.linkedin.com/in/arora007)

(https://www.linkedin.com/pub/ashwani-pandita-rqap-gcp/14/997/590)

(https://www.linkedin.com/pub/sujay-salvi/5/73b/82a)

DAY1-28thMAY2015



15:20 AfternoonTea/Coffee

15:40 Monitoring,managingandleadingclinicaltrials:Anintegratedapproachforbettertrialsuccess

Clinicalresearchstaffshouldunderstandthedifferencebetweentactileexecutionandstrategicexecutioninclinicaloperations

Itisimportanttogainnewinsightsintoanintegratedrolewhichaddressesmanyunmetneedsofaclinicaltrial

The'NextGenerationClinicalResearchProfessionals'shouldadapttotheirnewrolebylookinginsidetofacetheoutside

Clinicaltrialsuccessdependsgreatlyoncreatingandnourishingacollaborativeandlearningcultureinthisnewrole

16:50-Chairpersonsclosingremarksandendofconference



14:40-PanelDiscussion-Marginofsafety:IdentifyingidealclinicalsitesandstrategizingpatientrecruitmentandclinicalsitesmanagementinIndiatodevelopappropriateclinicalstudies

Moderator:

Panellists:

Toimplementcorrectsafetyandhealthymeasures.

Ensuringsecurityofclinicaldataandnon-disclosure.

Challengesforqualityassuranceinclinicaltrials.

Usingpharmacovigilancedatabasestofacilitatethedetectionof

adverseeventsandthegenerationofsafetysignals

ExamininginformationprovidedinIndividualCaseSafetyReports

(ICSRs)todeterminewhetherasignalshouldbeinvestigatedor

not

Start-upteamstomanageclinicaltrials:advantagesand

limitations

DeeptiSanghavi,SeniorMedicalWriter-MedicalWriting,

ChiragTrivedi,Director&HeadofClinicalStudyUnit,

PratikShah,Head-Clinical,Medical&RegulatoryAffairs,PVandQA,

JyotsnaPatwardhar,HeadDevelopmentQA,

ChitraBargaje,Consultant,

SIROClinpharm

SanofiAventis

AstellasPharma

Novartis

ADAMASConsulting

(https://www.linkedin.com/pub/dr-deepti-sanghavi/5/591/b76)

(https://www.linkedin.com/pub/dr-chirag-trivedi/21/b0/344)

(https://www.linkedin.com/in/drpratikshah)

(https://www.linkedin.com/in/chitrabargaje)

QUALITY-SAFETY-SIGNALDETECTION Moderator:

Panellists:

MilindAntani,Head-PharmaLifeSciences,

K.Bangarurajan,Dy.DrugsController(I)CDSCO,

MazharMaruf,RegionalHeadofPharmacovigilance-AsiaPacific,

KedarSuvarnapathaki,Head-RegulatoryAffairs,

BabitaKirodian,HeadofCountryPharmacovigilance,


DCGI

Glenmark

BoehringerIngelheim

BristolMyersSquibb

(https://www.linkedin.com/in/milindantani)

(https://www.linkedin.com/pub/dr-mazhar-maruf/b/303/2b5)

(https://www.linkedin.com/pub/kedar-suvarnapathaki/4/954/765)

(https://www.linkedin.com/profile/view?id=37647503)

17:00-18:00-Networking -Takeyourdiscussionsfurther&buildnewrelationshipsina

relaxed&informalsetting...

Drinks

REGULATORY

16:10 PanelDiscussion:Thedevelopingregulatoryframeworkinadvancedanddevelopingmarkets forToday&Tomorrow

AdaptingtoIndiastransformedregulatorylandscapestoconduct

clinicaltrials

Abriefrecapofrecentregulatorydevelopments.Ensuringyou

complywithmarketrequirements

WhatistobelearntonhowIndiancompaniescanworkin

harmonywiththeRoWlegalframeworks

EffectivelyincorporatingGCP&GCPs KnowingwhatTO-DOand

whatNOTTO-DO


28th 29thMay2015,KohinoorContinentalHotel,Mumbai,India&

A2020VisionforClinicalResearchInIndia

WorkshopLeadersFrom

(TBC)

09:00-10:00Coffee&Registration

10:00-16:00Workshop

TimingIncludesLunchandRefreshmentBreaks

ABOUTVIRTUEINSIGHT-

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WorkshopAgendaand

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ABOUTMEDIDATA-

Weprovideinnovativeclinicaldevelopmentsolutionsthatsafelyand

efficientlyimprovequalityoflife.Weprovideourcustomerswitha

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FormoreInformation,visit: http://www.mdsol.com/

DAY2-29thMAY2015

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AttendeesfromourpreviousClinicalTrialsConferenceAbbott

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BioSpectrum

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AssistanceCouncil

BoehringerIngelheim

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BusinessVibes

C.L.A.I.M.S

Cadila

CambridgeResearch&

Instrumentation

CanBiotech

CCRT

Cipla

ClinicalDiagnosticCentre

Clinigene

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CoffeeDay

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CSC

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DiagnoSearchLifeSciences

Dr.Reddy'sLaboratories

ECCROIndiaServices

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ExpressPharma

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G7SYNERGON

GenericLicensing

GlaxoSmithKline

Glenmark

GlobalData

GlobalHealth

GoingToMeet

GVKBio

HCLTechnologies

HeartCareAssociates

HindujaHospital

HindustanTimes

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ICRI

ImageCoreLab

InbioproSolutions

IndianAcademyofClinicalResearch

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ITS-DCHRC

JAICAsiaHoldings

JameJamshedWeekly

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JohnsonandJohnson

JubilantClinsys

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LambdaResearch

LinkpingUniversity

LupinBioresearchCenter

Marken

MediStatsLab

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MMSHClinicalResearch

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Novartis

NovartisHealthcare-VaccinesDivision

OcasaLogisticSolutions

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OviyaMedSafe

PanaceaBiotec

ParadigmIT

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PRAInternationl

ProvenanceResearch

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Quintiles

RegPakBioPharmaConsulting

RelianceLifeSciences

RubiconResearch

RubyHallClinic

SPSoftwareTechnologies

SanofiPasteur

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SenceCR

SerumInstituteofIndia

SGDS.AGlass

SIROClinpharm

SolonistBusinessSolutions


SRL

SRLDiagnostics

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Strides

TCS

TechObserver

TechTree

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Templegate

ThePharmaWorld

TorrentResearchCentre

U.S.Embassy

Unilever

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UntilRoi

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VeedaClincialResearch

VerGoPharmaResearch

VoisinConsulting

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VPH

WatsonPharma

WesternInstitutionalReviewBoard

Witness

Wockhardt

WorldPharmaToday

YCLIN

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A.Menarini

Abbott

AbbottNutritionR&D

Acceliant

Accutest

ACGAssociatedCapsules

ACMGlobalCentralLaboratory

AETLaboratories

Alcon-GlobalClinicalSite

Management

AlkemLaboratories

AllerganHealthcare

Antara

Apotex

AstellasPharma

AstraZeneca

AtharvaLifesciencesConsulting

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AurigeneDiscoveryTechnologies

AzidusLaboratories

BangaloreDiabetesHospital

Baxter

Bayer

BeroeConsultingIndia

Bilcare

BioconFoundation

BioSpectrum

BiotechnologyIndustryResearch

AssistanceCouncil

BoehringerIngelheim

Bristol-MyersSquibb

BusinessVibes

C.L.A.I.M.S

Cadila

CambridgeResearch&

Instrumentation

CanBiotech

CCRT

Cipla

CityXRay&ScanClinic

ClinicalDiagnosticCentre

Clinigene

Cliniminds

ClininventResearch

CliniSearch

ClinitrialsResearch

Clinnex

ClinOmaHealthcare

ClinTrialsResearch

CoffeeDay

CognizantTechnologies

CrescentScientific

CSC

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DBMSConsulting

DCGI

DiagnoSearchLifeSciences

Dr.Reddy'sLaboratories

ECCROIndiaServices

EcronAcunova

EliLilly

EMCCorporation

EtykaClinicalSolutions

ExpireHealthResearch

ExpressPharma

FamyCare

ForteResearchSystems

FortisClinicalResearch

FreseniusKabi

G7SYNERGON

GenericLicensing

GlaxoSmithKline

GlenmarkPharmaceuticals

GlobalData

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GoingToMeet

GovernmentofVictoria,Australia\

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GSK

GVKBio

HCLTechnologies

HeartCareAssociates

HindujaHospital

HindustanTimes

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ICRI

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IndianAcademyofClinicalResearch

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Interveinlaboratories

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JohnsonandJohnson

JubilantClinsys

KAPComputerSolutions

KarmicLifesciences

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LinkopingUniversity

LotusLabs

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Marken

MedantaDukeResearchInstitute

MediStatsLab

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IndianBank

118-119,IndiraNagar,Valasaravakkam,

Chennai600087,Tiruvallurdistrict,TamilNadu,India

EarlyBirdDiscountRateTill17thApril2015

StandardRate-Applicableafter17thApril2015

MethodsofPayments:

ByCheque-

ByBankTransfer:

AccountName-AccountNumber-SortCode-BankAddress-

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onferenceonly-Fee:INR05,000+Tax

Conference&Workshopfor1or2delegates/D

Conferenceonlyfor1or2delegates/D-Fee:INR06,000+Tax

Conference&Workshop-3&abovedelegates-/D-Fee:INR06,000+Tax

ConferenceOnly-3&abovedelegates-/D-Fee:INR05,000+Tax

2Daysconference&Workshop/D-Fee:INR08,000+Tax

GroupBookings

SpotRegistration:-

clinical trials workshop & summit 2015

Documents