VIBpharma

WHy yOU SHOULD ATTEND?: Improve • your long-term clinical development strategies by understanding how to maximise opportunities in emerging markets

Identify • challenges with site selection and patient recruitment and discover eff ective methods to overcome them

Discover • channels where you can improve your off -shoring strategy and make the most of opportunities for conducting trials in emerging countries

Uncover • the pros and cons of importing and exporting drugs and biological samples in order to save money on your operations

Monday 1 – Tuesday 2 March 2010, Prague, Czech Republic

Sliversponsor:

2ndAnnual

Clinical Trials in Emerging MarketsMaximising the opportunities forglobal clinical development

DISTINGUISHED SPEAKERS INCLUDE:Anish Desai, HeadR&DandMedicalDirector,BAyER HEALTHCARE INDIA

Ramil Abdrachitov, ClinicalResearchManager,ClinicalResearchRegionCentralandEasternEurope–RussianDepartment, ASTRAzENECA

Pavel Farkas, SeniorDirector,Biopharmaceutics,PLIVA CROATIA

Jörg Möller, SeniorVice-PresidentHead,GlobalClinicalDevelopment, BAyER SCHERING PHARMA

Eric Hurden, AssociateDirector,GlobalClinicalOperations,BIOGEN IDEC

Josemund Menezes, ClinicalProjectLeaderandMedicalAdvisorCRU–India, SANOFI AVENTIS

Eva Lapkova, ClinicalMonitoringManagerforCzechRepublic,SlovakiaandHungary, MERCK

Cem Ozesen, ClinicalResearchManager,MERCK

Sliversponsor:

Attendto network withover 50 leadingpharma and biotech companies fromaroundthe world

REGISTER NOW:■ Online: www.clinicaltrialsevents.com/emerging-markets/register ■ Tel: +44 (0)20 7753 4268■ Email: book@arena-international.com ■ Fax: +44 (0)20 7915 9773

Programme day one Monday1March2010

Upgradingethicscommitteestogovernalllocaltrialsites ●

Sitemanagementorganisationandmaximising ●

patient recruitmentRetainingtalentinanincreasinglycompetitive ●

trial environmentCapacitybuildingattheclinicalsitesandreducing ●

patientdrop-outratesOvercominginfrastructurerestrictionsandidentifying ●

the best strategy for advancing clinical trialsJosemund Menezes, Clinical Project Leader and Medical Advisor CRU – India, SANOFI AVENTIS

12:10 Infrastructure challenges in conducting trials in IndiaDealingwiththelackofprocessesandsystemsinregardsto ●

communication and conducting clinical trials abroadFindingadequateclinicalfacilitiesandtrainedclinical ●

investigatorsOvercomingregulatorybarrierstoentryinsiteselection ●

Ensuringadequaterecordkeepingonpaperandavailable ●

electronic databasesViraj Rajadhyaksha, Senior Manager, Operations, Planning and Management Clinical Research, PFIzER INDIA

12:40 Lunch

PRACTICAL AND ETHICAL CHALLENGES IN EMERGING MARKETS14:00 Feasibility studies for informed decision making

when conducting clinical trials in emerging regionsAdequatecountryselectionandpatient ●

recruitmentprojectionsFacilitatingthedecisionmakingprocessthrougha ●

analysis of optionsStartupchallengesandavoidingdelaystostudyprogress ●

Evaluatingthebenefitsofemergingmarketscompared ●

to developed countries Thebenefitsoftakinganonsurveyapproachtofeasibility ●

Costbenefitanalysistorevealthefullextentofthepros ●

and consEric Hurden, Associate Director, Global Clinical Operations, BIOGEN IDEC

14:30 When and how to conduct a successful clinical trial in an emerging clinical research countryKeydecisiondriverssupportingtheconductof ●

your trial abroadManaging cultural differences and minimising ●

risksoferrorsEnsuringthateverysitecomplieswithbothlocal ●

and global ethics board Choosingtrialpartnersthroughanalysisofethical ●

andGCPcompliancePatient recruitment considerations for building a ●

sustainable trial environmentSustaininglocalaccesstotreatmentsfoundtobe ●

safe and effectiveCem Ozesen, Clinical Research Manager, MERCK

15:00 Panel Discussion: Choosing the right trial partner through an efficient and thorough selection processSettingaselectioncriteriatofindtherightqualitypartner ●

Information gathering processes to determine partners ●

capabilities and strengthsUnderstandingcompetenciesandtrackrecordsin ●

chosen trial sitesAgreeingtorobustcontractsthatcoverallstudyareas ●

8:30 Registration9:00 Opening remarks from the Chair

Eric Hurden, Associate Director, Global Clinical Operations, BIOGEN IDEC

PROJECT AND SITE MANAGEMENT SOLUTIONS FOR OFFSHORE TRIALS9:10 Getting the site selection right to achieve

optimal study outcomesEnsuringthatsponsorsunderstandtheprosandcons ●

of each site locationDetermining ways to access to patient population and ●

maketherecruitmentprocesseasierUnderstandingtheregulatoryapprovalprocesses ●

Establishingarelationshipwithlocalauthorities ●

Understandingthebenefitsofchosensitesforlongterm ●

trial sustainability and patient retentionRamil Abdrachitov, Clinical Research Manager, Clinical Research Region Central and Eastern Europe – Russian Department, ASTRAzENECA

9:40 Non-invasive monitoring and management of global trialsGivingCROsflexibilitywhilstensuringthebestuseof ●

resources are met and there are minimal delaysMaintaining ongoing communication to identify ●

problems earlyEnsuringkeydeliverablesandtimelinesaremet ●

Understandthepracticalitiesofvendormanagementin ●

offshore trial sitesMakingthedecisionforkeepingprojectmanagement ●

in-houseoroutsourcetoaserviceproviderOlav Flaten, Medical Director, GSK

10:10 Panel Discussion: Setting up metrics for trials in emerging countriesDeveloping performance metrics that are appropriate to the ●

circumstances and meet the challenges of the trialAdaptingexistingmeasuresoncetrialsitesarechosen ●

Determining all variables that can affect a trial to assist with ●

minimisingriskVariations in metrics for different trial sites ●

10:40 Morning Refreshments

MAXIMISING OPPORTUNITIES AND OVERCOMING CHALLENGES IN INDIA AND ASIA-PACIFIC11:10 Keynote presentation: Clinical development in

emerging markets: the case of the Asia-Pacific regionUnderstandingcurrentregulatoryandlegalaspects ●

of the regionDeveloping your strategy for complying regulations ●

and communicating with regulatory bodiesSuccessfullynavigatingtheapprovalprocess ●

Determiningtherestrictionsonimportingandexporting ●

of drugs and biological samplesDealing with ethics committees ●

Jörg Möller, Senior Vice-President Head, Global Clinical Development, BAyER SCHERING PHARMA

11:40 Maximising the benefits of the growing market for trials in IndiaThebenefitsofhighqualitymedicalstaffandanincreasingly ●

professionalregulatoryframeworkDevelopment in regulations and reviewing the benefits of ●

setting up clinical trials in India

Programme day Two Tuesday2March2010

8:30 Registration

9:00 Opening remarks from the ChairPavel Farkas, Senior Director, Biopharmaceutics, PLIVA CROATIA

09:10 Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of data management

Roundtable 1Ethical considerations of conducting trials in emerging markets

Understandinglocalregulationsandoperatingwithin ●

guidelines to ensure compliance ethical codes of conductCem Ozesen, Clinical Research Manager, MERCK

Roundtable 2Advantages and challenges of conducting trials in Eastern Europe

Navigatingobstaclesintrialsetupandprojectmanagement ●

in core trial sitesRamil Abdrachitov, Clinical Research Manager, Clinical Research Region Central and Eastern Europe – Russian Department, ASTRAzENECA

Roundtable 3Maximising the benefits of clinical trials in Asia

Identifyingsuitablelocationsandworkingwithlocal ●

authorities to facilitate trial conductLesley Mathews, Strategic Sourcing Manager, BAyER HEALTHCARE

Roundtable 4Identifying opportunities in the Asia-Pacific region for cost effective clinical development

Makingthemostofavailableresourcesandexpertise ●

in the regionJörg Möller, Senior Vice-President Head, Global Clinical Development, BAyER SCHERING PHARMA

Roundtable 5Developing and maintaining successful a relationship between trial sponsors and service providers

Building trust and agreeing measureable outcomes for trials ●

in unfamiliar territoriesPavel Farkas, Senior Director, Biopharmaceutics, PLIVA CROATIA

Roundtable 6Managing patient expectations and implementing a successful patient recruitment and retention strategy

Maximisingtheopportunityforpatientrecruitmentand ●

maintaining the long term viability and success of the trialOlav Flaten, Medical Director Norway, GSK

12:40 Lunch

Minimisingthetimetakenforpartnerselectiontoreduce ●

overall cost of clinical trialsEstablishingarelationshipoftrusttogetthetrialofftothe ●

best start

15:30 Afternoon refreshments

CASE STUDIES FROM CENTRAL AND EASTERN EUROPE16:00 Making the most of clinical trial hubs in the Czech

Republic, Slovakia and HungaryStrategicissuesandconsequencesforkeytrialdecisions ●

Developing awareness of different regulations, licensing ●

environments,patientpopulationsandexpectationsBuildingtheexpertiseamongstclinicalinvestigatorsto ●

successfully set up and run trialsConsiderationsforsponsorswithlimitedexperiencein ●

CentralandEasternEuropeforsettingupclinicaltrialsEva Lapkova, Clinical Monitoring Manager for Czech Republic, Slovakia and Hungary, MERCK

16:30 Overcoming cultural and communication barriers when conducting trials in Eastern EuropeTailoringprojectmanagementandcommunication ●

processes for offshore trialsMatchingpatientexpectationswithrecruitment ●

processes for different sitesThechallengeofworkingwithdifferentbureaucratic ●

bodies and regulatory processesCommunicationtechniquestosecureco-operationfrom ●

authorities without delaying trial set up processesAgreeingclearandmeasurableoutcomes,timelines, ●

costsandexpectationswithlocaltrialpartnersandrecruitingadequatelyskilledstaffMikhail Putilovskiy, Clinical Operations Manager, ELI LILLy RUSSIA

17:00 Closing remarks from the Chair and close of Day One

Register online now at: www.clinicaltrialsevents.com/emerging-markets/register

Programme day Two Tuesday2March2010

14:00 The challenges and benefits of conducting trials in the Czech RepublicReviewingthechallengesofsettinguptrials ●

Designingtrialstructurestotakeaccountoflocal ●

infrastructure and site constraints Understandingtheregulatoryissues ●

Makingthemostofpatientrecruitmentopportunities ●

MaximisingdrugdevelopmentintheCzechRepublic ●

Petr Cypro, Medical Director, BRISTOL MEyERS SqUIBB

LONG TERM STRATEGIES FOR CLINICAL DEVELOPMENT14:30 Panel discussion: The sustainability of global

studies in emerging marketsDetermining the long term value of conducting ●

trials in emerging countriesAssessingoutsourcingdecisionsonthebasisof ●

quality,costandmeasurableoutcomesAnticipatingcostincreasesinarapidly ●

professionalising and competitive trial arenaRobustqualityassuranceframeworkstodetermine ●

value for moneyAscertainingthelongtermeffectivenessof ●

offshoring strategies

15:30 Afternoon refreshments

INDIA: COMPETING IN A GROWING MARKET FOR CLINICAL DEVELOPMENT15:30 Recruiting trained CRAs and investigators in a

competitive Indian marketFindingthemostqualifiedprofessionalsasthe ●

number of trials increaseSettingthecriteriaforstaffrecruitmenttoensure ●

appropriatelevelsofexperienceandexpertiseWorkingwithclinicaltrialtraininginstitutestosupply ●

qualifiedprofessionalsStaffretentioninthefaceofintensecompetition ●

between trial sponsorsMakingthemostoftheprofessionalisationinthe ●

industry to reduce trial errorsThe long term clinical trial strategy for emerging countries ●

Anish Desai, Head Research and Development and Medical Director, BAyER HEALTHCARE INDIA

16:00 Conducting clinical studies for generic pharmaceuticals in India: a global sponsor's viewDealingwiththelackofprocessesandsystemsfor ●

communication and conducting clinical trialsFindingadequateclinicalfacilitiesandtrainedclinical ●

investigatorsOvercomingregulatorybarrierstoentryinsiteselection ●

Ensuringadequaterecordkeepingonpaperand ●

available electronic databasesPavel Farkas, Senior Director, Biopharmaceutics, PLIVA CROATIA

17:00 Closing remarks from the Chair and close of conference

PosT-conference workshoP

Successful CRO selection and monitoring processes when conducting trials in emerging marketswednesday 3 March 2010led by: roger Joby, Managing director, 1to1to1

About the workshop:Choosingtherighttrialpartnerisacrucialsteptowardsbuildingasuccessful clinical trial model but trial sponsors must have a clear vision of trial aims and communicate this effectively to partners throughout theselectionprocessandtheconductoftheclinicaltrial.Knowingyourgoalsmakesiteasiertomakedecisionsonselectioncriteriaandcarryoutassessmentsofthestrengthsandcapabilitiesofpotentialpartners.

Having made the decision on your trial partner, the importance of contractnegotiationandsubsequentprojectmonitoringisparamountinordertoachievethegoalsofthetrialontimeandonbudget.ThisworkshopprovidesapracticalandinteractiveenvironmentinwhichtoengagewiththechallengesofCROselectionandmonitoring.Itisintendedtoenabledelegatestoshareexperiencesofselectionstrategies,contractplanningandtrialmonitoring.

Workshop agenda:9:00 Registration and coffee

9:30 Effective planning for making optimal selection decisionsKnowingyourgoals–balancingdecisionsonquality, ●

timelines and trial costsTheimpactofsiteselectiononselectionprocesses– ●

localexpertiseandavailabilityofresourcesDevelopingstudymetricsandkeydeliverablesofatrial ●

10:15 The process of selectionUnderstandingcandidatespartnerscapabilities ●

and strengthsRequestsforinformationandrequestsforproposals ●

Due diligence and analysis of proposals ●

MatchingtrialstoappropriateCROs ●

11:00 Refreshments

11:30 Contract negotiation and agreementMatching contracts to desired trial outcomes ●

Choosingafixed,fixedunitpricedorvariablecontract ●

Protecting your trial against cost and time overruns ●

12:15 Project monitoring and evaluationPlanningtheprojectmanagementfunctionstoensure ●

adequateoversightfunctionsDeveloping performance metrics for measuring conduct ●

and outcomes of the trialEarnedvalueanalysis ●

13:00 Close of workshop

About your workshop leaders:Roger Joby B.Sc. MAPMistheManagingDirectorof1to1to1.Rogerhasbeeninvolvedinthepharmaceuticalindustryforover30yearsworkingforbothCROsandpharmaceuticalcompaniesandnowasanindependentconsultant.Roger’sexperienceincludesprojectmanagement,proposalgeneration,sub-contractorcontactsandprojectfinance.

1to1to1ispartofR.&N.R.Consultingspecialisinginprojectmanagementconsultancyinclinicalresearch.ThecompanywasformedinMarch2000andhasarangeofclientsthatincludelargeandmediumsizedpharmaceuticalcompanies,bio-techsandCROs

Who should attend?The audience will be made up of Vice Presidents, Directors and Managers within pharmaceutical and biotech companies from the following areas:

• Outsourcing

• ClinicalOperations

• Procurement

• ExternalAlliances

• ClinicalTrials

• ClinicalResearch

• R&D

• ProjectManagement

• Contracts

• Legal

• Counsel

About the ConferenceVIBpharma is proud to announce the launch of our second annualClinicalTrialsinEmergingMarketsconferencetakingplaceinPragueon1-2March2010.

In the current economic climate reducing costs and increasing efficiency during the clinical trial process is crucial to sustaining the long term development of new treatments.Thereexistschallenges,insettingupandrunningaclinicaltrialthatmustbeovercome.Akeyfactor in determining the effectiveness of your trial is recruitingtherighttypesofpatientsattherighttime.Itisacomplexandintricatearea,requiringknowledgeofhumanbehaviour,marketingandmanagementexpertise,togetherwithscientificknowledge.

Asmorepharmaandbiotechcompanieslooktoemergingregions to conduct their studies the need for information, expertise,guidanceandadviceonmanagingthepitfallsofoperating in new and unfamiliar countries becomes greater thanever.EmergingregionssuchasEasternEuropeandAsia,wherelargepatientpopulationsareavailablepose,opportunitiesbutalsorisks.Keychallengesencounteredby sponsors include:

Obtaining regulatory approval in trial sites and ●

workingwithnationalregulatorsinaneverchangingbureaucratic landscape

Import licences and overcoming supply chain issues ●

Infrastructure and communications challenges in ●

developing countries

Choosing trials partners and outsourcing to local ●

or global CROs - ensuring that the partnership iseffectively managed is paramount

Recruitingadequatelytrainedclinicalinvestigators ●

VIBpharma’sClinicalTrialsinEmergingMarketsconferencewill bring together pharma and biotech companies to share solutions to strategic and operational challenges insettingupandconductingstudiesinnewterritories.Attendeeswillhearfromexperiencedprofessionalswhowillsharetheirknowledgeonmakingthemostoftheopportunities and benefits of conducting trials in emerging markets.Attendthispractical,insightfulandsolutionledevent to generate new cost and time saving ideas

Media Partners:Pharmaceutical Technology is used daily as a means of creating partnerships and as a point of

referencebyprofessionalswithinthepharmaceuticalindustry.This comprehensive resource supplies the latest news releases, detailedinformationonindustryprojects,whitepapers,eventinformationandathoroughbreakdownofproductsandservices.www.pharmaceutical-technology.com

Biocompareisthemostcomprehensive,in-depth,andobjectivewebsiteforlifescienceproductinformation.ThousandsofscientistsuseBiocomparedailytoquicklyfindtherightproductfortheirexperimentsratherthanlookingthroughmultipleprintcatalogs.Visitwww.biocompare.com to find the products you need, stay informed of new technologies, read product reviews, watch product videos, andkeepup-to-dateonlifesciencenews.

GlobalData'sReportStorefeatures thousands of high

qualityresearchreportsacrossabroadrangeofindustries.Thereportsdrawonin-depthprimaryandsecondaryresearch,databasesofproprietaryinhousedataandhighqualityanalysisfromourexpertteams.Dataandanalysisatthecompany, country and industry level includes competitors, valuations,trends,forecastsandanalytics. www.global-market-research-data.com

Silver sponsor:DOKUMEDS CRO EasternEuropebasedFullServiceCROoperatingsince

1995inLatvia,Lithuania,Estonia,RussiaandUkraine.PhaseII-IVclinicalR&DservicesincludingProjectManagement,RegulatoryServices,ContractandFinanceManagement,DataManagementandMedicalConsultancy.MemberofCROsalliance(Acrossalliance)operatinginEast-CentralandSouthEurope;ISOcertifiedinInternationalProjectManagement.www.dokumeds.lv

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