e-Clinical Trials

Programme Day One Tuesday 18 May 201008:30 Registration and refreshments09:00 Opening remarks from the ChairDr Olav Flaten, Medical Director, GlaxoSmithKlineA look into the future of the industry and the roleof e-clinical trials to maximise profitability of theorganisation09:10 Keynote: Moving forward with fully electronic systems tomaximise the efficiency of clinical trial performance●●●●●●●●Dealing with the increasing amount of data and outlining the necessity ofstandardisation and full interoperability of e-clinical trial systemsEvaluating the current legislative framework and guidelines to ensureregulatory complianceOutlining the development of EHRs (Electronic Health Records) as a realityand what that means for the pharmaceutical and healthcare industryExploring trends – an outlook into the future and new technologies alreadymaterialising on the horizonDr Olav Flaten, Medical Director, GlaxoSmithKline09:50 An e-Clinical vision for the future –gaining full business benefits●● Shifting focus from data integration to defining interoperability thatsimplifies user workflow●● Identifying how e-tools improve performance measurement and proof of ROI●● Convergence of technologies and consolidation of data to improve clinicaltrial performances●● Platform considerations to deliver this visionBill Byrom, Senior Director, Product Strategy, Perceptive Informatics10:30 Optimising CRO cooperation by putting efficient outsourcingstrategies in place – examples from data management●● Choosing the right approach for outsourcing strategies by deciding whatand how to outsource while balancing costs, time and quality of results●● Analysing multiple outsourcing strategies●● Outlining the challenges of different data formats from each provider andhow to overcome this hurdle●● Implementing metrics reporting and alerting mechanisms to stay in controlof your clinical trials performanceDr Johann Pröve, Global Head Data Management, Bayer HealthCare AG11:10 Morning refreshments and networkingThe way forward – analysing the current and futuredevelopments of EHRs (Electronic Health Records)11:40 Exploring the future of the pharmaceutical and healthcareindustry – the benefits of EHRs becoming a reality●●●●●●●●●●Outlining the current status of EHRs and how they link patient care, clinicalresearch and public healthIdentifying the benefits and opportunities of EHRs for the pharmaceuticalindustry and how they will change the market landscapeDealing with the challenges of EHRs data integration into electronic datamanagement systemsAnalysing the safety and ethical issues arising from EHRsUncovering the regulatory framework and HL7 standards for EHRsMats Sundgren, Principal Scientist, Clinical Information Strategy, GlobalClinical Development, AstraZeneca12:20 Panel session: maximising the market share of a biosimilarproduct by utilising efficient marketing and pricingstrategies to secure a market share●● Establishing how the e-clinical landscape will look with EHRs in place●● Analysing the interoperability challenges of EHRs and existing e-clinicalsystems●● Clarifying if EDC will become redundant when EHRs become anestablished reality●● Speculating who will cover the costs to put EHRs systems in place inEurope●● Determining USA’s ambition of having EHRs for all citizens in place by 2014Mats Sundgren, Principal Scientist, Clinical Information Strategy,Global Clinical Development, AstraZenecaDr Olav Flaten, Medical Director, GlaxoSmithKlineDr Uwe Barlage, Project Leader EDC, Bayer Vital AG13:00 Lunch and networkingInteractive Stream A 14:00 – 16.00Interactive Stream B 14:00 – 16.00Maximising clinical trials performancewith efficient utilisation of e-tools14:00 Case study: A pioneer’s point of view onutilising digital pens to maximise theefficiency of clinical trials●● Improving quality of data and timelines for clinical trials byimplementing digital pens in clinical trial conduction●● Outlining the benefits of this technology and device andhow it improves clinical trial outcomes●● Establishing user friendliness and looking at how it can beimproved●● Ensuring the captured results are fully 21CFR Part 11compliant to guarantee legislative approvalMassimo Raineri, Head of Systems Development –Biometry, Actelion14:40 Case study: Maximising the efficiency ofstatistical analysis and output generationsby using eCRFs●● Outlining how electronic CRFs help to reduce time on dataquery management and how this benefits your clinical trialtimelines●● Speeding up data collection by implementing an eCRFaccustomed to your study needs●● Optimising clean data collection by sophisticatedautomatic data checking●● Exploring how eCRFs simplify remote monitoring processesof your clinical trial performanceDetective Sergeant Dannie Parkes,WEST MIDLANDS POLICE, UK15:30 Case study: Overcoming the challenges ofconducting clinical trials on a global basisby efficient electronic data managementsystems●● Assessing cultural, communicational and time zonedifferences of global study teams and how to overcomethese challenges by implementing online share points●● Implementing a step-by-step approach to global clinicaltrial management to maximise study efficiency●● Exploring how to manage different data sources andhow to integrate data from other sites into your in-houseplatform●● Analysing the benefits of conducting clinical trials on aglobal basis such as better access to patient populations,cost-effectiveness and opening your portfolioJonathan Davies, Director Clinical Trials, Medical AffairsEurope, Astellas Pharma EuropeExploring the technological benefitsand pitfalls of e-clinical trials datamanagement systems14:00 Being ahead of the game – utilising EDCsystems to maximise your clinical trialperformance metrics●● Exploring the pitfalls and benefits of today’s open andclosed EDC systems and how to optimise existing systems●● Minimising extensive duplication in data input throughefficient use of eCRFs in EDC●● Outlining how to utilise EDC to measure performancemetrics to detect improvement necessity●● Understanding the potential of EDC as a detector of risksPieter Voermans, Deputy Site Head, Clinical DataManagement, F.Hoffmann – La Roche

Who should attendThe audience will be made up of seniorrepresentatives from biotech and pharmaceuticalcompanies working within the following areas:●●●●●●●●●●●●●●●●●●●●Clinical Data ManagementClinical OperationsClinical DevelopmentMonitoring SystemsClinical ResearchEDCClinical Information ManagementMedical Information SystemsCDISCCTMSPharmacovigilanceClinical QARegulatory AffairsClinical Project ManagementClinical AuditorsHeads of Quality Control/Assurance/GCPComplianceClinical StatisticiansProgrammersInvestigatorsabout the conferenceThe majority of pharma and biotech companies todayconduct their clinical trials using fully integrated, webenabledtechnological systems. The profit from benefitssuch as time and cost savings as well as higher qualityof data in real-time and increased process efficiency.Even though e-clinical trials are not a new phenomenonin the industry, the boundaries and possibilities arebecoming less clear as the technologies, processesand standards continue to evolve. Being able to keepat the forefront of this constantly changing environmentis essential to speeding your products to market.Back by popular demand, VIBpharma is proud toannounce the 10th annual e-Clinical trials conferenceon tuesday 18 and Wednesday 19 May 2010 in Munich,Germany. Through a series of presentation, casestudies and interactive discussions, attendees willgain practical insight into key issues such as how thewhole e-clinical mix is improving the various functionalareas of clinical trials and on how pharma and biotechcompanies can maximise their cost and time savings.From improving your data management capabilities,standardisation, data integration and strategies tomaximise investigator access to the added value of EHRmethodologies, this conference will provide strategiesfor creating a fully integrated, web-enabled e-clinicaltrial system.Silver SponsorsPerceptive informatics®, the industry’sleading e-Clinical solutions provider,combines clinical knowledge andexperience with leading technology to decrease time to market,risk and cost associated with clinical trials. Our portfolio includesmedical imaging, IVRS, EDC, CTMS, ePRO and integration services,as well as portals, tracking tools and investigator database solutions.www.perceptive.comexhibitorsCo-SponsorMedia PartnersWorld Pharmaceutical Frontierswww.e-novex.comwww.nnit.comwww.worldpharmaceuticals.netSupporting associationif you want to be a part of this successfulevent, we have a number of sponsorshipopportunities available.Contact rizwan Qayum to discuss your specific requirements onrizwanqayum@arena-international.com or call +4420 7753 4259

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