e-clinical Trials vibpharma register now: tel: +44 (0) Fax: +44 (0)

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1 vibpharma e-clinical Trials tuesday 18 and Wednesday 19 May 2010, Munich, Germany Maximising clinical trial supply efficiency by utilising advanced e-tools and systems Choose from a selection of roundtable topics to discuss the latest issues with your peers Main highlights include: 16 leading pharma and biotech companies represented on the programme, delivering case study driven presentations A practical peer-to-peer learning environment to enable you to find solutions to key issues Streamed presentations to cater to your personal needs in Clinical Operations or Data Management Industry-led round table discussions on business critical issues to ensure that you get practical answers to your questions KeynOte SPeaKerS: Dr Johann Pröve, Global Head Data Management, Bayer healthcare ag Massimo raineri, Head of Systems Development, Biometry, actelion Detlef nehrdich, Director Statistics, Data Management & EDC Project Office Europe, Global Statistics & Data Management, abbott hans Martens, Associate Quality Consultant, eli lilly Dr Olav Flaten, Medical Director, GlaxOSMithKline ingela larsson, Head Clinical Trials, JanSSen-CilaG Silvana Cappi, Executive Director of Biometrics, FerrinG PharMaCeUtiCalS Mats Sundgren, Principal Scientist, Clinical Information Strategy, Global Clinical Development, astrazeneca top COMPanieS represented include: 1. astellas 2. F.hoffmann la roche 3. Bayer 4. CDiSC 5. GlaxoSmithKline 6. novo nordisk 7. hl7 8. Ferring Pharmaceuticals 9. Boehringer ingelheim Silver sponsors: register now: tel: +44 (0) Fax: +44 (0) the 2 March 2010 and save 490 register online now at:

2 Programme Day One Tuesday 18 May :30 Registration and refreshments 09:00 Opening remarks from the Chair Dr Olav Flaten, Medical Director, GlaxoSmithKline A look into the future of the industry and the role of e-clinical trials to maximise profitability of the organisation 09:10 Keynote: Moving forward with fully electronic systems to maximise the efficiency of clinical trial performance Dealing with the increasing amount of data and outlining the necessity of standardisation and full interoperability of e-clinical trial systems Evaluating the current legislative framework and guidelines to ensure regulatory compliance Outlining the development of EHRs (Electronic Health Records) as a reality and what that means for the pharmaceutical and healthcare industry Exploring trends an outlook into the future and new technologies already materialising on the horizon Dr Olav Flaten, Medical Director, GlaxoSmithKline 09:50 An e-clinical vision for the future gaining full business benefits Shifting focus from data integration to defining interoperability that simplifies user workflow Identifying how e-tools improve performance measurement and proof of ROI Convergence of technologies and consolidation of data to improve clinical trial performances Platform considerations to deliver this vision Bill Byrom, Senior Director, Product Strategy, Perceptive Informatics 10:30 Optimising CRO cooperation by putting efficient outsourcing strategies in place examples from data management Choosing the right approach for outsourcing strategies by deciding what and 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 and how to overcome this hurdle Implementing metrics reporting and alerting mechanisms to stay in control of your clinical trials performance Dr Johann Pröve, Global Head Data Management, Bayer HealthCare AG 11:10 Morning refreshments and networking The way forward analysing the current and future developments of EHRs (Electronic Health Records) 11:40 Exploring the future of the pharmaceutical and healthcare industry the benefits of EHRs becoming a reality Outlining the current status of EHRs and how they link patient care, clinical research and public health Identifying the benefits and opportunities of EHRs for the pharmaceutical industry and how they will change the market landscape Dealing with the challenges of EHRs data integration into electronic data management systems Analysing the safety and ethical issues arising from EHRs Uncovering the regulatory framework and HL7 standards for EHRs Mats Sundgren, Principal Scientist, Clinical Information Strategy, Global Clinical Development, AstraZeneca 12:20 Panel session: maximising the market share of a biosimilar product by utilising efficient marketing and pricing strategies 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-clinical systems Clarifying if EDC will become redundant when EHRs become an established reality Speculating who will cover the costs to put EHRs systems in place in Europe Determining USA s ambition of having EHRs for all citizens in place by 2014 Mats Sundgren, Principal Scientist, Clinical Information Strategy, Global Clinical Development, AstraZeneca Dr Olav Flaten, Medical Director, GlaxoSmithKline Dr Uwe Barlage, Project Leader EDC, Bayer Vital AG 13:00 Lunch and networking Interactive Stream A 14: Interactive Stream B 14: Maximising clinical trials performance with efficient utilisation of e-tools 14:00 Case study: A pioneer s point of view on utilising digital pens to maximise the efficiency of clinical trials Improving quality of data and timelines for clinical trials by implementing digital pens in clinical trial conduction Outlining the benefits of this technology and device and how it improves clinical trial outcomes Establishing user friendliness and looking at how it can be improved Ensuring the captured results are fully 21CFR Part 11 compliant to guarantee legislative approval Massimo Raineri, Head of Systems Development Biometry, Actelion 14:40 Case study: Maximising the efficiency of statistical analysis and output generations by using ecrfs Outlining how electronic CRFs help to reduce time on data query management and how this benefits your clinical trial timelines Speeding up data collection by implementing an ecrf accustomed to your study needs Optimising clean data collection by sophisticated automatic data checking Exploring how ecrfs simplify remote monitoring processes of your clinical trial performance Detective Sergeant Dannie Parkes, WEST MIDLANDS POLICE, UK 15:30 Case study: Overcoming the challenges of conducting clinical trials on a global basis by efficient electronic data management systems Assessing cultural, communicational and time zone differences of global study teams and how to overcome these challenges by implementing online share points Implementing a step-by-step approach to global clinical trial management to maximise study efficiency Exploring how to manage different data sources and how to integrate data from other sites into your in-house platform Analysing the benefits of conducting clinical trials on a global basis such as better access to patient populations, cost-effectiveness and opening your portfolio Jonathan Davies, Director Clinical Trials, Medical Affairs Europe, Astellas Pharma Europe Exploring the technological benefits and pitfalls of e-clinical trials data management systems 14:00 Being ahead of the game utilising EDC systems to maximise your clinical trial performance metrics Exploring the pitfalls and benefits of today s open and closed EDC systems and how to optimise existing systems Minimising extensive duplication in data input through efficient use of ecrfs in EDC Outlining how to utilise EDC to measure performance metrics to detect improvement necessity Understanding the potential of EDC as a detector of risks Pieter Voermans, Deputy Site Head, Clinical Data Management, F.Hoffmann La Roche

3 Programme Day One Tuesday 18 May 2010 Interactive Stream B 14: :40 EHR, standardisation and interface with EDC - a wish list from the perspective of drug development Forecasting the connection benefits and pitfalls of EHRs with EDC in the near future Setting up suitable EDC systems that will handle the immense data flow from EHRs Identifying pitfalls and benefits from reusing EHRs in drug development Overcoming issues in EHR interoperability including legal, technical, organisational, financial and political will Predicting future trends of standardised EHR systems in place Dr Uwe Barlage, Project Leader EDC, Bayer Vital AG 15:20 An auditors point of view: epro audits & investigations to maximise system efficiency Outlining applicable regulations and expectations, including ICH-GCP and 21 CFR Part 11 to ensure compliance Introducing the FDA guidance on epro and computerised systems Analysing important aspects of computerised systems: security, business continuity, infrastructure to maximise efficiency of systems Identifying the most efficient models for computer system validation Identifying fundamental elements of data quality to achieve optimal results Understanding erisks and successful strategies to overcome them Hans Martens, Associate Quality Consultant, Eli Lilly Interactive Stream B 16: Exploring the technological benefits and pitfalls of e-clinical trials data management systems 16:30 Efficient data cleaning strategies Sharing responsibilities: who cleans what? Understanding when it s best to clean data to maximise process efficiency The importance of appropriate process definition and compliance tracking Defining quality of data how much is enough? Detlef Nehrdich, Director Statistics, Data Management & EDC Project Office Europe, Global Statistics & Data Management, Abbott 17:10 Uncovering the most efficient data warehouse architecture for clinical data warehousing for long-term storage and accessibility solutions Choosing a data warehouse architecture top-down versus bottom-up design methodologies Outlining methods on how to achieve long-term data accessibility Identifying methods on how data warehouses support the reporting and performance review processes to measure actual performance versus goals of clinical trials Reducing maintenance costs while maximising performance and accessibility Exploring the new JANUS clinical trial data repository based on SDTM and it s impact on data warehousing and clinical trials Peter Bossier, Managing Director, e-novex 16:00 Afternoon refreshments and networking Interactive Stream A 16: Practical case studies of efficient utilisation of e-tools in clinical trials 16:30 Discussing how RDC can optimise relationships with Data Monitoring Committees (DMC) Review the increasing demands of DMCs within Clinical studies. How does RDC and e-source offer solutions? Communication strategies Case study - demonstrating the success of weekly transfers of data to DMC Mireille Zerola, Data Management Specialist, Boehringer Ingelheim 17:10 An investigators point of view: exploring primary care challenges undertaking e-clinical trials Outlining the user friendliness of e-clinical trial tools and showing ways how to improve the role of investigators Struggling with different software and technologies for each trial and showing how to improve systems Overcoming data transfer challenges by utilising e-tools and sharing points Ensuring GCP compliance to achieve successful study outcomes Forecasting the benefits of EHR in primary care research and for conducting clinical trials as investigators Dirk Langeneckert, Head Data Management Coordination, Merck 17:50 Closing remarks from the Chair and end of Day 1 REGISTER ONLINE NOW! pharma/e-clinical/index.html the 2 March 2010 and save 490

4 Programme Day Two Wednesday 19 May :30 Registration and refreshments 09:00 Opening remarks from the Chair Bengt Fältström, Senior Clinical Data Manager, AstraZeneca 09:10 Roundtable morning 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 an aspect of e-clinical Trials. Roundtable 1 Identifying efficient outsourcing strategies and analysing decision making processes to be considered Pieter Voermans, Deputy Site Head, Clinical Data Management, F.Hoffmann La Roche Roundtable 2 Exploring the benefits and challenges of conducting global e-clinical trials by working with virtual study teams Bengt Fältström, Senior Clinical Data Manager, AstraZeneca Roundtable 3 Implementing efficient EDC related change management strategies to maximise the efficiency of EDC utilisation and communication strategies Detlef Nehrdich, Director Statistics, Data Management & EDC Project Office Europe, Global Statistics & Data Management, Abbott Roundtable 4 Maximising interoperability of electronic systems to optimise workflows, reduce ambiguity and enhance knowledge transfer by implementing and complying to HL7 standards Dr. Georg Heidenreich, Board Member, HL7 Germany Roundtable 5 Identifying methods how data warehouses support the reporting and performance review processes to measure actual performance versus goals of clinical trials Mikkel Traun, Lead Architect Clinical Data Warehouse Systems, Novo Nordisk Roundtable 6 Overcoming hurdles in the phase where all the EDC work can collapse Electronic Data Transfer Massimo Raineri, Head of Systems Development, Biometry, Actelion 12:30 Lunch and networking Evaluating the current legislative environment and its impacts on the e-clinical trials landscape 13:30 A roadmap for integration and interoperability exploring the latest developments of CDISC standards Outlining the latest developments in CDISC (Clinical Data Interchange Standards Consortium) Increasing the efficiency of data management with CDISC and CDASH (Clinical Data Acquisition Standards Harmonization) Discussing standardisation and interoperability through CDISC and CDASH The impact of the FDA acceptance of SDTM V Uncovering CDISC SHARE a global e-library enabling prices and standardised data element definitions to improve biomedical research and linking it with the healthcare industry Veronica A. Martin, Data Stewardship Operations, GlaxoSmithKline 14:10 Case study: exploring CDISC standards implementation as a route to more cost-effective data management in e-clinical trials Outlining cost savings and increase in efficiency to build a business case for CDISC standards implementation Identifying internal partners to create a consensus on standardisation and develop an action plan for implementation Maximising the financial and strategic figures by complying to CDISC standards and how this improves information sharing and data integration Conforming to standards to harmonise data prior to submission and reducing the time to market Silvana Cappi, Executive Director of Biometrics, Ferring Pharmaceuticals 14:50 Case study: maximising clinical metadata driven data flow and reporting processes an implementation case at Novo Nordisk Outlining the central definition and control of standards a way to ensure data integration and standardisation Optimising clinical trial metadata by front loading the process and actively working with trial requirements Maximising the use of clinical metadata in the data review and reporting processes using SAS DD Utilising clinical data and metadata for more than a trial Google your metadata Kirsten Walther Langendorf, Clinical Standards Specialist with focus on CDISC Standards, Novo Nordisk 15:30 Afternoon refreshments and networking 16:00 Panel session: Leveraging CDISC standards to ensure effective data management for e-clinical trials Discussing standardisation and interoperability through CDISC and CDASH Identifying CDISC standards and guidelines for customising systems to ensure maximum efficiency Facilitating a more efficient review process and ability to locate and query data more easily through automated processes and data standards Benefitting from e-submissions by saving crucial time and money Outlining how to save costs and increase efficiency by complying to CDISC standards Veronica A. Martin, Data Stewardship Operations, GlaxoSmithKline Silvana Cappi, Executive Director of Biometrics, Ferring Pharmaceuticals Kirsten Walther Langendorf, Clinical Standards Specialist with focus on CDISC Standards, Novo Nordisk Bengt Fältström, Senior Clinical Data Manager, AstraZeneca 16:40 Creating the best and most widely used standards in healthcare outlining the latest developments of HL7 standards and their impact on e-clinical trials Specifying HL7 standards, guidelines and methodologies to facilitate interfaces between e-clinical trials systems Ensuring seamless integration from one system to another to maximise clinical trial performances Improving communication and interoperability between different e-clinical trials systems with HL7 Exploring the impact and new trends such as HL7 wikis Aligning standards for use of EHR data for research, quality, public health and safety the concept of CDISC SHARE Dr. Georg Heidenreich, Board Member, HL7 Germany and Dr Marta Jaremek, Working Group Clinical Genomics, HL7 Germany 17:20 Closing remarks from the Chair 17:25 Champagne prize draw 17:30 Close of conference

5 Who should attend The audience will be made up of senior representatives from biotech and pharmaceutical companies working within the following areas: Clinical Data Management Clinical Operations Clinical Development Monitoring Systems Clinical Research EDC Clinical Information Management Medical Information Systems CDISC CTMS Pharmacovigilance Clinical QA Regulatory Affairs Clinical Project Management Clinical Auditors Heads of Quality Control/Assurance/GCP Compliance Clinical Statisticians Programmers Investigators about the conference The majority of pharma and biotech companies today conduct their clinical trials using fully integrated, webenabled technological systems. The profit from benefits such as time and cost savings as well as higher quality of data in real-time and increased process efficiency. Even though e-clinical trials are not a new phenomenon in the industry, the boundaries and possibilities are becoming less clear as the technologies, processes and standards continue to evolve. Being able to keep at the forefront of this constantly changing environment is essential to speeding your products to market. Back by popular demand, VIBpharma is proud to announce the 10th annual e-clinical trials conference on tuesday 18 and Wednesday 19 May 2010 in Munich, Germany. Through a series of presentation, case studies and interactive discussions, attendees will gain practical insight into key issues such as how the whole e-clinical mix is improving the various functional areas of clinical trials and on how pharma and biotech companies can maximise their cost and time savings. From improving your data management capabilities, standardisation, data integration and strategies to maximise investigator access to the added value of EHR methodologies, this conference will provide strategies for creating a fully integrated, web-enabled e-clinical trial system. Silver Sponsors Perceptive informatics, the industry s leading e-clinical solutions provider, combines clinical knowledge and experience with leading technology to decrease time to market, risk and cost associated with clinical trials. Our portfolio includes medical imaging, IVRS, EDC, CTMS, epro and integration services, as well as portals, tracking tools and investigator database solutions. exhibitors Co-Sponsor Media Partners World Pharmaceutical Frontiers Supporting association if you want to be a part of this successful event, we have a number of sponsorship opportunities available. Contact rizwan Qayum to discuss your specific requirements on rizwanqayum@arena-international.com or call

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