Cdsm 2011 bro (final)


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Event brochure for the upcoming Clinical Data Standardisation and Managment event in London, June.
The event will feature best practice case studies from CDISC

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Cdsm 2011 bro (final)

  1. 1. Register and pay before 29th April 2011 to save up to £300 Presents the 2nd Annual *terms apply Clinical Data Standardisation and Management Venue: America Square Conference Centre, London, UK Benchmark your Main conference: 7th – 8th June 2011 with 16 leading experts Pre-Conference: 6th June 2011 from the realm of clinical data management: Developing optimum strategies for improving Phillippe Verplancke, CDISC E3C clinical data management through CDISC Member standardisation, best-practice outsourcing, data Peter Van Reusel, CDISC E3C Member and Business Unit warehousing and legacy data transformation Director of CRO Services, Business & Decision Our panel of experts will help you to: Herbert Noack, Vice Chair, w Understand the latest CDISC initiatives and how their CDISC E3C Member & Project applications can benefit you in the clinical data world: three Statistician – Medical Affairs, CDISC E3C members give their insights Boehringer Ingelheim Andrew Miller, Director of w Discover and apply the best-practice approach to outsourcing Clinical Data Standards, clinical data to CROs: Bristol-Myers Squibb and Nycomed AstraZeneca present their evidence Sue Dubman, Senior Director, w Optimise performance through end-to-end CDISC alignment in Standards and Architecture, your business: AstraZeneca, Genzyme and Antisoma share their Genzyme experience Kjell Pennert, Head of Research Data Management and Statistics w Fast-track regulatory submissions using CDISC standards: LEO Unit, The Royal Marsden NHS Pharma show you how Foundation Trust w Setup and maintain metadata repositories to better govern your Albert Chau, Head of Biometrics, clinical data: CDISC, Roche and Eli Lilly give you their examples Antisoma w Plan your company’s journey through data standardisation with Chris Price, Senior Technical illustrative case studies from Roche and Merck amongst others Programmer, Roche Berthold Traub, Associate Director, Nycomed GmbH Advisory Board Peter Van Reusel, CDISC E3C Member Albert Chau, Head of Biometrics, Paul Vervuren, Head Scientific and Business Unit Director of CRO Antisoma Programming Women’s Health & Services, Business & Decision Endocrine, MSD Francis Kendall, Head of Programming, Andrew Miller, Director of Clinical Data Roche Francis Kendall, Head of Standards, AstraZeneca Programming, Roche Yiannis Karageorgos, Senior Pre-conference Workshop Day: Top highlights you can’t afford to Protocol Data Manager, Bristol- 6th June 2011 miss: Myers Squibb Take the time to discuss and share 4 Three members of CDISC E3C discuss Bruce Basson, Statistician, Eli Lilly ideas with leading experts in your the current state of play with regards Zoe Williams, Clinical Biometrics field in two interactive workshop to cross-industry data standardisation Manager, LEO Pharma mini-courses: Julie James, HL7 Board Member 4 Four interactive discussions with A) CDISC Implementation experts in the data management field & Partner, Bluewave Informatics Workshop Hugh Glover, HL7 Board Member 4 Gain an in-depth understanding of the & Partner, Bluewave Informatics B) Integration and Interoperability: issues involved in data warehousing, Getting To Grips With HL7 legacy data transformation and end to end, CDISC alignment “Good to meet the main players and have made contacts that I would not have made otherwise.” Medimmune Tel: +44 (0)20 7368 9300 Email: Web:
  2. 2. Conference Day One: 7th June 201108.30 Coffee and Registration w Focusing on oversight of SAS programming as a critical process feature w Exploring how to implement in-house quality control and quality09.00 Chair’s Opening Remarks and Pharma IQ Welcome standards for maximal process surveillance Albert Chau, Head of Biometrics, Antisoma w Understanding the crucial nature of “review” – oversight vs.09.10 Ice Breaking Session working together A great opportunity to meet your peers who you will be interacting Berthold Traub, Associate Director, Nycomed GmbH with and learning from over the next two days. Take the chance to 14:40 Thinking Outside the Box - Discussion Session say what you’re looking to gain out of the event and what you’re looking This is where we throw the format out the window and open the forward to. At the end of this session, delegates will be encouraged to floor to you. In this 40 minute session, our panel will choose anonymously submit questions and topics of conversation into a questions at random from the submissions box. Discussion and suggestions box for the Thinking Out of the Box discussion session. debate will ensue – thinking outside of the box is encouraged. KEYNOTE SESSION: CDISC UPDATE 2011 15:10 Networking Coffee Break09.20 The Future Of CDISC Standards Development Driven By The SHARE Project PHARMA FOCUS: HL7 and Standardisation w What CDISC SHARE will bring to the clinical data management fold 15:40 Integration And Interoperability: HL7 In The Realm Of w Showcasing the status and time plan of the project thus far Pharma/Bio Focus w Learning how to fill the metadata repository with therapeutic area w Introducing HL7: defining healthcare information in a standards semantically robust way w Understanding the CDISC governance process w The use of these standards by regulators: clinical trials reporting w Using a CDISC-based metadata repository to drive each activity and results (CTRR) and identification of medicines (IDMP) and ICSR within the clinical data management chain w Capitalising on the investment in conforming to these new w Starting today: the re-use of metadata from define.xml for CRF design standards allows companies to learn to use the principles of HL7 Phillippe Verplancke, CDISC E3C Member and semantic interoperability for a much wider set of applications than just those “required” by the regulators Implementing CDISC Standards In Large And Small Pharma Companies w Leveraging the opportunity of interoperability with EHR10.00 Implementation Of CDISC Standards In A Small Oncology- information - for EDC and for wider research Focused Company With Data Management Outsourced w Maximising the return on the existing portfolio of medicines w How a semi-virtual biotechnology company has implemented requires maximum information, basing that information on HL7 CDISC standards over the past few years will make it easier to get the information out without excessive w Challenges and benefits on the implementation of CDISC standards analysis costs in a small company Julie James, HL7 Board Member & Partner, Bluewave Informatics w Processes that have been put in place to ensure a consistent Hugh Glover, HL7 Board Member & Partner, Bluewave Informatics approach in an outsourcing model w Considerations and challenges in implementing CDISC standards in The Best-Practice Case In The Offshoring Of Statistical Programming a cancer trial setting 16:20 CASE STUDY: Important Points To Consider When w Considerations in mapping legacy data into a CDISC-compliant structure Offshoring Statistical Programming: Experience Based w The benefits of CDISC standards in promoting and improving data On Offshoring At Pfizer, Novartis And Roche quality and efficiency in data review w Assessing the position that offshoring is essential to gain access to Albert Chau, Head of Biometrics, Antisoma a wider talent pool w Appreciating the pros and cons of offshoring: potential cost savings10.40 Networking Coffee Break vs. oversight, training etc.11.10 The Astrazeneca Journey To CDISC Implementation w Exploring the best offshoring model for your business – captive, w Overview of the Astrazeneca standards governance model semi captive and full CRO models w Tactical versus strategic implementation of CDISC standards w Understanding that an offshored workload has to be truly w CDISC standards – complimentary or a replacement for existing transactional to obviate large hidden costs standards? w Appreciating that offshored tasks should best be low to medium w Governance and version control of CDISC standards within AstraZeneca complexity in nature to avoid confusion w Lessons learnt w Ensuring that offshore sponsors allow for a high turnover rate in w Future plans for CDISC implementation India and understand the consequent impacts on training plans and Andrew Miller, Director of Clinical Data Standards, AstraZeneca what work can be offshored w Keeping an eye on the economic variables: inflation, turnover and Outsourcing: Keeping Things Out Of Your Control Under Control productivity11.50 CASE STUDY: On the Path To Optimising The Sponsor w Considering the case for automation of transactional activities CRO Relationship rather than offshoring w Assessing the factors that influence pharmaceutical research Francis Kendall, Head of Programming, Roche sponsors in their selection and retention of contract research vendors and partners Pharma Focus: Data Managers in the Spotlight w Exploring the full project to the full function/task outsourcing continuum 17.00 On The Evolving Role Of The Data Manager In The w Understanding the type of sponsor project manager would serve Pharma/Biotech/Healthcare Industries each outsourcing “style” best? w Showcasing how the introduction of technology has changed the w Data flow vs. data quality reports: examining score-cards, landscape of data management in the last 10 years performance evaluators and due diligence w Focusing on how standardisation of formats and process across w Specialised procedures, central readers/adjudication committees, the industry will prompt even more pronounced changes in the central laboratory and whether it is project or functional outsourcing? clinical data manager’s role w Appreciating the crucial need for standardising template contract w Examining how the introduction and integration of e-sources has agreements and benchmarking partners vs. in-sourced activities and will further promote a shift from processes centred on Yiannis Karageorgos, Senior Protocol Data Manager, Bristol-Myers Squibb cleaning data to a focus on managing data flow w Exploring the move towards the provision of real-time data to the12:30 Lunch different stakeholders of a clinical trial14:00 CASE STUDY: Nycomed’s Experience On How To Run An w Understanding how the clinical data manager’s role will be defined Extreme Outsourcing Model in an automated e-future w Introducing the clinical trial team setup and framework at Nycomed Kjell Pennert, Head of Research Data Management and Statistics w Examining how to construct and implement a data integration plan Unit, The Royal Marsden NHS Foundation Trust as the basis of all CRO-led standardisation 17.40 Closing Remarks From The Chair And End Of Day One w Agreeing on SOPs with respect to quality for a well defined processTel: +44 (0)20 7368 9300 Fax: +44 (0)20 7368 9301 Email:
  3. 3. Conference Day Two: 8th June 201108.30 Coffee And Registration C Towards A Unified Approach For Standardising Legacy Data09.00 Chair’s Opening Remarks and Pharma IQ Welcome Moderator: Peter Van Reusel, CDISC E3C Member and Business Unit Director of CRO Services, Business & Decision Andrew Miller, Director of Clinical Data Standards, AstraZeneca D The Role Of The Data Manager: A Dying Or Evolving Breed CDISC UPDATE Kjell Pennert, Head of Research Data Management and Statistics09.10 CDISC-ADaM And The Concept Of “One Proc-Step Away” Unit, The Royal Marsden NHS Foundation Trust w Understanding that different philosophies with respect to analysis 12.40 Lunch datasets still exist w Exploring what is optimal for the statistical and clinical reviewer at Examining CDISC And Regulatory Compliance the FDA 14.00 Showcasing Metadata Repositories As A Focus w Examining the CDISC-ADaM standard: going from cookbook to Of Pharma/Biotech Companies therapeutic area needs w Comparison of different approaches to achieving data in CDISC w Unraveling “one proc-step away” as defined in the statistical format for submission analysis plan w Feedback on experience of submitting test data to the FDA w Assessing derivations and traceability in the CDISC-ADaM structure w Considerations for the documentation that accompanies the data w How to be prepared for the questions that will always be asked of you Zoe Williams, Clinical Biometrics Manager, LEO Pharma Herbert Noack, Vice Chair CDISC E3C & Project Statistician – Showcasing Metadata Repositories as a Focus Medical Affairs, Boehringer Ingelheim of Pharma/Biotech Companies The Alpha And The Omega – End To End CDISC Alignment 14.40 CASE STUDY: Getting the most out of CDASH and SDTM:09.50 CASE STUDY: Implementing Standards End-To-End On A automating the specification and validation process Global Scale: The Genzyme Experience w Understanding how and why upfront implementation of the data w Introduction to Genzyme’s GetSMART initiative, a Strategic, standards in your data management and statistical environment is Measurable, Achievable, Realistic and Time-based program, to beneficial implement global w Utilising data standardisation to better enable the automation of the w Achieving the GetSMART Vision through structured content exchange of specifications and instructions to internal and external management, data collection and processing, analysis and partners reporting, core infrastructure and standards governance w Implementing a central data standards library and metadata w Realising the benefits of upstream CDISC standardisation in repository to generate study specifications and verify study data and providing measureable downstream benefits for products utilising metadata against the specifications and the data model defined standard CDASH CRFs and SDTM implementations Peter Van Reusel, CDISC E3C Member and Business Unit Director of w Understanding how to mature standards implementation through CRO Services, Business & Decision on-going activities classified into three categories: standards 15.10 Networking Coffee Break development, standards governance and technology-enabling Sue Dubman, Senior Director, Standards and Architecture, Genzyme 15.40 CASE STUDY: Standardisation Of SDTM Mappings At Roche w Assessing experiences of creating a new set of standards in a large10.30 Networking Coffee Break pharmaceutical environment and what processes were followed Data Warehousing And CDISC: The Cost/Benefit Analysis w Exploring a number of specific examples of where data collection/11.00 Presenting The Business Case For Standardised Clinical protocol requirements led to challenges in mapping to SDTM and Data Within A Pharma Company implemented solutions w The challenges of standardising clinical data for statistical analysis w Analysing possible options to best handle change management w Considerations for modelling a clinical data warehouse w Examining the challenges involved in implementation of change w Project management aspects of standardising analysis datasets for management and lessons learned multiple studies Chris Price, Senior Technical Programmer, Roche w The role of CDISC standards in clinical data standardisation and warehousing 16.20 CASE STUDY: Eli Lilly’s Adoption Of The Operational Paul Vervuren, Head Scientific Programming Women’s Health & Data Model Endocrine, MSD w Exploring the rationale for adopting ODM Roundtable Discussions w Understanding the challenges involved in customisation (including11.40 Participants will be able to choose 1 of the 4 different some ODM gaps) w Making a proprietary ODM library SDTM-friendly roundtables and spend an hour dis cussing one of the w What Eli Lilly has gained from converting to ODM topics outlined below: w Why Eli Lilly made the ODM library an Open Source resource A The Open Source Future of CDM? w Casting a critical eye to the future: extending into a study design model Bruce Basson, Statistician, Eli Lilly Bruce Basson, Statistician, Eli Lilly B Functional Vs. Full Outsourcing - Evaluating The Best Approach For Your Company 17.00 Closing Remarks from the Chair and End of Conference Berthold Traub, Associate Director, Nycomed GmbHPre-Conference Workshop Day: 6th June 2011A) 10.00-13.30 B) 13.45 – 18.00 CDISC Workshop – Introduction, Implementation and Integration and Interoperability: HL7 Workshop Future Developments In this interactive workshop session HL7 board members Hugh Glover Peter Van Reusel, the only registered CDISC SDTM trainer in Europe, and Julie James from Bluewave Informatics will take us throughmember of CDISC E3C, CDISC SDTM team member and Business Unit a masterclass in the meaning and applications of HL7 standards in theDirector of CRO Services at Business and Decision, will facilitate an pharma/biotech/healthcare sectors. In this 4¼ hour mini-course areas ofinteractive workshop concentrating on the implementation of CDISC standards concern will include the following:in your processes. Areas covered in this 3½ hour mini-course will include: w Semantic interoperability/semantic robustness – this will be explained inw CDISC introduction, CDISC implementation strategies and CDISC future some detail and contrasted to syntactic interoperability developments 45’ w What is HL7? Participants will be given an overview of the principles ofw A data conversion methodology demo (using SAS Data Integration Studio) 45’ HL7 as a standard for achieving semantic interoperabilityw An SDTM validation demonstration 30’ q Analysis principlesw What’s new in 3.1.2: the highlights 30’ q Information modelling including use of ISO datatypes and controlledw Implementing CDASH and SDTM in Oracle Clinical / Remote Data Capture 45’ vocabularies q Dynamic modelling and architectural principles w Reading the standards - a look at the various materials and resources, focussing on the domains of immediate relevance to the Pharma industry - CTRR, ICSR, IDMP, RPS, e-Stability, SPL and particularly those currently being specified by the regulators w How should HL7 be adopted? A look at some of the practical issues involved in getting started and some principles on how to capitalise on the investment made (and some pitfalls to avoid)Tel: +44 (0)20 7368 9300 Fax: +44 (0)20 7368 9301 Email:
  4. 4. Maximise Your Involvement: Sponsorship and Exhibition OpportunitiesThe 2nd Annual Clinical Data Standardisation & Management marketing solutions targeted at industry officials and executivesevent will be attended by senior figures and decision-makers from and specifically tailored networking opportunities. Other featuresindustry, bringing buyers and suppliers together in one location. of sponsorship include:On-message and on target, the event will provide an excellent • Prominent exhibition space in the main conference networking areaplatform from which to launch new business relationships. • Participation in comprehensive pre-event marketing campaignsWith our tailored networking sessions, sponsors can achieve the • Tailored marketing strategies to suit your organisation’s size,kind of face-to-face contact that overcrowded trade shows cannot. scope and individual requirementExhibiting and sponsorship options are extensive and bespoke For more information and to discuss the right opportunity,packages can be developed to suit your individual company’s contact Diane McKenna on +44 (0)207 368 9300 orneeds. Most packages include complimentary entry passes, pharma IQWeb: Continue your learning experience with Pharma IQ online. As well as playing host to a series of global events where leading industry experts and thought leaders share their experience, knowledge and strategic thoughts, Pharma IQ also offers an online community for pharma & biotech professionals. Join now to network with your peers andaccess exclusive videos, podcasts and presentations from this and other Pharma IQ events.Join the community: Partners PhUSE is the provides a comprehensive directory on a myriad of unique features worldwide voice brings you the latest in industry of products, services, and solutions and tools, discovering meaningful that provides projects and updates, along with for the life-sciences industry. collaborations across geographic the Life Sciences the news, views and trends that To Raise Your VOICE, contact boundaries and fields of expertise.industry with the mechanism for leading professionals – from senior feedback@pharmavoice.comsharing knowledge, defining and executives to manufacturing The Society forpromoting industry standards, with managers and heads of procurement Scrip Clinical Clinical Dataa view to furthering the provision – require to stay on top of their field. Research Managementof health-care information through provides is a nonprofittechnology. PharmaVOICE global intelligence for the clinical professionalIt is an independent non-profit magazine, research outsourcing sector, organizationorganization run by volunteers and reaching more with unique coverage of market- dedicated toits purpose is to create a forum than 25,000 BPA-qualified life- sensitive data including contracts promoting excellence in clinical datafor people who manage, analyze sciences executives, is the forum between outsourcing companies management through professionaland report clinical data in the that allows business leaders to and sponsors, financial news, and development, education andpharmaceutical industry. The 2011 engage in a candid dialogue on the business-critical information on the certification. Key products andconference will be held in Brighton, challenges and trends impacting most important new clinical trials. programs include Good ClinicalUK between 9th - 12th October 2011. the industry. PharmaVOICE Data Management Practices,More information is available at provides readers with insightful and LabRoots CCDM® certification, thought-provoking commentary is a free, learning and an Annual Conference. in a multiple-perspective format social Established in 1994, SCDM currently through forums, topics, and networking site that enables has 2,600 members worldwide articles covering a range of issues scientists, engineers, and other with an interest in advancing from molecule through market. technical professionals to connect, data management practices. For PharmaVOICE subscribers are also collaborate with, and learn from additional information, please visitPharmaceutical-technology. kept abreast of the latest trends each other. LabRoots fosters world- is the only website focusing and information through additional wide scientific communicationspecifically on issues relevant media resources, including and incorporates the newestto pharmaceutical professionals WebLinx Interactive WebSeminars, social networking technologies.working with technology, be it Podcasts, Videocasts, White Papers, LabRoots allows scientists todevelopment, engineering, IT or E-Surveys and e-Alerts. Additionally, connect with each other as theyproduction. describe their research interestsWho should attend:Directors, Heads and Managers involved in clinical data management. Functions include:r Clinical Data r Informaticsr Information Management r Clinical ITLast year’s attendees came from throughout Europey Denmark: 26%y UK: 22%y Switzerland: 17%y Belgium: 5%y France: 5%y Germany: 5%y Kuwait: 5%y Spain: 5%y Sweden: 5%y The Netherlands: 5%Tel: +44 (0)20 7368 9300 Fax: +44 (0)20 7368 9301 Email:
  5. 5. Clinical Data Standardisation 5 WAYS TO REGISTER and Management 2011 Freephone: 0800 652 2363 or VENUE: America Square Conference Centre, London, UK +44 (0)20 7368 9300 MAIN CONFERENCE: 7th – 8th June 2011 PRE-CONFERENCE WORkshOPs: 6th June 2011 Fax: +44 (0)20 7368 9301 To speed registration, please provide the priority code located on the mailing label or in the box below. Post: your booking form to My registration code is PDFW 129 Wilton Road, Please contact our database manager on +44(0) 207 368 9300 or at quoting the registration Victoria, London code above to inform us of any changes or to remove your details. SW1V 1JZ Online: Register & Pay before Register & Pay before Email: PACKAGES Standard Price 25th March 2011* 29th April 2011* 6 Conference + 2 Workshops SAVE £400 SAVE £300 Team Discounts* + Full Access to Conference £2596 + VAT £2696 + VAT £2996 + VAT Teams of 3 receive 10% off, Teams of 5 receive 15% off, Teams of 7 receive Recordings 20% off Team discounts are only available on standard pricing packages and there 6 Conference + 1 Workshop** is only one discount available per person booking at the same time from the same SAVE £300 SAVE £200 company + Full Access to Conference £2197 + VAT £2297 + VAT £2497 + VAT Recordings Please note: SAVE £300 SAVE £200 All ‘Early Bird’ discounts must require payment at time of registration and before 6 Conference + 2 Workshops £2197 + VAT £2297 + VAT £2497 + VAT the cut-off date in order to receive any discount. Any discounts offered whether by (including team discounts) must also require payment at the time of registration. All SAVE £200 SAVE £100 6 Conference + 1 Workshop** £1798 + VAT £1898 + VAT £1998 + VAT discount offers cannot be combined with any other offer. 6 Conference only SAVE £100 £1499 + VAT £1499 + VAT Venue & Accommodation £1399 + VAT VENUE: 6 Workshop only** (Half Day) £499 + VAT £499 + VAT £499 + VAT America Square Conference Centre, One America Square, 17 Crosswall, London EC3N 2LB 6 Audio recordings £499 + VAT £499 + VAT £499 + VAT Tel: +44 (0) 2077067700 Email: ACCOMMODATION: Overnight accommodation is not included in the registration fee. For nearby accommodation options and best possible rates and special offers please visit Discounts This map displays live r Academic Rate/Small Biotech: If you are an academic or work for a small biotech with between 2 and 100 availability and allows you to book directly with each hotel. Alternatively, if you people, you qualify for a 50% discount. would like to book your accommodation by phone, you can call Daniel Spinner, our dedicated London concierge, on +44 20 7292 2335 quoting Special Reference *To qualify for discounts, payment must be received with booking by the registration deadline. Early booking discounts are not valid in Code M9GZ2 conjunction with any other offer. **Please select your choice of workshop: A 6 B 6 Free Online Resources To claim a variety of articles, podcasts and other free resources please Delegate Details visit Please photocopy for each additional delegate 6 Mr 6 Mrs 6 Miss 6 Ms 6 Dr 6 Other Digital Conference On CD-ROM A digital version of the conference proceedings, including all First Name Family Name presentations, is available to buy. 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