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Adapting new electronic systems and software applications is the key to successful data management. SMi’s Clinical Informatics conference will cover all the important topics and developments surrounding clinical data management, EDC and other e-clinical technologies.

Essential issues addressed at Clinical Informatics will include:
  • Implementation and Integration of EDC: Hear from leading industry experts on the current status of EDC and on upgrading your system
  • CDISC Standards: Learn abour CDISC standards today and those in development as well as companies experiences of adapting to them
  • Health Informatics: Find out about clinical informatics in primary and secondary care
  • Plus much more
Confirmed speakers include:

Ronald Fitzmartin, Vice President, Informatics and Knowledge Management, Daiichi Sankyo
Sylva Collins, Vice President, Global Biometrics, Kendle
Uwe Barlage, Director EDC, Bayer Vital
Michael Britt, Site Manager, System Validation Services, Roche
Rob Stackhouse,
Lead analyst, Clinical Trial Management System, Shire Pharma
Brooks Fowler, Director, Clinical Systems Operations and Global EDC Project Office, Abbott Laboratories
Glenn Ritz, Associate Technical Director, Statistical Programming, Millenium Pharmaceuticals
Sheila Bullas, Member BCS, Director, iBECK
Graham Bunn, Member CDISC, Vice President Global CRO Partnership, Medidata
Kate Trainor
, Vice President, Integration Service Group, Perceptive Informatics, Parexel
Fritz Haas,
Vice President, Information Systems, Almac Clinical Technologies
Valdo Arnera, Director, PHT Corporation
Barry Burnstead, Member CDISC, Director Project Management, i3 Statprobe
David Stein, Vice President Data Management Solutions, Clinphone
Lauren Shinaberry, Member CDISC and CDASH, Senior Manager, Clinical Data Management, PRA International

Who should attend The Clinical Informatics Conference?
You should attend this conference if you are working in the pharmaceutical or biotech industries within Clinical or Healthcare Informatics, Clinical IT, Data Management, EDC or other E-clinical Technologies.

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

David Smith

David Smith, Head of Validation Services , Roche

9:10 CURRENT STATUS OF DATA MANAGEMENT

Ron Fitzmartin

Ron Fitzmartin, Vice President, Informatics and Knowledge Management, Daiichi Sankyo Inc.

• A brief sojourn on CDM
• The strategic value of data management operations
• From in-house silo systems to outsourced cross-functional platform solutions  
• Achieving data interoperability (e.g. eCRF, CTMS, eADE,  EHR)
• Continual change in process, technology and regulations
• Clinical data informaticians embedded in clinical project teams

9:50 FULL STRENGTH EDC: THE POWER OF INTEGRATION

Fritz Haas

Fritz Haas, Vice President, Information Systems, Almac Clinical Technologies

• The current state of EDC
• EDC core technologies
• CDISC, the ODM model and the clinical data stream
• Clinical data exchange
• Upstream and downstream systems
• Case studies

10:30 Morning Coffee

11:00 CHANGE MANAGEMENT DURING THE UPGRADE OF THE EDC SYSTEM

Dr Uwe Barlage

Dr Uwe Barlage, Director EDC, Bayer HealthCare AG

  • Planning and EDC system selection
  • Implementation of EDC system update from the technical side
  • Influence of EDC system update on processes
  • Handling of running studies
  • Considerations about long term stability of current solution
  • 11:40 EFFECTIVE EDC GOVERNANCE AND MANAGING YOUR EDC VENDOR

    Brooks Fowler

    Brooks Fowler, Director, Clinical Systems Operations and Global EDC Project Officer, Abbott Laboratories

    • Ownership: IT vs. Business
    • Building ownership
    • Organizational structure
    • Role descriptions
    • Branding

    Managing Your EDC Vendor
    • Identifying key players and vertical channels of communication
    • Setting expectations
    • Transparency in pricing
    • Service level agreement

    12:20 Networking Lunch

    13:50 CLINICAL TRIAL MANAGEMENT DATA INTEGRATION AND ANALYSIS

    Rob Stackhouse

    Rob Stackhouse, Senior Business Systems Specialist, R&D IT, Shire Pharmaceuticals

    • CRO-centric clinical trial management system
    • Shire CTMS: past, present, future
    • CRO data interface and files
    • Sample trip report
    • Success factors for CTMS
    • Intelligent reporting
    • Dashboards, Answers and Delivery
    • Resource and financial management

    14:30 eCLINICAL INFORMATICS AND EDC SYSTEMS

    Dr Graham Bunn

    Dr Graham Bunn, VP Global CRO Partnerships, Medidata

    • Adaptive Clinical Trials
    • Integrated Voice Response Systems
    • Electronic Patient Reported Outcomes
    • What next?

    15:10 Afternoon Tea

    15:40 BUILDING A CLINICAL DATA WAREHOUSE

    Glenn Ritz

    Glenn Ritz, Associate Technical Director, Statistical Programming, Millennium Pharmaceuticals

    • Challenges and benefits in building a clinical data warehouse
    • Managing data from multiple sources, efficient archiving and design

    16:20 IMPROVING THE QUALITY OF CLINICAL RESEARCH THROUGH EPRO TECHNOLOGY

    Dr Valdo Arnera

    Dr Valdo Arnera, General Manager, P H T Corporation

    • Case studies about reduced variability
    • What’s in the FDA guidance about EPRO
    • Which validation is needed when shifting from paper to electronic
    • How to choose the appropriate way of collecting ePRO

    17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Fritz Haas

    Fritz Haas, Vice President, Information Systems, Almac Clinical Technologies

    9:10 CLINICAL INFORMATICS: NEW AGE OR STONE AGE?

    Dr Sylva Collins

    Dr Sylva Collins, Vice president, Global Biometrics, Kendle

    • From pencil and paper to eClinical
    • The role of vendors in eClinical support
    • Importance of compatibility of EDC systems with other aspects of eClinical technology
    • Business issues that confound successful implementation
    • Advantages of eClinical systems measured in speed, quality, and cos 

    9:50 E-FFICIENT DATA CAPTURE AND PROCESS INTEGRATION

    David Stein

    David Stein, Vice President of Product Strategy, ClinPhone Inc

    • CDISC benefits for data exchange
    • Beyond data exchange:  Process and Workflow
    • Centralized Trial Integration Platform (CTIP) philosophy (i.e. clinical middleware)
    • Benefits over point-to-point solutions
    • EDC-CTMS and EDC-IVR/IWR examples: Workflow, Cost analysis, Resource analysis
    • Future challenges for EDC
    • Moving from ASP (SaaS) to Enterprise Implementation
    • In-house implementation of eClinical Platforms
    • Adaptive Trial Designs

    10:30 Morning Coffee

    11:00 HEALTH INFORMATICS IN SECONDARY CARE

    Sheila Bullas

    Sheila Bullas, Director, iBECK

    • Overview of the current status of health informatics
    • Informatics supporting business strategy
    • Crossing the boundaries of healthcare providers
    • Transforming organisations
    • Implementing the national programme for IT

    11:40 OPTIMISING THE COST AND EFFICIENCY OF YOUR E-CLINICAL TRIALS

    Michael Britt

    Michael Britt, Site Manager, Systems Validation Services, F. Hoffmann-La Roche

  • Choosing the right technology
  • Finding the right patients and study protocol for your technology
  • The role of various parties involved, e.g. CRO, sponsor
  • Efficient cost management through partnerships
  • Clinical supply management
  • 12:20 Networking Lunch

    13:50 TURNING THE VISION INTO REALITY

    Kate Trainor

    Kate Trainor, Vice President, Integration Service Group, Perceptive Informatics, Parexel

  • Current status of EDC, IVRS, CTMS
  • The advantages and issues with current technologies
  • Next generation of e-clinical technologies – e-clinical 2.0
  • Case Study
  • 14:30 SEARCH FOR EFFICIENCIES IN CLINICAL DATA PROCESSING - UNDERPINNED BY STANDARDS

    Barry Burnstead

    Barry Burnstead, Director of Project Management, i3 Statprobe

  • End to end SDTM
  • Holistic approach to safety data management in EDC
  • Accessing medical records and HL7
  • Interfacing standards
  • Standards wish list to support future innovation
  • 15:10 Afternoon Tea

    15:40 OFFICIAL UPDATE ON THE LATEST DEVELOPMENTS AT CDISC (CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM)

    Barry Burnstead

    Barry Burnstead, Director of Project Management, i3 Statprobe

  • Details to be confirmed
  • 16:20 NEW AND EMERGING CDISC STANDARDS

    Lauren Shinaberry

    Lauren Shinaberry, Senior Manager - Clinical Data Management, P R A International Inc

  • Why more standards are needed?
  • Protocol representation group
  • Clinical Data Acquisition Standards Harmonization (CDASH)
  • Biomedical Research Integrated Domain Group (BRIDG)
  • Future strategies and business opportunities
  • 17:00 Chairman’s Closing Remarks and Close of Day Two

    +

    Workshops

    Practical approach to EDC implementation
    Workshop

    Practical approach to EDC implementation

    The Hatton, at etc. venues
    9th October 2007
    London, United Kingdom

    The interoperability of standards-based EHRs
    Workshop

    The interoperability of standards-based EHRs

    The Hatton, at etc. venues
    9th October 2007
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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