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Drug Development is a lengthy and expensive process. With the continued growth of the R&D sector, pharmaceutical companies are under pressure to enhance productivity and reduce costs and development times.

Optimising Drug Development Through Effective Data Management in Clinical Trials will explore the impact of new technological advances in information technology on the clinical trial and data management process, and how advances in electronic media can be properly utilised and integrated in order to reduce the number and duration of clinical trials needed for drug development without compromising patient safety or contravening regulations. Senior executives will present strategies on how the drug development process may be improved through the use of IT, for greater speed and efficiency of clinical data management.

Why should you attend this event? This comprehensive conference is organised and produced by SMi: we specialise in providing senior executives with timely, strategic and focused up to date information. SMi conferences are leading-edge business events offering delegates the opportunity to meet senior industry and government figures and seek their advice and opinions. The conference will of course also be an ideal opportunity for you to network with a focused and appropriate audience.

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Alan Davies

Dr Alan Davies, European Medical Director,Clinical Development , Kendle

9:10 DATA MANAGEMENT WITHIN THE CLINICAL TRIAL PROCESS

Lisa-Anne Markel

Lisa-Anne Markel, Executive Director, Global Data Management, Covance

  • Overview of clinical trials data management
  • Practical issues in data management
  • Statistical requirements of clinical trials
  • Legal issues in international clinical trials
  • Monitoring clinical trials
  • Web-based clinical trials
  • 9:40 STRATEGIES FOR IMPLEMENTING DATA MANAGEMENT STRUCTURES

    Malcolm Horseley and Andrew Gold

    Malcolm Horseley and Andrew Gold, Principal Consultants, PA Consulting

  • Common data management problems
  • Methods of improving current systems
  • Effective structure implementation
  • How to improve data quality and consistency
  • Examples and experiences from industry
  • What can we learn?
  • 10:20 STRATEGIES FOR OPTIMISING DATA COLLECTION

    Dr Edmund Otun

    Dr Edmund Otun, Managing Director, Metadata Solutions

  • Current methods implemented in data collection
  • New approaches to effective data collection and management
  • Benefits of using networked technology for data collection
  • Use of flexible data management systems throught M.E.T.I.S.
  • System implementation and improvements
  • Future of e-data collection
  • 11:00 Morning Coffee

    11:20 GLOBAL STRATEGIES IN CLINICAL DATA MANAGEMENT

    Dr Jon Wood

    Dr Jon Wood, Director, Global Data Management, Cromedica

  • The effective management of global teams
  • Challenges for distributed workflow
  • Managing outsourcing partnerships for global programmes
  • Is technology easing the burden for global data management?
  • Effective project management strategies
  • 12:00 INCREASING EFFICIENCY IN NEW DRUG APPLICATIONS BY EFFECTIVE DATA MANAGEMENT

    Dr Imogene Grimes

    Dr Imogene Grimes, Executive Director Biostatistics and Data Management, Yamanouchi

  • Defining quality
  • Levels of data validation
  • Statistical tools for data validation
  • Monitoring the queries
  • Return on investment
  • Statistics on status/quality flags
  • 12:40 Networking Lunch

    14:00 DATA MANAGEMENT SOLUTIONS

    Dr John Ryan

    Dr John Ryan, Managing Director, Plato

  • Are you getting the most from your clinical data?
  • How to ensure effective data management
  • E-solutions: how effective are they?
  • Clinical software solutions: how to make the most of your IT software
  • Data structuring: the benefits
  • E-management for the next generation
  • 14:40 INCREASING BUSINESS INTELLIGENCE THROUGH WEB-BASED DEVELOPMENT DASHBOARDS

    Dr C David Hardison

    Dr C David Hardison, VP Strategy Services and Global Clinical Development, First Consulting Group

  • What are dashboards and where is pharma implementing them?
  • What technologies can be used to develop dashboards?
  • What information should be included on a dashboard?
  • Improving data management using dashboards
  • How can real-time data be collected from operational systems and presented via the dashboard?
  • How will a dashboard impact on your clinical trial efficiency?
  • 15:20 Afternoon Tea

    15:40 IMPROVING CLINICAL DATA THROUGH EFFECTIVE PATIENT RECRUITMENT

    Dr Jörg Täubel

    Dr Jörg Täubel, Managing and Medical Director, Charterhouse Clinical Research Unit

  • Current problems in clinical trial recruitment
  • Effective patient recruitment to accelerate clinical trials
  • Considerations of recruiting on-line: pros and cons
  • Services offered by patient recruiters
  • Improved methods to attract volunteers
  • New generation of internet solutions for optimal recruiment
  • 16:20 RETAINING CLINICAL DATABASE INTEGRITY

    Barry Burnstead

    Barry Burnstead, Senior Business Consultant, Clinsoft

  • Are we assured that a common clinical data source is used for repeated submissions of the same data?
  • Single regulatory database identification and how it relates to other data collection
  • Data manipulation in SAS and the risks involved
  • Common treatment (quality checks, coding) of data regardless of source (EDC v paper CRF)
  • Data accumulation from CROs, co-developers, local group companies
  • Responding to unexpected regulatory requests
  • 17:00 Chairman's Closing Remarks and Close of Day One

    17:10 Networking Drinks Reception

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Dr Stephen Donoghue

    Dr Stephen Donoghue, Director, Clinical Affairs, Elan Pharma

    9:10 CLINICAL TRIALS IN THE INFORMATION TECHNOLOGY ERA

    Helen Parker

    Helen Parker, Development Director Webcollect Europe, Quintiles UK

  • Current information technology in clinical trials
  • Building a bridge from traditional to e-trials
  • Impact of new IT technology to date
  • How can you assess your IT requirements
  • Resourcing EDC projects with the right staff
  • Data flow in electronic trials, now and in the future
  • 9:40 USE OF ELECTRONIC DATA CAPTURE FOR CLINICAL TRIALS

    Tom Ruane

    Tom Ruane, Associate Director of Site Management, Kendle

  • Overview of electronic data capture technology
  • Current problems with data entry
  • Data quality and cost analysis: experiences at Kendle
  • Improvements in EDC technology
  • EDC applications in multinational clinical studies
  • Where next?
  • 10:20 E-CLINICAL TRIALS – INTO THE FUTURE

    Stuart Pearce

    Stuart Pearce, Team Leader, Electronic Data Capture, Pfizer

  • Globalisation and co-ordination of clinical trials
  • Manual vs electronic data entry: practical issues
  • Use of computerised systems in e-clinical trials
  • Do EDC trials improve efficiency of drug development?
  • 11:00 Morning Coffee

    11:20 SUCCESSFUL STRATEGIES FOR ELECTRONIC DATA CAPTURE INTEGRATION

    Ann-Charlotte Nylander

    Ann-Charlotte Nylander, Marketing Manager North Europe, Biomit

  • Available strategies for EDC
  • Approaches to assess electronic data capture integrity
  • Auditing computer systems used in clinical trials – tools and tips
  • How to improve current validation protocols
  • Monitoring and optimisation of EDC integrity
  • Implementation of new strategies to ensure data integrity
  • 12:00 INFORMATION SYSTEMS FOR CLINICAL TRIALS

    Dr Ursula Schwuttke

    Dr Ursula Schwuttke, President and CEO, Hightower

  • Transition from traditional data management processing to an EDC environment
  • How to manage global data: developing and utilising IT
  • Data encryption in web-based systems
  • Encoded access systems: what are the benefits?
  • Monitoring systems in data management
  • Data protection for the next generation of web-based reporting systems
  • 12:40 Networking Lunch

    14:00 E-PROCESS IN CLINICAL TRIALS

    Paul Messis

    Paul Messis, Marketing Director, TEAMworks Clinical Services

  • Why EDC?
  • Establishing the framework
  • Metrics & KPIs
  • EDC deployment model
  • Outcomes
  • Future use of EDC for trial management
  • 14:40 REGULATORY REQUIREMENTS FOR WEB-BASED CLINICAL TRIALS

    James Wang

    James Wang, Director Database Management and Programming, Allergan

  • Compliance with regulations and guidelines for e-clinical trials
  • New legislation for e-clinical trials
  • Systems validation
  • E-learning and training in clinical data management
  • Legal protection and intellectual property rights of e-clinical trials
  • Data protection and the implications for data processing
  • 15:20 Afternoon Tea

    15:40 ADVERSE DRUG REACTION REPORTING IN CLINICAL TRIALS

    Marty Boom

    Marty Boom, Senior Managing Consultant, WCI Group

  • Use of e-based ADR reporting systems
  • Implementation of e-based systems
  • Information integration throughout different therapeutic fields
  • Advantages of e-based ADR reporting systems
  • Improving consistency of ADR reporting
  • Ensuring effective communication of ADRs to regulatory bodies
  • 16:20 INTELLECTUAL PROPERTY ISSUES IN E-CLINICAL TRIALS

    Diana Sternfield

    Diana Sternfield, Senior Partner, Willoughby and Partners

  • Data protection rights: striking a fair balance
  • Evolution of the regulations encompassing e-clinical trial data
  • Existing patent protections strategies for data protection
  • Legal issues for data recycling
  • Patentable data – dispute tactics and validity
  • Commercial use: fair competition
  • 17:00 Chairman's Closing Remarks and Close of Conference

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    Workshops

    Clinical Research in the 21st Century - Is IT really the key to the future?
    Workshop

    Clinical Research in the 21st Century - Is IT really the key to the future?

    The Hatton, at etc. venues
    11th July 2001
    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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