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The multinational nature of the pharmaceutical industry and the rapid changes within global technology mean that drug development has become an expensive and lengthy process. Pharmaceutical companies are constantly looking for ways to reduce costs and hasten the process. Recent technological advances within clinical trials research and the data management process, need to be assessed for their ease of implementation and utility, and to determine their efficacy in the clinical trials process.

Clinical Trials & Data Management will address the current data management techniques employed in clinical trials, including the impact of new technological advances in information technology on the clinical trial process. The use of computer models and the real impact of electronic data management on the ease and quality of clinical trial data will also be discussed. Practicalities of managing multinational clinical trials will also be discussed, with an emphasis on regulatory issues and the intellectual property rights involved in global management of clinical trials.

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Stacey Wills

Dr Stacey Wills, Associate Director, Pharmacia

9:10 CLINICAL DATA MANAGEMENT: PAST, PRESENT & FUTURE

Hugh Donovan

Hugh Donovan, Vice President, Global Data Management / Chair, Aventis /

  • How did we get to where we are today?
  • Why do we need data management?
  • What are the challenges of today’s data management professional faces?
  • What will the future role of a data manager be?
  • What should we be doing to prepare for the changes
  • Objectives of CDM? How to meet them

    Changes in how we collect, clean, analyse and store clinical data

  • 9:40 THE IMPORTANCE OF EFFECTIVE CLINICAL DATA MANAGEMENT

    Martin Andersson

    Martin Andersson, Head of Clinical Data Management, Clinical Data Care

  • The need for data standards
  • Common data management problems
  • Controlling data
  • Techniques to avoid misinterpreting outcomes
  • More is not more
  • The importance of useful and timely information
  • 10:20 DATA PROCESSING

    Paul Athey

    Paul Athey, Principal Consultant, PriceWaterhouseCoopers

  • Information management - it’s more than just IT
  • Applying knowledge management in data management and other functions – a results driven approach
  • Who should lead knowledge management in data management and other functions
  • Making the knowledge visible
  • Concept showcase
  • Benefits and hurdles – a real world view
  • 11:00 Morning Coffee

    11:20 CASE STUDY: A SOUTHERN EUROPEAN GPRS/IPAQ RUN CLINICAL STUDY

    Colin Urquhart

    Colin Urquhart, European Sales Manager, Datatrial

  • Partnerships involved
  • Study outline
  • Challenges
  • End user feedback
  • The way forward
  • 12:00 IMPROVING DATA CAPTURE

    Hani Kamel

    Hani Kamel, Quality & Security Advisor, Novo Nordisk

  • Data validation
  • An overview of the latest data capture technologies
  • Benefits of automated data
  • Advantages of electronic data capture for data collection, management and analysis
  • Regulation guidelines and electronic data collection
  • Avoiding common mistakes in data capture
  • 12:40 Lunch

    14:00 DATA ACCURACY

    Marty Boom

    Marty Boom, Senior Managing Consultant, WCI

  • How good agreements with investigators drive data accuracy
  • Setting up trials in a way that the enable fast trial close
  • Benefits of electronic data capturing
  • Use of performance measures
  • Use of visual management tools to enhance data accuracy
  • 14:40 EFFECTIVE TRAINING ISSUES

    Dr Louise Murphy

    Dr Louise Murphy, Vice President, Clinical Informatics, ICON

  • Data Management Plan (DMP)
  • Processes and procedures
  • Data accuracy
  • Quality control systems
  • Job descriptions and core competencies
  • Training and education of data management staff
  • 14:40 PRACTICAL PROJECT MANAGEMENT

    Lisa Anne Markel

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

  • Planning and risk assessment
  • Prevention and early detection
  • Corrective action
  • 15:20 Afternoon Tea

    16:20 THE TRANSFORMATION OF CLINICAL DATA MANAGEMENT OVER THE NEXT DECADE

    Dr Ron Fitzmartin

    Dr Ron Fitzmartin, Group Executive Director, Worldwide Clinical Data Operations & Systems, Purdue

  • Meeting challenges through delivering the right information at the right time
  • Changes in how we collect, clean, store and analyse clinical data
  • Impact on the fundamental resources, processes, structures and technologies of data management
  • Will the data management function cease to exist?
  • Will the focus shift from data cleaning to knowledge delivery and management?
  • Changing the existing data management paradigm
  • 17:00 Chairman's Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Michael Tinkler

    Michael Tinkler, Vice President European Sales, Datatrak International

    9:10 CASE STUDY: IMPLEMENTATION OF A GLOBAL CLINICAL PROGRAM WITH A WEB - BASED ELECTRONIC DATA CAPTURE

    Dr Margo Taglietti

    Dr Margo Taglietti, Vice President, Clinical Research, Anti-Infectives & CNS, Schering-Plough

  • Practical advice for implementation
  • The importance of useful and timely information
  • More is not more
  • Metrics: Is success a success? If you can’t measure it, you can’t claim success
  • 9:40 EDC AND ECLINICAL A CASE STUDY

    Graham Bunn

    Graham Bunn, Global Vice President, eClinical Business, Quintiles

  • Definitions - What is EDC and what is eClinical - Comunicating eClinical to all - An achievable goal? - Stepwise approach?
  • Case Study - First 26 EDC Studies - What worked well? - What did not?
  • Implementation of eClinical - Process, process, process - Results to date
  • The Future of eClinical? - Where will it go? - When will it all end?
  • Summary
  • 10:20 HOW TECHNOLOGY CAN CHANGE THE CLINICAL PROCESS

    Dr Johann Pröve

    Dr Johann Pröve, Head, Global Data Acquisition & Management, Bayer

  • Assessing you real IT requirements
  • Current IT tools used in clinical trials
  • Interfacing the various systems in use
  • Issues related to the introduction of new technology
  • Assessing technology partners to set up clinical systems
  • 11:00 Morning Coffee

    11:20 A NEW CLINICAL TRIALS PARADIGM

    Tim Sprosen

    Tim Sprosen, Director, Product Development, Health Decisions

  • Meeting the needs of your clinical team
  • Integrating people, process and technology
  • Re-defining traditional roles
  • How to turn data into knowledge and effective decisions
  • A people and process driven technology solution
  • 12:00 USING ELECTRONIC DATA CAPTURE FOR CLINICAL TRIALS

    Dr Stephen Raymond

    Dr Stephen Raymond, Chief Scientific Officer, PHT Corporation

  • Data flow in e-trials
  • Overview of electronic data capture technology
  • Problems with data entry: eSource, realtime capture
  • Data management over the internet
  • EDC and technology
  • Successful strategies for EDC integration
  • 12:40 Lunch

    14:00 IMPROVING THE CLINICAL TRIAL PROCESS THROUGH THE USE OF ELECTRONIC SYSTEMS

    Dr Alice Robertson

    Dr Alice Robertson, Vice President, Clinical Operations, etrials

  • Decrease costs by shortening drug development timelines
  • Improve data quality using on-line systems
  • Monitor events in real time
  • Plan for process change, time spent up-front translates into increased gains later on
  • 14:40 CLINICAL INFORMATION SYSTEMS & TECHNOLOGIES

    Dr Stacey Wills

    Dr Stacey Wills, Associate Director, Pharmacia

  • Business rationale for creating a web portal system
  • Market environment
  • General format/lay-out of the portal system (and rational for its form)
  • Very brief overview of: functionality, content, navigation (and rational for each)
  • Very brief overview of: launch and early feedback with changes made to tailor solutions to users
  • Conclusions with: competitive advantage, disadvantages, considerations (e.g. costs) ROI
  • 15:20 Afternoon Tea

    15:40 DATA MANAGEMENT ON THE INTERNET

    Wilhelm Muehlhausen

    Wilhelm Muehlhausen, Associate Director, Parexel

  • Speeding up data collection
  • Security concerns
  • Compliance with regulatory requirements
  • Implementing new technologies
  • 16:20 CLINICAL TRIALS OF THE FUTURE

    Ross Rothmeier

    Ross Rothmeier, Director, Phase Forward

  • Globalisation and co-ordination of clinical trials
  • Manual versus electronic data entry
  • Processes that take advantage of technology
  • Improving efficiency of conducting clinical trials
  • Future concepts and new technology
  • 17:00 Chairman's Closing Remarks and Close of Conference

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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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