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With the world market for pharmaceuticals at $340 billion in 1999, companies are making feverish efforts to catch a sizeable portion of this multibillion dollar pie. Indeed, as the multinational nature of the industry rapidly prevails and more and more pharmaceutical and biotechnology companies join the worldwide race towards globalisation - we ask the question: are you ready?

Globalisation largely affects the industry through mergers and the emergence of biotech consolidators, changing the balance of key players in the field. It has major impacts such as widening the gap, in terms of access to drugs, between developed and developing countries.

Why must you attend this event?

How will your company survive these changing innovations within the industry? How will you restructure your business to contend with these changes? You can begin by attending our unique conference. This meeting will provide a comprehensive forum comprising a collection of innovative presentations presented by highly acclaimed pharmaceutical executives who will address implementation of new structures, best practice strategies, novel concepts and e-methodologies necessary to give your company that competitive advantage as large-scale pharmaceutical consolidation continues to elevate.

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Zsolt Lavotha

Zsolt Lavotha, President and CEO, Lavipharm Laboratories

9:10 THE INTERNET AND THE PHARMACEUTICAL INDUSTRY

Keith Korenchuk

Keith Korenchuk, Partner, Davis Wright Tremaine LLP

  • Changing business models
  • The clinical research process
  • Strategic alliances
  • Intellectual property: the new internet currency
  • The challenge of on-line pharmacies
  • The impact of privacy legislation
  • 10:20 THE GLOBAL ACCEPTANCE AND IMPLEMENTATION OF E-TECHNOLOGY IN PHARMA INDUSTRY AND HEALTHCARE WHERE THE DRIVERS DIFFER FROM THOSE IN OTHER INDUSTRIES

    Tom Ruane

    Tom Ruane, Associate Director, Site Management, Kendle

  • The aims: speed, quality & patient recruitment
  • Defining the concept for universal acceptance and identifying the key players
  • Justifying cost of ‘new developments’ and maintaining balance with the status quo
  • Considering local and international issues
  • Measuring success – those meaningful metrics

    Clinical priorities versus clinical trial participation

  • Technology and the ‘human element’ in clinical trials

    The results: speed, quality & patient recruitment (!)

  • 11:00 Morning Coffee

    11:20 ORGANISATIONAL IMPACT OF NEW TECHNOLOGIES IN CLINICAL GLOBALISATION

    Michele Thomas

    Michele Thomas, Lead Global Database Manager, SmithKline Beecham

  • Practical transnational project team structure utilised for implementing two global data capture systems simultaneously
  • Changes in resource allocation realised with implementation of EDC technology on a global level
  • Strategic initiatives to harmonise data collection across various sources & systems
  • The role of the clinical data warehouse in achieving the clinical globalisation vision
  • 12:00 PATIENT RECRUITMENT ISSUES: FIRST STEPS

    Karen Harmes

    Karen Harmes, Director, Patient Recruitment and Retention, Acurian

  • Creating a global recruitment strategy
  • Ensuring local cultural restraints are incorporated
  • How the internet is making access to clinical trial information globally available
  • Is an internet patient an investigators nightmare?
  • 12:40 Networking Lunch

    14:00 INDIA AS A CENTRE FOR GLOBAL PHARMACEUTICAL RESEARCH AND DEVELOPMENT

    Dr Anand Tharmaratnam

    Dr Anand Tharmaratnam, Director, CNS, Clinical Development, Quintiles

    14:40 MANAGING KNOWLEDGE ON GLOBAL PROJECTS

    Dr Sandra Webb

    Dr Sandra Webb, Executive Vice President, Global Development Services, CroMedica Global

  • The impact of globalisation on internal communications and management ideas
  • Successful global project management
  • Knowledge sharing to guarantee continuous performance improvement
  • 15:20 MARKETING MIX STRATEGIES IN GLOBAL MARKETS

    Debra Gillmeister and Leigh Stewart

    Debra Gillmeister and Leigh Stewart, Director, Global Market Development and Director, Global Business Development, Baxter

  • What currently drives clinical drug delivery practice in emerging global markets
  • Clinical practice-methods of delivery of intravenous drugs with description of drug delivery systems
  • Identify key countries where opportunities are the greatest for enhanced drug delivery systems
  • Marketing opportunities for pharma companies to differentiate from competition
  • 16:00 Chairman's Closing Remarks and Close of Day One

    16:10 Networking Drinks Reception

    9:00 Re-registration and Coffee

    9:30 Chairman's Opening Remarks

    Dr John Thottathil

    Dr John Thottathil, Director, Bristol Myers Squibb

    9:40 OUTSOURCING: PLAYING THE GLOBAL FIELD

    Dr John Tottathil

    Dr John Tottathil, Director, Bristol Myers Squibb

  • What are the current drivers of outsourcing?
  • What is out there?
  • Playing the global field
  • Pros and cons of the global field
  • BMS perspective
  • 10:20 PRO-ACTIVELY MANAGING CRITICAL ACTIVITIES IN PRE-CLINICAL SUPPLIES

    Christoph Casper

    Christoph Casper, Manager, Clinical Trial Supplies, Bayer

  • Abandoning a '1 process fits all' approach and introducing seperate processes condusive to complexity of the trial
  • Redesigned the 'time critical path' so that staff had more time to deal with GMP critical activities without being pressured by the need to meet shipping timelines.
  • Radically reducing non-value adding activities
  • Ensuring new clarity through redefined GMP documents that focus on the need of the people and the process whilst staying compliant to regulatory requirements
  • Maximising new found flexibility to exceed Clinical Trial Teams expectations
  • Reducing packaging variability whilst still meeting the Clinical Trial teams requirements
  • 11:00 Morning Coffee

    11:20 EMERGING JAPANESE MARKETS

    Tetsuya Kaiso

    Tetsuya Kaiso, Team Leader, Clinical Development, Sankyo

  • How is the Japanese pharmaceutical industry responding to international challenges?
  • Advantages of this approach

    Promoted global progress

  • Enhanced marketing strength in Japan and Overseas
  • Focus on tighter integration of global operations
  • Continued to improve the company's ability to meet global healthcare need

    Difference of ethnic factors between Japanese and Western population

  • Impact of ICH E5 guideline

    Best practice case study: Sankyo

  • 12:00 LEVERAGING INTERNET CAPABILITIES TO CONSOLIDATE GLOBAL CLINICAL TRIALS

    Jorge Ferreira

    Jorge Ferreira, Global Capability Network Leader, Clinical Data Capture, AstraZeneca

  • The new paradigm - Common Information Access
  • Benefits, disadvantages and experiences so far
  • Integration - what about our in-house systems?
  • Web data capture - more than just technology changes
  • Future development
  • 12:40 Networking Lunch

    14:00 OVERCOMING THE OPERATIONAL BARRIERS TO GLOBAL ELECTRONIC DATA CAPTURE DEPLOYMENT

    Dr Richard Nelson

    Dr Richard Nelson, Senior Director, Clinical Operations Technologies, PharmaNet

  • Telephone infrastructure
  • Local internet environment: availability, reliability and cost
  • EDC study support: · Multilingual help desk (study and technical support) · Local hardware and software support
  • User training · Company staff · Site personnel
  • Local issues · Encryption · Restricted access to internet · Resistance to using EDC technology
  • 14:40 PROACTIVE DATA VISUALISATION & ANALYSIS

    Dr Ursula Schwuttke and Matt D'Ambrosia

    Dr Ursula Schwuttke and Matt D'Ambrosia, President and CEO, and Director, High Tower Software and TowerView Clinical

  • Background
  • Applications
  • Benefits
  • Challenges
  • Why now?
  • 15:20 Afternoon Tea

    15:40 E-SOLUTIONS AND ONLINE APPLICATIONS FOR BIOSCIENCE LICENSING

    Donald Masters

    Donald Masters, President and CEO, Techex

  • Addressing content and knowledge collaborations across individuals, projects and communities
  • Reducing time to market in the eR&D economy
  • Creating directed serendipity
  • Creating sustainable IP from knowledge based products
  • Leveraging IP in a global market
  • 16:20 HIGH PERFORMANCE CLINICAL DEVELOPMENT

    Fraser Skirrow

    Fraser Skirrow, Partner, Pharmaceuticals and Medical Products Practice, Accenture (Formerly Andersen Consulting)

  • Shift from product driven to patient driven strategy
  • Focus on improving success rate
  • Create a learning organisation
  • Redesign the clinical trials process
  • Support a common global regulatory framework
  • 17:00 Chairman's Closing Remarks and Close of Conference

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    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

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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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