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With six previous years of success, SMi are once again bringing together the leading professionals involved in the field of the clinical research for the annual conference on Conducting Clinical Trials in Europe.

This year’s meeting will include a breadth of issues surrounding the conduct of clinical trials in Europe, with particular focus on the use of emerging markets in tight economic times and pharmacovigilance. With input from major European experts, delegates will be provided with the opportunity to develop their perspective and share their opinions with one another on the most pressing issues within and around the field of clinical trials.

In the light of the current economic climate, the ongoing involvement of emerging markets in clinical research is more necessary than ever and this conference will address the details of clinical trials in emerging markets with some emphasis. Areas to be explored within the field of emerging markets include patient recruitment rates and operating models.

This event is a must for professionals wanting to listen to informed presentations on all aspects of clinical trials, from the orphan drug regulation to the use of modelling and biostatistics in patient recruitment, it will cater for the needs of all people involved in clinical trials.
 

IMPROVE understanding of conducting clinical trials in emerging markets
DISCOVER the developments in the uses of statistical modelling
ENSURE compliance with the EU Directive in clincal safety reporting
EXAMINE the developments in patient recruitment
HEAR about the progress of adaptive design in clinical trials 

 

  • Clinical Operations
  • Clinical Trials Logistics
  • Clinical/Investigational Supplies
  • Clinical Trials Material Management Medical
  • Clinical Quality Assurance/Quality Control
  • Clinical Research / Planning
  • Outsourcing & Procurement Managers
  • Regulatory Affairs
  • Good Clinical Practise
  • Patient recruitment
  • Adaptive design
  • Clinical Data Management
  • R&D

 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Jacek Nowak

Jacek Nowak, Executive Medical Director, Eastern Europe, Amgen

9:10 KEYNOTE PRESENTATION: EMERGING MARKETS

Jacek Nowak

Jacek Nowak, Executive Medical Director, Eastern Europe, Amgen

  • Recruitment rates
  • Efficiency metrics
  • Opportunities for strategic partnership
  • Operating models in emerging markets
  • Focus on Eastern Europe
  • 9:50 TRENDS OF THE USE OF EMERGING MARKETS IN CLINICAL TRIALS

    John Bolodeoku

    John Bolodeoku, Vice President Medical Affairs & Health Economics Europe, Astellas

  • The evolution of the use of emerging markets
  • Current patterns and trends
  • What can we expect in the future?
  • Astellas' experiences of emerging market use
  • 10:30 Morning Coffee

    11:00 SHIFTING SANDS OF THE CLINICAL TRIALS LANDSCAPE

    Dennis Joseph

    Dennis Joseph, Area Head, Country Clinical Operations, Pfizer

  • Why bother? Isn’t big beautiful?
  • What will the new footprint look like?
  • How is the new look being achieved and where are we right now?
  • How well are our new feet working?
  • 11:40 ONE SIZE DOES NOT FIT ALL

    Rob Laurens

    Rob Laurens, Associate Director, Strategy and Consultation Group, BBK Worldwide

  • Learn how each country's healthcare system, treatment and referral patterns, patient and physician attitudes, demographic and disease prevalence data, and other key variables affect patient recruitment
  • Learn how to weigh collected data in order to rank countries by recruitment suitability
  • Discuss research methods and techniques for determining key recruitment drivers for a given protocol
  • Learn how to evaluate these recruitment drivers, how to recognise the factors that can result in vastly different recruitment potentials in different countries for the same clinical protocol, and what you can do to overcome the recruitment barriers facing a given protocol
  • 12:20 Networking Lunch

    13:50 DEVELOPMENTS IN RETENTION

    J. Findlay Walker

    J. Findlay Walker, Vice President, Daiichi Sankyo Development

  • Tried and true methods
  • Innovative follow-up techniques
  • Harnessing the power of the internet
  • Minimising lost to follow up
  • 14:30 MEDICAL MONITORING FOR CLINICAL TRIALS

    Fez Hussain

    Fez Hussain, Senior Director, Medical & Scientific Services, Quintiles

  • Safety first!
  • The role of the medic
  • Laboratory surveillance
  • Does geography matter
  • A regulatory perspective through a medic's eyes
  • 15:10 Afternoon Tea

    15:40 EFFECTIVE TRIAL MANAGEMENT IN SHIFTING TO THE FULLY OUTSOURCED MODEL

    Michael Engsig

    Michael Engsig, Senior Director, Head of Clinical Operations , Nycomed

  • Changing mindset
  • Core compentences of the future CTM
  • Process re-engineering
  • 16:20 PERI-APPROVAL DEVELOPMENT STRATEGY

    Robert Miller

    Robert Miller, Chief Medical Officer, Fulcrum Pharma

  • Peri-approval studies can be a powerful life-cycle tool
  • They represent a good opportunity to raise awareness of a product and allows close collaboration with marketing companies
  • Uncontrolled they can become cumbersome and uninformative
  • Forward planning can provide an enhanced and meaningful programme fully in line with the company’s objectives
  • By this means the drug champion and the therapeutic influencers can be an important part of the life-cycle management  
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    George Corsiglia

    George Corsiglia, Senior Strategist, Strategy and Consultation Group, BBK Worldwide

    9:10 PAEDIATRIC CLINICAL TRIALS

    E. David McIntosh

    E. David McIntosh, Honorary Clinical Senior Lecturer, Imperial College

  • Waivers and deferrals
  • Update on inventory of needs
  • Networks and their benefits
  • Extrapolation using pharmacology
  • Paediatric biomarkers and surrogate markers
  • 9:50 CLINICAL TRIAL REGISTRATION

  • Keys to success
  • EU versus US requirements
  • Ways to minimise the associated risks
  • Louis-Christian Clauss

    Louis-Christian Clauss, General Co-Ordinator for Clinical and Regulatory, LFB Biotechnologies

    10:30 Morning Coffee

    11:00 STATISTICAL MODELLING

    Vladimir Anisimov

    Vladimir Anisimov, Director, Research Statistics Unit, GlaxoSmithKline

  • Main sources of uncertainty
  • Modelling and predicting recruitment at the design and interim stages
  • Assessing the number of clinical centres and adaptive adjustment
  • Predicting study performance and site productivity
  • Randomization issues in CT, impact on supply chain
  • Statistical modelling of drug supply
  • Case studies
  • 11:40 CLINICAL TRIAL SIMULATION

    Hermann Kulmann

    Hermann Kulmann, Senior Director, Global Biostatistics, Bayer Schering Pharma

  • Small number of centres with dissimilar recruitment rates
  • Inhomogeneous patient population
  • Interim analysis
  • Prediction of completers
  • Cost estimation
  • 12:20 Networking Lunch

    13:50 KEYNOTE PRESENTATION: ADAPTIVE TRIAL DESIGN

    Fiona Guillard

    Fiona Guillard, Manager, Statistics, GlaxoSmithkline

  • Advantages and disadvantages of an adaptive design
  • Considerations for an adaptive design
  • Design development and the role of simulation
  • Randomisation process
  • Regulatory aspects
  • Interpreting the results and decisions
  • 14:30 EMERGENCY MEDICAL RESPONSE FOR CLINICAL TRIALS

    Rita Fitzpatrick

    Rita Fitzpatrick, Head of Emergency Scientific and Medical Services, Guy's And St Thomas' NHS Foundation Trust

  • Emergency medical response options
  • Emergency unblinding criteria and procedures
  • Adverse event management
  • 15:10 Afternoon Tea

    15:40 CONDUCTING PAEDIATRIC CLINICAL TRIALS

    Suzana Radulovic

    Suzana Radulovic, Clinical Research Fellow , Kings College London

  • Background – the paediatric regulation
  • Ethical aspects of paediatric clinical trials
  • Clinical and practical aspects of paediatric clinical trials
  • Results of a feasibility study
  • 16:20 CLARIFYING THE ROLE AND DUTIES OF THE CLINICAL SUPPLIES COORDINATOR

  • The role of the clinical supplies co-ordinator
  • The challenges faced in this role
  • Coordinating the manufacture and supply of clinical materials
  • Liaising with external facilities
  • Conclusions
  • Martin Kristiansen

    Martin Kristiansen, Clinical Supplies Project Coordinator , Novo Nordisk

    Marianne Hansen

    Marianne Hansen, Clinical Supplies Project Coordinator, Novo Nordisk

    17:00 Chairman’s Closing Remarks and Close of Conference

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    Workshops

    The Safety Aspects of Clinical Trial Reporting in the EU
    Workshop

    The Safety Aspects of Clinical Trial Reporting in the EU

    Crowne Plaza Hotel - St James
    14th October 2009
    London, United Kingdom

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James

    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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