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The total R&D investment of bringing a new product to market has been estimated to be close to £400 million. Delays are expensive and even a few days could potentially cost millions of pounds. Each country has its own guidelines which can be highly regulated, so it is crucial to understand the complexities of conducting clinical trials in various parts of the EU.

SMi’s 6th annual conference on Conducting Clinical Trials in Europe is a must attend event that will cover regulatory developments in the European environment whilst paying close attention to the recent inclusion of paediatric studies for all clinical trials. It will also cover various aspects of patient recruitment and retention and will analyse key logistical challenges. Recognised experts from within the EU community will give best practice advice on which components are needed for a successful trial, including key requirements for good clinical practice, outsourcing and adequate inspections to ensure your company maximises its patient involvement and clinical trial supply.



Critical challenges that will be addressed:
  • DISCOVER the importance of paediatric studies and what measures you need to take to ensure your trials are successful
  • EXAMINE the challenges and opportunities with clinical trial logistics operations and the rest of the supply chain
  • ANALYSE suitable patient recruitment and retaining strategies, and understand patient motivation
  • ASSESS the pros and cons of conducting multiregional trials and learn the value they can bring
  • DISCUSS the regulatory requirements  to ensure inspections run smoothly and how to effectively setup clinical trials in different countries



Exclusive presentations from industry experts including:
  • David McIntosh, Medical Director, Infectious Diseases (Europe, the Middle East and Africa), Wyeth Europa and Honorary Clinical Senior Lecturer, Imperial College
  • Francis P. Crawley, Executive Director, Good Clinical Practice Alliance - Europe
  • Christian Clauss, Director, NPD RA Bioscience Global, Baxter Bioscience
  • John Bolodeoku, Vice President, Medical Affairs & Health Economics, Astellas Pharma Europe Ltd.
  • Ajay Duggal, Senior Medical Director, Genzyme Europe Research
  • Hermann Kulmann, Head, Clinical Statistics Europe 1, Asia Pacific, and Japan, Bayer Schering Pharma AG
  • Henriette Fugman Bech, Senior Clinical Supply Co-ordinator, Novo Nordisk
  • Jonathan Blamey, Vice President, Product Development & Marketing, DHL Exel Supply Chain
  • Ian Thomson, Team Leader, Global Quality Auditing and Compliance, Eli Lilly & Company
  • Iman El-Hariry, Senior Director, Oncology Medicines Centre, GlaxoSmithKline
  • Johann Proeve, Global Head Data Management, Bayer Schering Pharma
  • Luke Eley, European Business Development Director, Hays Pharma
  • Renate Aloulou-Gilbert, Training Manager, GPRD Clinical Training, International Clinical Field Operations, Abbott GmbH & Co KG
  • Chris Tierney, Business Development Manager, EMEA Business Development, DHL Exel Supply Chain
  • Heike Roeder, Director, Global Head of CTS Planning, UCB Group


You will benefit from attending this event if you are:

A Vice President, Director or Head of:

  • 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
  • Business Development



Last years’ delegates included:

  • Astellas Pharma EU
  • AstraZeneca
  • Galderma R & D
  • Merz Pharmaceuticals GmBH                         
  • Genzyme Europe
  • Pfizer spol. s r.o.
  • Takeda Global Research & Development Center
  • Zeincro Hellas S.A


For Speaking opportunities please contact Robin Walsh at rwalsh@smi-online.co.uk
For Sponsorship opportunities please contact Alia Malick at
amalick@smi-online.co.uk

  • David McIntosh, Medical Director, Infectious Diseases (Europe, the Middle East and Africa), Wyeth Europa and Honorary Clinical Senior Lecturer, Imperial College
  • Francis P. Crawley, Executive Director, Good Clinical Practice Alliance - Europe
  • Christian Clauss, Director, NPD RA Bioscience Global, Baxter Bioscience
  • John Bolodeoku, Vice President, Medical Affairs & Health Economics, Astellas Pharma Europe Ltd.
  • Ajay Duggal, Senior Medical Director, Genzyme Europe Research
  • Hermann Kulmann, Head, Clinical Statistics Europe 1, Asia Pacific, and Japan, Bayer Schering Pharma AG
  • Henriette Fugman Bech, Senior Clinical Supply Co-ordinator, Novo Nordisk
  • Jonathan Blamey, Vice President, Product Development & Marketing, DHL Exel Supply Chain
  • Ian Thomson, Team Leader, Global Quality Auditing and Compliance, Eli Lilly & Company
  • Iman El-Hariry, Senior Director, Oncology Medicines Centre, GlaxoSmithKline
  • Johann Proeve, Global Head Data Management, Bayer Schering Pharma
  • Luke Eley, European Business Development Director, Hays Pharma
  • Renate Aloulou-Gilbert, Training Manager, GPRD Clinical Training, International Clinical Field Operations, Abbott GmbH & Co KG
  • Chris Tierney, Business Development Manager, EMEA Business Development, DHL Exel Supply Chain
  • Heike Roeder, Director, Global Head of CTS Planning, UCB Group


You will benefit from attending this event if you are:

A Vice President, Director or Head of:

  • 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
  • Business Development



Last years’ delegates included:

  • Astellas Pharma EU
  • AstraZeneca
  • Galderma R & D
  • Merz Pharmaceuticals GmBH                         
  • Genzyme Europe
  • Pfizer spol. s r.o.
  • Takeda Global Research & Development Center
  • Zeincro Hellas S.A


For Speaking opportunities please contact Robin Walsh at rwalsh@smi-online.co.uk
For Sponsorship opportunities please contact Alia Malick at
amalick@smi-online.co.uk

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

John Bolodeoku

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

9:10 SETTING UP A CLINICAL RESEARCH HUB IN THE UK

Ajay Duggal

Ajay Duggal, Senior Medical Director, Genzyme Europe Research

  • Overview of practical problems encountered in setting up a research hub
  • Tactics used to overcome recruitment issues and examples
  • Strategic vendor relationships and examples
  • Ensuring quality and surviving inspections
  • Practical problems associated with facilities
  • 9:50 ONCOLOGY CLINICAL TRIALS

    Iman A El-Hariry

    Iman A El-Hariry, Senior Director, Oncology Medicines Centre, GlaxoSmithKline

  • New era of targeted therapies
  • Comparison between cytotoxic and targeted therapeutics
  • Are we missing the benefit from targeted therapies
  • Learning for clinical trial design for targeted therapy
  • Case study
  • Conclusion
  • 10:30 Morning Coffee

    11:00 CHALLENGES IN LICENSING OF NEW MEDICINES WITH MINIMAL CT DATA

    11:40 LOGISTICAL OPERATIONS

    Chris Tierney

    Chris Tierney, Business Development Manager, EMEA Business Development, DHL Exel Supply Chain

  • Logistics as a key factor in deciding the clinical trial countries
  • Designing the network, including information sources
  • Partner selection and management
  • Managing timelines to ensure distribution does not affect recruitment
  • Effective reporting and management information
  • 12:00 Networking Lunch

    13:30 PANEL DISCUSSION

    Jonathan Blamey

    Jonathan Blamey, Vice President, Product Development, & Marketing, Healthcare & Technology, DHL Exel Supply Chain

  • Geographical expansion in MEA and the logistics challenges
  • Medication in, laboratory specimens out
  • Learning from other supply chains
  • 14:10 CASE STUDY

    John Bolodeoku

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

  • Details to be confirmed
  • 14:50 Afternoon Tea

    15:20 SIMULATING THE COURSE OF CLINICAL TRIALS

    Christoph Gerlinger

    Christoph Gerlinger, Senior Director, Therapeutic Area Expert Statistician, Bayer Schering Pharma

  • Avoiding failures due to improper planning
  • The importance of simulations as a planning tool
  • Simulated clinical trials to evaluate the implications of planning assumptions and predicting what happens if certain actions are taken
  • Examples of how simulation improves the transparency in the planning process to reduce the risk of failures
  • 16:00 ASSESSING EDC AS A TOOL IN DATA AND PROJECT MANAGEMENT

    Johann Proeve

    Johann Proeve, Global Head Data Management, Bayer Schering Pharma

  • The merits of electronic clinical trials
  • Understanding how technologies enhance your clinical trials processes
  • Factors which affect the success use of EDC
  • Establishing effective eClinical systems
  • 16:40 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Jonathan Blamey

    Jonathan Blamey, Vice President, Product Development, & Marketing, Healthcare & Technology, DHL Exel Supply Chain

    9:10 KEYNOTE PRESENTATION: HANDLING CLINICAL SUPPLIES

    Karen Rasmussen

    Karen Rasmussen, Project Responsible Supplies Coordinator, Novo Nordisk A/S

  • Predicting the quantities required
  • Co-ordinating the manufacture of clinical supplies 
  • Selecting appropriate packaging materials and designs
  • Managing IV/WRS
  • 9:50 KEYNOTE PRESENTATION: PAEDIATRIC AND ADULT SYNERGIES

    David  McIntosh

    David McIntosh, Medical Director, Infectious Diseases, Wyeth

  • Paediatric regulations, PIP, PDCO, PUMA
  • Inventory of needs and waivers
  • Off-patent research
  • Pharmacology, population PK and extrapolation
  • Biomarkers
  • Benefits for adults
  • 10:30 Morning Coffee

    11:00 FISHING IN THE WIDER TALENT POOL

    Luke Eley

    Luke Eley, European Business Development Director, Hays Pharma UK

  • R&D skills landscape
  • The wider talent pool by region
  • Global talent acquisition
  • The global pharma search and selection industry
  • 11:40 CONDUCTING PAEDIATRIC CLINICAL TRIALS

    12:20 Networking Lunch

    13:50 THE INSPECTION PROCESS

    Ian  Thomson

    Ian Thomson, Team leader, Global Quality Auditing and Compliance, Eli Lilly & Company

  • The regulatory framework
  • Inspection procedures
  • Managing and monitoring inspections
  • Common inspection findings
  • Keys to a successful inspection
  • 14:30 NETWORK DESIGN

    Jonathan Blamey

    Jonathan Blamey, Vice President, Product Development, & Marketing, Healthcare & Technology, DHL Exel Supply Chain

  • Supply chains in the support of clinical trials
  • Understanding organisational and study goals
  • Designing the network
  • Implementing the network
  • Importance of flexibility & agility
  • Continuous improvement to drive effective inventory utilisation
  • 14:50 Afternoon Tea

    15:20 PANEL DISCUSSION

    Chris Tierney

    Chris Tierney, Business Development Manager, EMEA Business Development, DHL Exel Supply Chain

  • Understanding your clinical trial requirements
  • Benefits of each
  • Understanding flexibility / agility requirements
  • 16:00 KEYNOTE PRESENTATION: EVALUATING THE IMPACT OF THE EU DIRECTIVE 2001/20/EC AND THE WAY FORWARD

    Francis Crawley

    Francis Crawley, Director General, Good Clinical Practice Alliance-Europe

  • Evaluating the direct and indirect impact of the Clinical Trials Directive2001/20/EC and related legislation on EU clinical trials
  • The impact of the EU paediatric regulation on clinical trials in children and adults
  • European activities to increase the role of patients and their organisations in clinical trials: assessment and impact
  • Positioning Europe in the global clinical trials market place
  • 16:40 Chairman’s Closing Remarks and Close of Conference

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    Workshops

    Conducting Paediatric Clinical Trials in the European Union
    Workshop

    Conducting Paediatric Clinical Trials in the European Union

    Marriott Courtyard Frankfurt
    8th October 2008
    Frankfurt, Germany

    Marriott Courtyard Frankfurt

    Oeserstrasse 180
    Frankfurt 65933
    Germany

    Marriott Courtyard Frankfurt

    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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