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Gain an insight from the key industry speakers in the field:
  • Dr Elaine Godfrey, Pharmaceutical Assessor, Medicines & Healthcare Products Regulatory Agency (MHRA)
  • Dr Mark Lewis, Director, Analysis & Clinical Development, North West London Strategic Health Authority, NHS & Commercial Research & Clinical Trial Advisor, Department of Health
  • Ira Spector, Assistant Vice President, Clinical Trial Operations, Wyeth
  • Patricia Seymour, Senior Director, Global Investigational Supply Operations, Millennium
  • Ron Hill, Associate Director, European Clinical Trials Projects, Clinical Trials Europe & Africa, Johnson & Johnson
  • Lionel Edwards, Director, Medical Affairs, Novartis
  • Dr Ursula Streicher-Saied, Head, Global Medical Quality Management, Bayer Healthcare
  • Dr Heinrich Klech, Area Medical Director, Central/ Eastern Europe, Central Asia, Middle East & Africa, Lilly


Programme highlights:
  • EU DIRECTIVE: Interpreting the rules and clarifying the intentions of the legislation: Hear the update
  • INTERACTIVE PANEL DISCUSSION: Where does the confusion lie in connection with implementing the EU Directive?
  • COUNTRY PERSPECTIVES: Review global perspectives on the implementation of the Directive and understand how this will influence clinical trials all over Europe
  • PATIENT RECRUITMENT FOR EUROPEAN CLINICAL TRIALS: Assess the impact the ECD may have on patient recruitment and what can be learnt from US experiences
  • GLOBAL CLINICAL PROJECT MANAGEMENT: Discover how to overcome the regulatory and cultural obstacles of global clinical trials

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Lionel Edwards

Lionel Edwards, Director, Medical Affairs, Novartis

9:10 IMPLEMENTATION OF THE DIRECTIVE

Dr Elaine Godfrey

Dr Elaine Godfrey, Pharmaceutical Assessor, Medicines & Healthcare Products Regulatory Agency (MHRA)

  • Intended implementation guidelines
  • How will the national agencies interpret the legislation?
  • What is the anticipated effect on operations?
  • Getting on track to meet the deadlines
  • Identifying the leeway for implementation
  • 9:50 IMPLEMENTATION IN THE UK

    Dr Mark Lewis

    Dr Mark Lewis, Director, Analysis & Clinical Development, North West London Strategic Health Authority, NHS & ommercial Research and Clinical Trials Advisor, Department of Health, UK

  • Speed of clinical trial start-up times
  • Patient recruitment and data quality
  • Centre costs
  • The research ethics review process
  • The protection of clinical trial subjects countries
  • Impact on phase I trials
  • The UK’s position in comparison to the US and other European
  • 10:30 Morning Coffee

    11:00 IMPLEMENTATION IN GERMANY

    Dr Ursula Streicher-Saied

    Dr Ursula Streicher-Saied, Head, Global Medical Quality Management, Bayer

  • Applications to the ethics committees
  • Applications to competent authority
  • Impact on clinical development (phase I-IV trials)
  • Impact on the GCP quality system
  • 11:40 IMPLEMENTATION IN FRANCE

    Joel Guittet

    Joel Guittet, CRA Manager, Wyeth

  • The current procedures vs the previous situation
  • Impact on time to start a trial
  • The pilot phase
  • Experience gained so far on the implementation of the EU Directive 2001/20/EC
  • 12:20 Networking Lunch

    13:50 A COMPARISON WITH THE US

    Carol Greenless

    Carol Greenless, Director, Clinical Operations, CV Therapeutics

  • Acceptance of GCP
  • Clinical trial procedures in Europe compared with the US
  • Competent authority notification
  • Process for ethics committees
  • Global thinking
  • 14:30 EUROPEAN CLINICAL TRIALS

    Dr Lionel Edwards

    Dr Lionel Edwards, Director, Medical Affairs, Novartis

  • "But does Europe have enough staff to enforce? "
  • Mutual recognition of GMP, “Qualified Person” and audit inspectors
  • Is EU inspection data validation of GMP/GLP/GCP, credible?
  • EU database confidential, functional, productive and useful?
    • International ethical committees/US IRBs, acceptability?
    • Gender representation – US
    • Racial/ethnic – US
    • Lay representatives 30% (EU) Or else?
  • 15:10 Afternoon Tea

    15:40 CONDUCTING CLINICAL TRIALS IN CENTRAL & EASTERN EUROPE

    Prof Heinrich Klech

    Prof Heinrich Klech, Area Medical Director, Central/Eastern Europe, Central Asia, Middle East & Africa, Eli Lilly

  • Translation of CT directives into CEE national legislation: issues and opportunities
  • Execution and governance of CT Directive now and in the future
  • What do pharma companies have to do to be in compliance? Work on a road map
  • What does academia have to do to be in compliance?
  • Internal QC vs external governance: how to prepare for an inspection
  • What to expect in the future
  • 16:20 CLINICAL TRIALS IN EASTERN EUROPE

  • Actions needed
  • Actions taken
  • Visits needed
  • Documentation
  • Communication
  • Presentation
  • Dr Stefan Wilberz

    Dr Stefan Wilberz, Director, Clinical Development, Schwarz Pharma

    Michael Emter

    Michael Emter, Angiologist, .

    17:00 THE “THREE SIDES” OF THE SAME COIN

    Dr Gerhard Krejci

    Dr Gerhard Krejci, President, ECTA

  • The “Old EU” countries
  • The “New EU” countries (10 new members)
  • 2007 candidates and other Eastern European countries
  • 17:20 DIABETES:EVALUATING THE TRUE IMPACT

    18:00 Chairperson’s Closing Remarks and Close of Day One

    8:30 Re-registration & Coffee

    9:00 Chairperson's Opening Remarks

    Sue Sullman

    Sue Sullman, Vice President, Regulatory Affairs, Europe, Cephalon

    9:10 EUROPEAN CLINICAL TRIALS DIRECTIVE

    Dr Rachel Adams

    Dr Rachel Adams, Head, Regulatory Affairs, Antisoma

  • Strategic approach to the Clinical Trials Directive
  • Areas for review
  • Implementation
  • Experience to date
  • Impact on company and product development
  • Relationship with academia
  • Future thoughts
  • 9:50 PANEL DISCUSSION : WHERE DOES THE CONFUSION LIE IN CONNECTION WITH IMPLEMENTING THE EU DIRECTIVE?

    Dr Leyna Mulholland

    Dr Leyna Mulholland, Senior Manager, Merck

    Dr Mark Lewis

    Dr Mark Lewis, Director, Analysis & Clinical Development, North West London Strategic Health Authority, NHS & ommercial Research and Clinical Trials Advisor, Department of Health, UK

    Dr Sue Green

    Dr Sue Green, Senior Director, Regulatory Affairs, CV Therapeutics

    Dr Paul Evans

    Dr Paul Evans, Managing Director, Synexus

    10:30 Morning Coffee

    11:00 WHAT HAVE BEEN THE PROBLEMS SO FAR?

    Ron Hill

    Ron Hill, Associate Director, European Clinical Trials Projects, Clinical Trials Europe & Africa, Johnson & Johnson

  • What are the major problems?
  • Impact on the pharma industry
  • Late stage development: impact on trial management
  • Overcoming the sticking points
  • Interactions with CAs and ECs
  • Some solutions and conclusions
  • 11:40 PATIENT RECRUITMENT FOR EUROPEAN TRIALS

    Dr Paul Evans

    Dr Paul Evans, Managing Director, Synexus

  • How to target appropriate patient groups?
  • How does the Directive impact patient recruitment?
  • Are investigators disenchanted with clinical trials and if so, why?
  • Can Europe learn anything from the US experience?
  • Features of successful patient recruitment campaigns
  • 12:20 Networking Lunch

    14:00 OVERCOMING REGULATORY AND CULTURAL OBSTACLES IN GLOBAL CLINICAL PROJECT MANAGEMENT

    Dr Leyna Mulholland

    Dr Leyna Mulholland, Senior Manager, Merck

  • Utilise ICH E5 effectively to avoid duplication of clinical trials in new regions
  • Regulatory issues – compliance GCP
  • Regional recruitment differences
  • Steaming the global clinical trials process by the global team
  • Integrating information systems
  • 14:40 MANAGING INVESTIGATIONAL MEDICINAL PRODUCTS IN GLOBAL CLINICAL TRIALS

    Deirdre Przybycien

    Deirdre Przybycien, Senior Manager, Global Investigational Supply Operations, Millennium

  • Discuss impact of European Clinical Trial Directive on IMPs
  • Discuss strategies to maximise supply utilisation under the new Directive
  • Delayed differentiation
  • Global compliance
  • 15:20 ISSUES IN CLINICAL TRIALS WITH FLEXIBLE DESIGN

    Reinhard Eisebitt

    Reinhard Eisebitt, Managing Director, ClinResearch

  • Prevention of false-negative studies
  • Earlier, more reliable decisions
  • Regulatory viewpoint
  • Practical issues
  • 16:00 Chairman's Closing Remarks followed by Afternoon Tea 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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