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Time is running out before the implementation deadline for the controversial EU Clinical Trials Directive. This Conference aims to evaluate the competitiveness of conducting clinical trials in Europe, looking at the current problems and assessing the challenges for trials in 2004 and beyond.

In 2003 there has been much discussion on the guidelines for the EU Clinical Trial Directive and speculation on its impact. Now it is time to evaluate how the implementation of these guidelines is going to work, identify the real problems that have been thrown up so far and devise practical strategies for compliance. The Conference will endeavour to discuss how open the Directive will be to interpretation by national agencies, how to prepare for inspections and what the implications are for trials already in progress.

The event will aim to weigh up the advantages and disadvantages of conducting trials in Europe in comparison to the US, looking at the broader issues of running trials in Europe, including issues such as patient recruitment, maintaining the necessary infrastructure, improving cost transparency and improving quality of results.

A unique opportunity to learn from leading industry experts including:
· Dr Mark Lewis, Commercial Research & Clinical Trials Advisor, Department of Health, UK
· Dr Ursula Streicher-Saied, Head, Global Medical Quality Management, Bayer
· Dr Elaine Godfrey, Pharmaceutical Assessor, MHRA
· Dr Roger Newbery, Director, Clinical Operations, Novartis
· Carlo Tomino, Head, Clinical Trials, Ministry of Health, Italy
· Dr Mark Parry, Advisor Medical, Quality Assurance, Eli Lilly
· C Marc Taylor, Head of NHS R&D Policy, Department of Health, UK
· Dr Sunil Gupta, Senior Director, Clinical Development Oncology, Sanofi-Synthelabo
· Dr Beat Widler, Global Head, Clinical Quality, F Hoffmann-La Roche

Programme highlights:
· EU DIRECTIVE: Interpreting the rules and clarifying the intentions of the legislation
· CHANGES IN GMP/GCP: Understand how to interpret the guidelines, meet the regulatory requirements and assess the impact on clinical practice
· TRIALS IN PROCESS: What will the Directive mean for European clinical research?
· APPROVAL TIMES: Strategies to reduce approval times under the new directive
· COUNTRY PERSPECTIVES: Hear global perspectives on the directive and how this will influence clinical trials all over Europe
· PANEL DISCUSSION: Current concerns in connection with implementing the EU Directive

"The timing of this conference should be perfect - shortly before the implementation of the Directive, but still enough in advance to take on board some learning"
Dr Beat Widler, Hoffmann-La Roche

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Dagmar Chase

Dr Dagmar Chase, Vice President, Kendle International

9:10 THE EU CLINICAL TRIALS DIRECTIVE

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

  • An outline of the legislation
  • Proposal to simplify and harmonise existing guidelines governing the conduct of pharmaceutical clinical trials, creating a consistent environment for clinical research across Europe
  • Giving patients involved in medical research greater protection
  • Impact on cost of running a trial in Europe
  • Impact on time taken to initiate a trial and its costs
  • A review of the timelines
    As the deadline approaches …
  • 9:40 COMPLETING THE DOCUMENTATION

    Dr Maarten Beekman

    Dr Maarten Beekman, Director, Clinical Development, Orion Pharma

  • Application to the ethics committee
  • Application to the competent authorities
  • Common pitfalls
  • The do’s and don’ts
  • 10:20 WHAT ARE THE SOLUTIONS TO THE PROBLEMS SO FAR?

    Dr Steve Pinder

    Dr Steve Pinder, Director, Regulatory Affairs, MDS Pharma Services

  • Proposals: sound and ethical?
  • Implications for applications
  • Impact on phase I – IV
  • Impact on managing a trial
  • 11:00 Morning Coffee

    11:20 PANEL DISCUSSION

    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 Steve Pinder

    Dr Steve Pinder, Director, Regulatory Affairs, MDS Pharma Services

    John Hall

    John Hall, Vice President, Operations & Managing Director, Europe, Covalent Group

    Dr Mark Parry

    Dr Mark Parry, Advisor Medical, Quality Assurance, Eli Lilly

    12:00 COMPLYING WITH GOOD MANUFACTURING PRACTICE (GMP)

    Ronnie Constable

    Ronnie Constable, Vice President, Quality & Compliance, Quintiles

  • Licensing of facilities
  • GMP regulations and guidelines
  • Role and responsibilities of the qualified person
  • Manufacture in and importation from non-EU countries
  • Quality assurance and quality systems
    Sourcing comparator products
    Qualification and validation of facilities, processes and systems
  • The GMP/GDP/GCP interface
    Mutual recognition agreements
  • 12:40 Networking Lunch

    14:00 GUIDELINES GOOD CLINICAL PRACTICE GUIDELINES (GCP)

    Dr Zoe Conway

    Dr Zoe Conway, Head of Compliance & Training for Pharma Development Operations, F Hoffmann-La Roche

  • What is the administrative burden caused by the new requirements?
  • How can sponsors deal with this? What processes and procedures need to be put in place?
  • Why is academia scared? What are the implications for investigator driven trials?
  • Are there opportunities for the sponsor? How Roche is going about the implementation of the EU CTD
  • 14:40 WHAT HAPPENS TO TRIALS IN PROGRESS?

    Griet Goddemaer

    Griet Goddemaer, Senior Director, Trial Logistics & Drug Supply, Covance

  • Overview of the national requirements
  • Impact of the guidelines and the national requirements on trials in process
  • What are the provisions for the transitional stages?
  • 15:20 Afternoon Tea

    15:40 EFFECTS OF THE DIRECTIVE ON PUBLICLY FUNDED TRIALS

    C Marc Taylor

    C Marc Taylor, Head, NHS R&D Policy, Department of Health, UK

  • Regulatory requirements
  • Increasingly expensive development
  • Different standards: different quality
  • Support for clinical effectiveness trials
  • Effect endowment of treatments
  • 16:20 UK IMPLEMENTATION PLAN AND TRANSITIONAL ARRANGEMENTS

    Dr Elaine Godfrey

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

  • Implementation of the Clinical Trials Directive in the UK
  • Timeframe for implementation
  • Transitional arrangements
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Dr Laura Brown

    Dr Laura Brown, , Course Director, School of Pharmacy, , University of Cardiff

    9:10 REDUCING APPROVAL TIMES UNDER THE EU DIRECTIVE

    Dr Sunil Gupta

    Dr Sunil Gupta, Senior Medical Director, Clinical Development Oncology, Sanofi-Synthelabo

  • Improvements in data validation
  • Availability of accurate information
  • Reducing the trial length
  • Easy interim analysis of data
  • Rapid evaluation of statistical analysis of trail results
  • Adequate infrastructure
    Identifying and managing inconsistencies
  • 9:40 PREPARING FOR THE INSPECTION PROCESS

    Dr Mark Parry

    Dr Mark Parry, Advisor Medical, Quality Assurance, Eli Lilly

  • Inspection procedures
  • Common pitfalls
  • Development of international conventions
  • Public protection
  • Educational / knowledge opportunities
  • Effective preparation
  • 10:20 PATIENT RECRUITMENT FOR EUROPEAN TRIALS

    John Hall

    John Hall, Vice President, Operations & Managing Director, Europe, Covalent Group

  • Targeting appropriate patients
  • Tailored communication
  • Patient involvement
  • Business environment and competition
  • Identification and rapid enrolment
    Recruitment and retention tools
  • Properly designed trials
    Patient protection
  • 11:00 Morning Coffee

    11:20 CONDUCTING TRIALS IN GERMANY

    Dr Ursula Streicher-Saied

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

  • Time frames and procedures
  • Flexibility of interpretation and implementation
  • Ongoing and recently completed projects
  • Necessary procedure revision
  • 12:00 CONDUCTING TRIALS IN FRANCE

    Françoise Calic

    Françoise Calic, Manager, Clinical Operations, Aventis

  • Update on French regulations
  • Impact of EU Directive on the currently revised French law pertaining to clinical trials
  • Impact on phase I trials
  • Development and progress
  • 12:40 Networking Lunch

    14:00 CONDUCTING TRIALS IN ITALY

    Dr Carlo Tomino

    Dr Carlo Tomino, Head, Clinical Trials, Ministry of Health, Italy

  • Impact of new directive
  • National rules and procedures modification
  • European and national databases on clinical trials
  • 14:40 CONDUCTING CLINICAL TRIALS IN EASTERN & WESTERN EUROPE

    Dr Natalia Fetkovska

    Dr Natalia Fetkovska, Director, Clinical Research, C&EE, Quintiles, Central & Eastern Europe

  • Contribution of C&EE to clinical studies in Europe
  • Quality
  • Timelines
  • Costs
  • 15:20 Afternoon Tea

    15:40 COMPREHENSIVE REVIEW OF CLINICAL TRIALS MANAGEMENT IN EUROPE

    Gabor Heltovics

    Gabor Heltovics, Head of business development, European Clinical Trials Association (ECTA)

  • A review of conducting clinical trials in Western Europe
  • A review of conducting clinical trials in Central Eastern Europe
  • The advantages of a new business model of international CROs to conduct clinical trials in Europe
  • 16:20 COMPARISON WITH THE US

    Dr Bernard Hart

    Dr Bernard Hart, Director, Clinical Science, AstraZeneca

  • Ethical approval
  • Global thinking
  • Standardisation
  • GCP requirements
  • Communication
  • Education and training
  • 17:00 Chairman’s Closing Remarks and Close of Conference

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    Workshops

    R&D Portfolio Management
    Workshop

    R&D Portfolio Management

    The Hatton, at etc. venues
    13th February 2004
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    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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