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This conference will provide attendees with an update of the EU Clinical Trial Directive 18 months on, outlining the latest information regarding the interpretation and enforcement of these regulations. This event will address the problems that have occurred since implementation and devising strategies for compliance together with practical steps to ensure compliance..

Discussing the impacts of the EU Clinical Trial Directive on the enlarging EU this event will discuss the following key issues with country specific case studies from top pharmaceutical companies and ministries of health- what will the Directive mean for Central and Eastern Europe? What issues and problems have been raised and how have they been overcome? The conference will include opinions from the European regulatory/government bodies, GCP Inspectors, and pharmaceutical companies alike as we determine how the Europe industry has been affected since its implementation.

"A must attend event complete with leading industry experts in the field discussing the latest issues surrounding conducting clinical trials in Europe."

A unique opportunity to learn from leading industry experts including:

  • Dr Elaine Godfrey, Pharmaceutical Assessor, Medicines & Healthcare products Regulatory Agency (MHRA)
  • Dr Michael Herschel, Director, Clinical Research, GlaxoSmithKline
  • Prof Heinrich Klech, Medical Director, Eli Lilly
  • Dr Hartwig Gajek, Medical Director, Europe, Baxter Bioscience
  • Dr Bernard Hart, Director, Clinical Science, AstraZeneca
  • Dr Brian O’Neill, Global Head, CQA External Alliances, F. Hoffmann-La Roche
  • Dr Beatrice Oberlé-Rolle, Head, EU Liason, Centralised Programme Management, Novartis
  • Mireille Collombat, Head, EU Liason, Novartis
  • Dr John Bolodeoku, Senior Director, Medical Affairs & Health Economics, Europe, Astellas Pharma Europe
  • Dr Ajay Duggal, Medical Director, Renal, Genzyme
  • Dr Ian Thomson, Medical Quality Assurance Advisor, Eli Lilly

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Heinrich Klech

Heinrich Klech, Medical Director, Eli Lilly

9:10 THE EU CLINICAL TRIAL DIRECTIVE

Elaine Godfrey

Elaine Godfrey, Pharmaceutical Assessor, Medicines And Healthcare products Regulatory Agency

  • The purpose of the new Clinical Trials Directive
  • Meeting the new requirements for chemical authorisation and conduct
  • Understanding the impact the Directive will have on running clinical trials
  • Explanations of the key differences between ICH, GCP and the new EU Directive
  • 9:50 PREPARING FOR THE INSPECTION PROCESS

    Ian  Thomson

    Ian Thomson, Medical Quality Assurance Advisor, Eli Lilly & Company

  • Inspection procedures
  • Common pitfalls
  • Development of international conventions
  • Public protection
  • Educational/knowledge opportunities
  • Effective preparation
  • 10:30 Morning Coffee

    11:00 HOW TO ACHIEVE QUALITY AND EXCELLENCE IN CLINICAL TRIALS

    Christa Janko

    Christa Janko, Operational Manager, Vienna School Of Clinical Research

  • Legal requirements
  • Best practice to train investigators and sponsor personnel
  • How to obtain standardisation and academic certification
  • Optimised learning techniques
  • Example of the Vienna School of Clinical Research
  • 11:40 THE ROLE OF FUNCTIONAL IMAGING IN DRUG DEVELOPMENT

    David Brooks

    David Brooks, Hartnett Professor of Neurology, GE Healthcare

  • Proof of principle
  • Microdosing
  • Dose occupancy profiles
  • Monitoring disease progression and inflammation
  • 12:20 Networking Lunch

    13:50 EXPERIENCES IN THE NEW MEMBER STATES

    Mireille Collombat

    Mireille Collombat, Head, EU Liason, Novartis

    14:30 ONE AND A HALF YEARS OF THE EU CLINICAL TRIALS DIRECTIVE

    Beatrice Oberle-Rolle

    Beatrice Oberle-Rolle, Head, EU Liason - Centralised Programme Management, Novartis

  • What does the situation look like?
  • Experiences so far
  • Problems encountered
  • 15:10 Afternoon Tea

    15:40 THE UK MARKET

    Tina Barton

    Tina Barton, Client Relationship Director, Convance Consulting Services

  • The new approval processes
  • Impact on phase I trials
  • Patient recruitment
  • Increasing costs?
  • The UK's position in comparison to the other European countries under the Directive
  • The UK's position in comparison to the other regions (Americas, Asia Pacific)
  • Pros and cons of clinical research in the UK in light of the new Directive
  • 16:20 THE GERMAN MARKET

    Dagmar Chase

    Dagmar Chase, Managing Director, Clinrex

  • Time frames and procedures
  • Particularities to watch out for
  • Flexibility of interpretation and implementation
  • Necessary procedure revision
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Hartwig Gajek

    Hartwig Gajek, Medical Director, Europe, Baxter

    9:10 GLOBAL PLACEMENT OF CLINICAL TRIALS

    Bernard Hart

    Bernard Hart, Director, Clinical Science, AstraZeneca

  • Key drivers for clinical trials
  • Approval of trials
  • Ethical authorisation of trials
  • Delivery
  • Adherence to GCP
  • 9:50 PANEL DISCUSSION

  • Are the Government restrictions on the manufactures necessary?
  • Preparing for the inspection process
  • Reducing approval times under the EU Direcitve
  • Brian O'Neill

    Brian O'Neill, Global Head, CQA External Alliances, F.Hoffmann-La Roche

    Ajay Duggal

    Ajay Duggal, Medical Director, Renal, Genzyme

    10:30 Morning Coffee

    11:00 THE IMPLEMENTATION OF THE EU CLINICAL TRIALS DIRECTIVE

    John Bolodeoku

    John Bolodeoku, Senior Director, Medical Affairs & Health Economics, Europe, Astellas Pharma Europe

  • How is the Clinical Trials Directive viewed under the pharmaceutical industry?
  • The Directive and Good Clinical Practice
  • The new clinical research environment created by the Directive
  • Is there a problem with inconsistent implementation of the Directive across Europe?
  • 11:40 EXPERIENCE WITH THE CLINICAL TRIALS DIRECTIVE

    Ajay Duggal

    Ajay Duggal, Medical Director, Renal, Genzyme

  • Some variation in adoption of the Directive into national legislation
  • Unforeseen delays in specific countries
  • Increase in administrative burden
  • MS have been very helpful
  • General overview of specific experiences relating to GCP, GMP, PV will be discussed
  • 12:20 Networking Lunch

    13:50 EXAMINING THE IMPACT OF THE EU CLINICAL TRIALS DIRECTIVE ON ACADEMIC CLINICAL RESEARCH

    Brian O'Neill

    Brian O'Neill, Global Head, CQA External Alliances, F.Hoffmann-La Roche

  • The regulatory environment and its consequences for academic clinical research
  • Sponsor responsibilities - requirement or not for single sponsor in the EU
  • Specific concerns of academic resaerch related to the conduct and management of clinical trials
  • Proposed solutions for addressing the concerns raised
  • 14:40 WINNING PATIENTS

    Michael Herschel

    Michael Herschel, Director, Clinical Research, GlaxoSmithKline

  • Patient expectations
  • Experiences with the internet
  • Learning to convince
  • Is there low-cost recruitment?
  • 15:40 ETHICS COMMITTEES AND GLOBAL PATIENT RECRUITMENT

    Jaime Cohen

    Jaime Cohen, Global Operations, BBK Healthcare

  • Ethics Committee operations in 6, 7, and 8, as they relate to patient recruitment
  • Myths and realities of using patient recruitment "tactics" – whether at the site level or in the mass media – to help educate and interest patients in clinical research
  • Research findings from an EU-wide survey of Ethics Committee members on their committee’s structure and timelines, as well as what recruitment materials and messages are permitted
  • Other topics will include: review time cycles, allowances for patient communication about clinical studies, interpretation of the detailed guidance in article 8, and implementation of the "single opinion"
  • 16:20 INVESTIGATOR INITIATED TRIALS AND THE EUROPEAN CLINICAL TRIALS DIRECTIVE

    Hartwig Gajek

    Hartwig Gajek, Medical Director, Europe, Baxter

  • What has changed for the investigator?
  • What has changed for the industry?
  • Is this the end of independent academic research?
  • How the new rules may affect the relationship between clinician and industry
  • Is there a way out of the dilemma?
  • 17:00 Chairman’s Closing Remarks and Close of Day One

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    Workshops

    Good Clinical Practice
    Workshop

    Good Clinical Practice

    Jurys Great Russell Street Hotel
    28th October 2005
    London, United Kingdom

    Jurys Great Russell Street Hotel

    16-22 Great Russell Street
    London WC1B 3NN
    United Kingdom

    Jurys Great Russell Street Hotel

    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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