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Following the runaway success of last years event, SMi are pleased to announce their 4th annual conference ‘Conducting Clinical Trials in Europe.’

This meeting will cover regulatory developments in the European environment with close attention being paid to the Clinical Trial Directive and it’s affect on the industry two years after its initial implementation. Recognised experts from within the EU community will share their experiences as we embark on a country by country journey to discover the impact of the directive, challenges faced and possible solutions to overcome them.

 Our influential industry panel will give best practice advice on what components are needed for a successful trial, including key requirements for good clinical practice, quality assurance and inspections for clinical trials to ensure that your company maximises patient involvement and clinical trial supply

Gain an insight into the development strategies being employed from companies in the European market!

Hear cutting edge contributions from senior industry practitioners including:

  • Dr Brian O’Neill, Global Head, CQA Management External Alliances, F.Hoffmann-La Roche
  • Professor Heinrich Klech, Senior Medical Director, Eli Lilly
  • Dr Hartwig Gajek, Medical Director, Baxter Europe
  • Dr Agnieszka Zareba, Regional Director, Clinical Research & Development, Wyeth
  • Pierre Mermet-Bouvier, Director, Wyeth Research
  • Dr Michael Herschel, Director, Clinical Research, GlaxoSmithKline
  • Estelle Fritschy, Good Clinical Practice, Quality Assurance Auditor, Actelion Pharmaceuticals
  • Dr Ian Thomson, Medical Quality Assurance Advisor, Eli Lilly
  • Dr Richard Sullivan, Director, Clinical & Translational Directorate, Cancer Research UK
  • Dr Milen Vrabevski, Chief Executive Officer, Comac Medical

Key issues to be addressed at the conference include:

EU CLINICAL TRIAL DIRECTIVE TWO YEARS ON: See what has changed from early implementation of the directive and its affect on academics and the pharmaceutical industry

QUALITY ASSURANCE: Learn from key industry experts what it takes to prepare, host and survive regulatory inspections

HAS EUROPE BECOME A BETTER PLACE FOR TRIALS? : Hear lessons learned and practical solutions to overcome the financial concerns that companies deal with when conducting clinical trials

CLINICAL TRIAL SUPPLY: Discover its implications for conducting studies in EU member states and how this is affecting major pharmaceutical companies whilst learning how to ensure maximum participation in trials

 EUROPEAN PERSPECTIVES: Listen as leading experts discuss the impact of the directive from various European countries including Germany, France, UK and Central Europe

NETWORKING OPPORTUNITIES: Collaborate with industry peers in an environment promoting information exchange

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Michael Herschel

Michael Herschel, Director, Clinical Research, GlaxoSmithKline

9:10 ENSURING A SUCCESSFUL TRIAL

Michael Herschel

Michael Herschel, Director, Clinical Research, GlaxoSmithKline

  • Patient involvement in the design of clinical trials
  • Strategies for successful patient recruitment
  • Ensuring the successful execution of the organisation’s development projects
  • Respect for the rights of study subjects
  • Principles of trial design
  • What merits success?
  • 10:30 Morning Coffee

    11:00 PREPARING FOR, HOSTING AND SURVIVING REGULATORY INSPECTIONS

  • Regulatory inspections in clinical trials
  • Complete inspection process
  • Preparing for a regulatory inspection
  • Hosting regulatory inspections
  • Common inspection findings
  • Minimising future impact
  • Ian  Thomson

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

    Mark Parry

    Mark Parry, Advisor, Medical Quality Assurance, Novartis

    11:40 THE EUROPEAN CLINICAL TRIAL DIRECTIVE

    Estelle Fritschy

    Estelle Fritschy, Good Clinical Practice, Quality Assurance Auditor, Actelion Pharmaceuticals Ltd

    12:20 Networking Lunch

    13:50 EFFECTS OF THE DIRECTIVE ON PUBLICLY FUNDED TRIALS

    Richard Sullivan

    Richard Sullivan, Director, Clinical & Translational Directorate, Cancer Research UK

  • Complying with new regulations
  • Taking advantage of the requirements that simplify the initiation and conduct of trials
  • What influence do clinical researchers hold? Can they sway the decision-making process?
  • Unnecessary delays or stoppages when conducting trials
  • Inadequate financial support for academic groups
  • Clarifying the precise requirements of the legislation for sponsors and investigators conducting non-commercial trials
  • 14:30 PATIENT RECRUITMENT

    Hartwig Gajek

    Hartwig Gajek, Medical Director, Europe, Baxter

  • Always an issue?
  • What is the real cost of resources and services?
  • Differentiating treatment costs
  • Ensuring that decision makers are consulted early in the costing and resourcing process
  • 15:10 Afternoon Tea

    15:40 PANEL DISCUSSION

  • How can we achieve harmonisation across member states?
  • Does Europe still suffer from a lack of uniformity?
  • Are there too many differences?
  • Ian  Thomson

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

    Michael Herschel

    Michael Herschel, Director, Clinical Research, GlaxoSmithKline

    Pierre Mermet-Bouvier

    Pierre Mermet-Bouvier, Director, Wyeth Research

    16:20 IMPLEMENTING THE EU CLINICAL TRIALS DIRECTIVE IN GERMANY

    Dagmar Chase

    Dagmar Chase, Managing Director, Clinrex GmbH

  • Highlights and lowlights of the German drug law after the transposition of the Directive
  • Impact of the new law on IITs
  • Where are the simplifications?
  • GCP in IITs
  • How much support can a pharmaceutical company provide for an IIT without becoming the sponsor?
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Pierre Mermet-Bouvier

    Pierre Mermet-Bouvier, Director, Wyeth Research

    9:10 REGULATIONS IN THE FRENCH MARKET

    Pierre Mermet-Bouvier

    Pierre Mermet-Bouvier, Director, Wyeth Research

  • Has there been a decrease in clinical research?
  • The impact on the cost of trials
  • Who are the ones most affected by the trial?
  • Safety reporting
  • Why France didn’t make the 2004 deadline
  • Implementation into national legislation
  • 9:50 IMPACT OF THE DIRECTIVE ON EASTERN EUROPE

    Agnieszka  Zareba

    Agnieszka Zareba, Regional Director, Clinical Research and Development, Wyeth Pharmaceuticals

  • An attractive location for trials?
  • Cost issues – can it lead to the loss of commercial research to Eastern Europe?
  • What does the directive means for Eastern Europe?
  • Understanding the various local governments and communities
  • The impact of EU regulations on clinical trials in Eastern Europe
  • Encouraging the co-operation of EU member states
  • 10:30 Morning Coffee

    11:00 HOW TO ASSURE QUALITY WHEN CLINICAL TRIALS ARE CONDUCTED IN EASTERN EUROPE

    Milen Vrabevski

    Milen Vrabevski, Chief Executive Officer, Comac Medical Ltd

  • Define the term "Eastern Countries"
  • Current CR Environment overview - conditions we work under
  • Key issues for success in CR, analysing:
  • Regulatory environment
  • Patient protection, media attitude
  • Health systems - CR environment
  • Investigators/sites - strategies for successful patient recruitment
  • CRO competence and resource
  • Import procedures
  • Infrastructure and access to new technologies etc.
  • GCP and NGO activities
  • 11:40 HAS EUROPE BECOME A BETTER PLACE FOR CLINICAL TRIALS?

    Jean-Pierre Tassignon

    Jean-Pierre Tassignon, Chairman, European Forum for Good Clinical Practice & Executive Vice President, PSI Pharma Support International

  • Key issues and problems
  • Concerns over the Directive
  • Practical solutions to meet the challenges of working to the Directive
  • Lessons learned from FDA inspections
  • Investment in clinical trials in Europe and the world
  • 12:20 Networking Lunch

    13:50 NEW REGULATORY SYSTEMS (EXPERIENCES SHARED AND LEARNED)

    David Bell

    David Bell, Medical Director, Bio-Kinetic Europe Limited

  • The MHRA and CTA applications
  • COREC the new ethics committee systems:
  • Regulatory approvals within the NHS trusts
  • Input from the CRSC
  • Considerations for streamlining the regulatory pathway
  • 14:30 CLINICAL TRIAL SUPPLY

    Brian O'Neill

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

  • Overview of relevant European regulatory framework and its implications for conducting clinical studies in EU member states
  • Managing the movement, control, and release of investigational medicinal product (IMP) into and within Europe
  • Role of the QP(s) and the importance of formalised agreements related to breakdown of responsibilities between centralised QP, national QPs, heads of local QA and responsible persons, and between sponsor and third party contractors acting on their behalf
  • Identifying and agreeing responsibilities at the GCP-GMP interface
  • Need for proper communication among all responsible for the integrity of product – tracking, and control of IMP throughout the distribution chain up to final destruction of unused product
  • 15:10 Afternoon Tea

    15:40 IMPLEMENTATION OF THE DIRECTIVE

    A Senior Director

    A Senior Director, Senior Director, Medical Affairs & Health Economics, Europe, Astellas Pharma EU Ltd

  • Significant variations in reporting procedures
  • The main benefits and disadvantages of the Directive
  • Good Clinical Practice (GMP) guidelines
  • Good Manufacturing Practice (GMP) standards for medicines used in trials
  • The responsibility of sponsors
  • Regulatory guidelines
  • Impact of the directive on members of the public
  • 16:20 EUROPEAN RECRUITMENT PROGRAMMES

    Richard  Anderson

    Richard Anderson, Chief Executive Officer, De Facto Communications

  • Involving patients upfront
  • Learning how they think
  • Patients and investigators – contrasting views on recruitment
  • Putting an effective programme into place
  • 17:00 Chairman’s Closing Remarks and Close of Conference

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    Workshops

    Good Clinical Practice
    Workshop

    Good Clinical Practice

    Crowne Plaza Hotel - The City
    27th October 2006
    London, United Kingdom

    Crowne Plaza Hotel - The City

    19 New Bridge Street
    London EC4V 6DB
    United Kingdom

    Crowne Plaza Hotel - The City

    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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