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Clinical trials are an integral part of the development of new pharmaceutical products. In the light of increasingly strict regulatory guidelines, together with pressure to reduce the length and cost of research and development, shorten product lifecyles and respond to increasing shareholders’ demands, companies are being forced to rethink their clinical research strategies. SMi has identified the need to evaluate the different forms of contract available, to review regulations and legislation and to discuss how best to negotiate the optimal contract for sponsor, clinical research organisation and investigator. Such negotiations can be complex, encompassing a number of different perspectives, but are critical in order to ensure a competitive edge in today’s fierce drug market.

SMi appreciate the need to keep up to date with developments in this field. You will be given the chance to meet with your peers and exchange ideas that will help carry clinical trials into the future.

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Steve Powell

Steve Powell, Vice President & General Manager, International Operations, Phase Forward

9:10 FOCUSSING ON THE DESIRED DELIVERABLE

Carl Emerson

Carl Emerson, Senior Contracts Manager, Celltech

  • Clarifying why the study is to be undertaken
  • Establishing the correct detail level of the scope to be included
  • Getting appropriate control across the whole project team
  • Accountability and empowerment for sponsor and CRO
  • What are the appropriate measures to include to make sure all is on track
  • Strategies for getting delivery
  • 9:40 MERITS OF THE MASTER SERVICE AGREEMENTS AND PREFERRED PROVIDER AGREEMENTS

    John Porter

    John Porter, Director, Clinical Outsourcing, Pharmacia

  • What is a master service agreement?
  • Negotiating a sound agreement to satisfy all parties
  • How does this contract affect the provision of services?
  • Speeding up the contracting process
  • The advantages of drawing up a master service agreement or preferred provider agreement
  • Potential drawbacks of the agreement
  • 10:20 OUTSOURCING: THE FUTURE

    Steve Powell

    Steve Powell, Vice President & General Manager, International Operations, Phase Forward

  • What factors produce the need to outsource? How will they change?
  • What can we expect from clinical trials of the future?
  • What will be the future success factors?
  • What will the pharma industry require from its suppliers?
  • Will there be any room for commodity purchasing?
  • Who will survive?
  • 11:00 Morning Coffee

    11:20 GETTING TO CONTRACT FASTER

    Kristine Friend

    Kristine Friend, Director, Global Proposal Development, Omnicare Clinical Research

  • RFIs
  • Bid specifications
  • Proposal requirements
  • Standardised contracts
  • Preferred pricing
  • 12:00 CREATING, MAINTAINING AND MANAGING THE SPONSOR-CRO RELATIONSHIP FOR OPTIMAL RESULTS

    Dr Steven Chmielewski

    Dr Steven Chmielewski, Clinical Project Management Centre of Excellence, Eli Lilly & Company

  • Creating a true partnership environment versus a master/slave or us/them type of disfunctional relationship
  • Emotional and professional maturity: solving problems and avoiding the ‘blame game’ or finger pointing trap
  • Optimising operational efficiencies through common language, expectations and measurements
  • Promises made, promises kept: the importance of open, honest communication and feedback
  • Information overload: identifying, resolving, capturing and disseminating lessons learned or best practices within large organisations
  • 12:40 Lunch

    14:00 RISK SHARING

    Christine Pierre

    Christine Pierre, President & Chief Executive Officer, Rx Trials

  • Re-engineering the contract for risk sharing
  • Setting up a clinical trial for shared risk achievements
  • What are the benefits of shared risk contracts for all parties?
  • What are the metric which can be measured to structure a ‘fair’ deal for all?
  • Incentives: it’s an option but what works and what shouldn’t be offered?
  • 14:40 WORKING WITH A CENTRAL LABORATORY

    Dr Daniel Chapple

    Dr Daniel Chapple, Business Development Officer, CentraLabS

  • What central laboratories can offer
  • CentraLabS experience of sponsor needs
  • The relationship between SMO and central laboratory
  • CentraLabS experienced of assembling a global alliance
  • Problems that central laboratories encounter
  • Preferred provider agreements: advantages and disadvantages for central laboratories
  • 15:20 Afternoon Tea

    15:40 THE SITE MANAGEMENT ORGANISATION PERSPECTIVE

    Dr Renny Leach

    Dr Renny Leach, Managing Director, Intercern Clinical Research Solutions

  • Effect of SMOs on early product launch, patient recruitment and site selection
  • Providing quality, reliable information
  • Interactions with CRO and sponsors: ensuring good communications
  • Assuring SMO performance
  • How far can SMOs be held responsible?
  • 16:20 CONTRACTING WITH SMOS

    Dr G Paul Evans

    Dr G Paul Evans, Managing Director, Synexus

  • Why are SMOs different to traditional sites in their needs and expectations?
  • Common problems in negotiating SMO contracts
  • What are the benefits to both parties of more appropriate contract terms?
  • Does working with SMOs offer the opportunity to alter the balance of risk between sponsor and site?
  • Defining deliverables at the site
  • Are outcomes based contracts at the site level possible?
  • 17:00 Chairmans Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Dr Bill Byrom

    Dr Bill Byrom, Director, Product Development, ClinPhone

    9:10 MAXIMISING THE POTENTIAL FOR OUTSOURCING

    Dr Flic Gabbay

    Dr Flic Gabbay, Consultant Pharmaceutical Physician, Micron Research

  • Changing opportunities: using outsourcing to maximise pharma R&D and marketing
  • Current approaches to using CROs to maximise contractual efficiency
  • What constitutes a successful CRO financially and contractually?
  • Current CRO organisational structures and models
  • The impact of CROs of changes in pharma companies in markets
  • 9:40 EFFICIENT PHASE I OUTSOURCING

    Jerry Snoeks

    Jerry Snoeks, Associate Director, Global Strategic Outsourcing, Johnson &Johnson

  • Differences between Phase I and Phase II-III clinical studies
  • Challenges in outsourcing
  • Decentralisation versus centralised outsourcing?
  • Selection of preferred providers
  • Contract negotiations
  • 10:20 E CLINICAL TRIALS

    Andrew Newbigging

    Andrew Newbigging, Managing Director, InferMed

  • The current position of e clinical trials in the pharmaceutical industry
  • The electronic age: a process change
  • Improved medical monitoring of data: integrating data from all sources
  • Software solutions tailored for data capture and management from e clinical trails
  • Standards, regulations and guidelines
  • 11:00 Morning Coffee

    11:20 CONTRACTING ON E CLINICAL TRIALS

    Dr Alice Robertson

    Dr Alice Robertson, Vice President, Clinical Operations, etrials

  • Contracting options
  • Optimising use of electronic systems
  • Integrating different electronic solutions
  • Reducing costs through process development
  • Negotiating costs and identifying cost hotspots
  • 12:00 CLINICAL TRIAL CONTRACTING: PATIENT RECRUITMENT

    John Dent

    John Dent, Manager, Product and Partnership Development, BBK Healthcare

  • Performance-based, risk sharing model
  • Volume based model
  • Preferred vendor model
  • Contingency approach
  • Study considerations: economies of scale
  • Evaluation and measurement
  • 12:40 Lunch

    14:00 PSYCHOGRAPHIC RESEARCH

    Molly Matthews

    Molly Matthews, President, Matthews Media Group

  • Psychographic segmentation now being applied to clinical trials recruitment
  • Using focused market analysis to target populations, distinct sub-groups with shared values emerge
  • Creating recruiting messages specific to those populations increases effectiveness of the recruitment process
  • Traditional formative research may be used in conjunction with high-tech applications to improve enrollment retention efforts
  • Differences between recruitment and enrollment is often understanding the target audience
  • 14:40 AN OVERVIEW OF LEGAL MATTERS RELATING TO CLINICAL TRIALS

    Ben Goodger

    Ben Goodger, Partner, Willoughby and Partners

  • Keeping to good clinical practice (GCP) regulations
  • Protecting the well-being of trial subjects
  • Protection against liability
  • Intellectual property rights and clinical trials
  • The impact of the EU clinical trial directive on conduct of clinical trials
  • 15:20 LEGAL ISSUES AND NEW AREAS OF CONCERN FOR CONTRACTING AND NEGOTIATING CLINICAL TRIALS

    Dorothy McKelvin

    Dorothy McKelvin, Contracting Officer, National Institute of Child Health & Human Development, National Institute of Health

  • Protection of human subjects
  • Regulations governing contracts
  • Legal issues of major concern when contracting
  • Regulations governing shipping and handling of samples & specimens
  • Areas of current interest
  • 16:00 Chairman's Closing Remarks and Close of Conference

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    Workshops

    Contracting and Negotiating in Outsourcing Your Clinical Trials
    Workshop

    Contracting and Negotiating in Outsourcing Your Clinical Trials

    The Hatton, at etc. venues
    14th May 2002
    London, United Kingdom

    Patient Recruitment Strategies for Clinical Trials
    Workshop

    Patient Recruitment Strategies for Clinical Trials

    The Hatton, at etc. venues
    17th May 2002
    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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