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With numerous challenges facing clinical research managers in the pharmaceutical and biotechnology industries, SMi‘s latest international pharmaceuticals conference Phase IV Clinical Trials, will provide all the latest information and developments in Phase IV clinical trials.

SMi’s Phase IV Clinical Trials conference offers you a top-level forum to discuss the hot topics on this subject, including:

· Project management · Regulatory Issues · Patient recruitment and retention · Marketing and commercial issues · Pharmacoeconomics

Why should you attend this event?

This comprehensive conference is organised and produced by SMi: we specialise in providing senior executives with timely, strategic and focused up to date information. SMi conferences are leading-edge business events offering delegates the opportunity to meet senior industry and government figures and seek their advice and opinions. The conference will of course also be an ideal opportunity for you to network with a focused and appropriate audience.

Please register now to guarantee your place at this important conference.

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Kathy Minter

Kathy Minter, Associate, Blandy and Blandy

9:10 POST APPROVAL STUDIES FOR CLINICAL AND COMMERCIAL SUCCESS

Gareth Lewis

Gareth Lewis, Therapy Area Team Manager,CVS, Pfizer

  • Role of clinical trials in strategic planning
  • Knowledge transfer from pre-registration studies
  • Identifying marketing goals
  • Balancing clinical and marketing goals
  • The role of investigator-led studies
  • Summary of key considerations
  • 9:40 PHARMACOVIGILANCE: USING PHASE IV CLINICAL TRIALS TO STUDY ADVERSE EFFECTS

    Dr Michèle Sangeleer

    Dr Michèle Sangeleer, Pharmacovigilance Manager, Eli Lilly

  • Potential problems with sample size in clinical trials
  • Identifying alternatives to clinical trials for investigating the safety profile of a drug
  • Providing evidence to support or disprove a suspected adverse effect through observation & surveillance
  • Building pharmacovigilance databases for specific target groups
  • 10:20 DETERMINING THE OUTCOME WITH EFFECTIVE MANAGEMENT OF LATE PHASE CLINICAL TRIALS

    Tom Ruane

    Tom Ruane, Director, Investigator Services, Quintiles

  • An overview of the past, present and future of Phase IV clinical trials
  • The importance now attributed to the successful outcome of these trials
  • How “traditional processes” of managing global, late phase studies may not be enough today
  • What strategies in the Pharma/CRO industry are currently available to achieve best results · technology · process · people
  • 11:00 Morning Coffee

    11:20 THE IMPACT OF PRIVACY AND SECURITY LEGISLATION ON THE CLINICAL RESEARCH PROCESS

    Keith Korenchuk

    Keith Korenchuk, Partner, Davis Wright Tremaine LLP

  • An overview of the healthcare privacy and security legislation (HIPPA) in the United States and its global implications
  • The impact of privacy and security legislation on the clinical research process
  • The impact of the regulatory process on the de-identification of patient identifiable information
  • A comparison of US, European and other privacy and security laws that impact the clinical research process
  • 12:00 E-TECHNOLOGY - WILL PHASE IV TRIALS BE REVOLUTIONISED?

    Kathy Minter

    Kathy Minter, Associate, Blandy and Blandy

  • Heading for the next phase - are e-trials for phase IV studies the way forward?
  • Legal issues to be considered - data protection and data security
  • The impact of this legislation on the way phase IV e-trials must be conducted - the rights of trial patients and the risks for sponsors
  • Building safeguards - what pharma companies must do in order to comply
  • 12:40 Lunch

    14:00 PHASE IV DEVELOPMENT UTILISING VIRTUAL TEAMS

    Dr Gareth E. Walters

    Dr Gareth E. Walters, Director, Regulatory Affairs & Knowledge Management, Fulcrum Pharma Developments

  • Phase IV trials make significant contributions to product licensing, marketability and customer knowledge
  • Outsourcing of Phase IV activities is an effective way of maximising the impact of a product launch and lifecycle activities without over-committing in-house resources
  • Virtual teams composed of multiple suppliers - with appropriate leadership, management and processes – are a flexible, efficient and effective out-sourcing approach
  • As illustrated by case studies, managed virtual development teams are a targeted approach to providing global data, a bridge between client head office and affiliates, as well as shared resource for development and marketing
  • 14:40 EXAMINING THE RETURN ON INVESTMENT FOR PHASE IV STUDIES

    Robert Thong

    Robert Thong, Managing Director, Phizz Rx

  • When are clinical trials best utilised to support financial goals?
  • Strategies for predicting the overall cost of Phase IV clinical trials
  • How does the cost compare to the outcome of the study results
  • Using your experience in past clinical trials to improve future Phase IV trials
  • 15:20 Afternoon Tea

    15:40 COSTING AND DELIVERING LARGE PHASE IV STUDIES

    Elizabeth Hall

    Elizabeth Hall, Director, Strategic Proposal Development, PPD Development

  • Classic features of a large Phase IV project
  • Listening to client requirements/typical misunderstandings
  • GCP/ICH issues
  • A Phase IV costing model
  • Technology deployment and resource ramp up
  • Project team experiences - comparison of 'doing' versus 'bidding'
  • 16:20 PHARMACOECONOMIC FORMULARY STRATEGIES AND EVIDENCE-BASED DECISION MAKING

    Dr Richard Wyse

    Dr Richard Wyse, Chairman, Economic Healthcare Associates

  • Challenges in pharmacoeconomic analysis
  • Formulary decision-making strategies: · published pharmacoeconomic studies · economic modelling techniques · using pharmacoeconomics to gain market access · conducting pharmacoeconomic research
  • The need for collaboration between all participants in the conduct of economic evaluations · case study examples
  • Evaluating patient outcomes in relation to the cost of alternative therapies
  • Outsoucing strategies of pharmacoeconomics
  • 17:00 Chairman's Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Julia Lloyd-Parks

    Julia Lloyd-Parks, Senior Consultant, Technomark Consulting Services

    9:10 E-CLINICAL TRIALS – CONSOLIDATING SYSTEMS AND INTERPRETING DATA

    Bruce Ramsay

    Bruce Ramsay, Director, WCI

  • Powerful players and influences in the clinical trials process
  • User friendly equipment and interfaces
  • Flexibility and customisation
  • Implementation of controlled environments for e-clinical trials
  • Authorisation of data made simpler
  • 9:40 ELECTRONIC PATIENT DIARY CARDS

    Jon Wood

    Jon Wood, Director, Global Data Management, CroMedica

  • Developing technologies
  • Return on investment
  • Logistics and design
  • Futures
  • 10:20 CONSOLIDATING CDM WITH EDM

    Dr Felicity Gabbay

    Dr Felicity Gabbay, Consultant Pharmceutical Physician, Micron Research

  • Making the transition from paper to EDM trials as smoothly as possible
  • Ensuring best quality data through validation of electronic data management systems
  • Remote data entry trials
  • The consequences of increased automation for Clinical Data Managers
  • Turning data into knowledge
  • 11:00 Morning Coffee

    11:20 ELECTRONIC COLLECTION OF PATIENT DIARY DATA USING INTERACTIVE VOICE RESPONSE SYSTEMS

    Dr Bill Byrom

    Dr Bill Byrom, EDC Business Manager, ClinPhone Group

  • A comparison of paper and electronic diary technologies
  • Ensuring data integrity
  • Real-time compliance assessment and data access
  • Pre-qualification and routing
  • Collection of health economic data
  • 12:00 SETTING-UP AND ORGANIZING PHASE IV CLINICAL TRIALS

    Dr Alan Irvine

    Dr Alan Irvine, Medical Director, Orion Clinical Services

  • Defining a global strategy of recruitment
  • Dealing with national cultural specificity
  • Ensuring fully centralised coordination and project management
  • Assessing resource
  • Controlling timelines
  • Training investigators and study team Maintaining high quality communication with the centres
  • 12:40 Networking Lunch

    14:00 INVESTIGATIVE SITE SELECTION AND PATIENT RECRUITMENT

    Dr Jörg Täubel

    Dr Jörg Täubel, Consultant in Pharmacology, Charterhouse Clinical Research Unit

  • Common recruitment problems
  • Novel recruitment strategies
  • Media available to recruiters
  • Ethical and regulatory considerations
  • Investigator or patient - who comes first?
  • 14:40 USING PRODUCT VISUALISATION TO ADD VALUE AT PHASE IV

    Dr Paul J Clewlow

    Dr Paul J Clewlow, Business Development Director, Pharmaceutical Profiles

  • Product visualisation studies during clinical development provide pivotal visual evidence of the in vivo performance of oral, pulmonary, nasal, rectal and vaginal drug dosage forms
  • “Time lapse” gamma scintigraphy images of the oral drug delivery process readily demonstrates the formulation is delivering the right dose to the desired location within the gut
  • Scintigraphic studies on radiolabelled pulmonary formulations demonstrate “proof of concept” for novel delivery devices / formulations and provide detailed information on drug elivery, distribution, deposition and clearance from the lungs
  • Imaging of technologies delivering drugs via the mucosal route shows the in vivo spreading, retention and clearance of delivery technologies and provides a fundamental understanding of how products perform
  • 15:20 Afternoon Tea

    15:40 ROLE OF REGISTRY STUDIES IN CLINICAL AND COMMERCIAL SUCCESS

    Venkatesan Thangaraj

    Venkatesan Thangaraj, Chief Technology Officer, Enmed

  • Regulatory requirements and challenges
  • Data collection, distribution and analysis
  • Managing logistics and collaborations
  • Building a global, interactive community
  • 16:20 SPEAKER PANEL

    17:00 Chairman's Closing Remarks 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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