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The purpose of the workshop is twofold, firstly to introduce the art of simulating clinical trials, and illustrating the many advantages of doing it. Secondly simulation will be demonstrated using the FACTS software (as this will allow us to specify and run simulations very quickly and visibly) and thus the workshop will show some of the capabilities of the FACTS software and how it can be used in trial design.

The workshop will help delegates understand how simulation of clinical trials is used in the trial design process and the benefits it brings – such as better understanding of operating characteristics, and allowing more complex designs that tackle contemporary problems of comparative effectiveness, efficacy/safety trade-off and sub-population selection.

Workshop programme

8:30 Registration & Coffee

9:00 Introduction to trial simulation

Tom Parke

Tom Parke, Head of Clinical Trial Solutions , Tessella Ltd

  • The simulation process
  • The design using simulation process – art and science
  • Simulation and interaction with the project team
  • 10:00 Worked example – phase 1 dose escalation using the New CRM method

    Tom Parke

    Tom Parke, Head of Clinical Trial Solutions , Tessella Ltd

  • Specifying scenarios
  • Conveying the design
  • Optimising the design
  • 10:45 Coffee Break

    11:00 Worked example – phase 2 dose finding design

    Tom Parke

    Tom Parke, Head of Clinical Trial Solutions , Tessella Ltd

  • Incremental design
  • Dose response modelling
  • Longitudinal modelling
  • Adaptive design
  • 12:00 Extending the example and the simulation process

    Tom Parke

    Tom Parke, Head of Clinical Trial Solutions , Tessella Ltd

  • Using data from pharmacometrics
  • Optimising the design in the light of the whole development program       
  • 12:45 Final Discussion/Q&A

    Tom Parke

    Tom Parke, Head of Clinical Trial Solutions , Tessella Ltd

    13:00 Close of workshop

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    Holiday Inn Regents Park

    Carburton Street
    London W1W 5EE
    United Kingdom

    Holiday Inn Regents Park

    Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

    Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

    Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

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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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