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In association with Cytel Inc
www.cytel.com

About the workshop

This half-day workshop will cover the latest techniques and software for accurate planning and successful execution of adaptive trials.
 
Join noted adaptive trial expert Yannis Jemiai for an in-depth look at the most effective approaches for planning and efficient implementation of adaptive trials.

In a wide-ranging format, Yannis will review current international regulatory attitudes, while also revealing methods and software specifically for planning and successfully running adaptive trials.

Actual early and confirmatory adaptive trial case studies will help illustrate how to overcome the challenges, and take full advantage of today's era of adaptive development.

Planning: how do you know you have a good design?

  • Asking the right development questions - how to avoid racing towards the wrong answer
  • The role of simulations during the design phase
  • Assessing options and determining the best design
  • Assessing the impact on the clinical development strategy
  • Working with colleagues - preparing internally for success
  • Working with regulators

Implementation: are you fully prepared to implement adaptive changes?

  • The role of simulation during the execution phase
  • Supply forecasting and cost analysis
  • Forecasting site accrual rates
  • Interim analysis - who sees what and when?
  • Protecting trial integrity
  • Implementing the recommended changes
  • New adaptive randomisation schemes
  • Final study data analysis considerations

About the host

 Yannis Jemiai

Yannis Jemiai, Associate Director of Biostatistics, Cytel Inc

Yannis has trained hundreds of statisticians and clinicians with Cytel, also consulting on early, confirmatory and seamless adaptive designs, survival studies, and trial data analysis strategies.

Yannis also oversees the progression of East®, Cytel's widely used adaptive and group-sequential design software.  He is also responsible for the development of the recently introduced SiZ® software for fixed sample trial design simulation and analysis.

Yannis is often invited to speak on innovative adaptive trial techniques and his own research has been published in numerous peer-reviewed statistical journals. Yannis earned his Ph.D. from Harvard University, an M.P.H. from Columbia University, and a B.A. in Molecular and Cellular Biology also from Harvard.
 

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Workshop programme

13:30 Registration and coffee

14:00 Welcome and introductions

14:10 Planning: how do you know you have a good design?

15:10 Afternoon tea

15:30 Implementation: are you fully prepared to implement adaptive changes?

16:30 Discussion session

17:00 Close of workshop

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Crowne Plaza Hotel - St James

Buckingham Gate 45/51
London SW1E 6AF
United Kingdom

Crowne Plaza Hotel - St James

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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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