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April 3rd, 2019

Digital technologies (such as wearable devices, smartphone apps) are increasingly used in clinical research and development. Despite numerous pilot clinical studies evaluating merits of digital technologies, there is still little knowledge on how to properly design and run such studies, and how to analyse the collected experimental data. The current course will cover several important statistical aspects of clinical trials evaluating digital technologies.

Workshop Leaders:
Alex Sverdlov, Director of Biostatistics, Novartis
Yevgen Ryeznik, PhD, Uppsala University


 About the workshop leaders


Alex Sverdlov has worked as a statistical scientist in biopharmaceutical industry since 2007. He has been involved in active research on adaptive designs for clinical trials to improve efficiency of drug development. He edited a book “Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects” which was published by CRC Press in 2015. Alex’s most recent work involves design of proof-of-endpoint clinical trials evaluating digital technologies in neuroscience.

Since 2014, Yevgen Ryeznik is a Ph.D. student in Uppsala University, Uppsala. Before that, he had a 2-year experience of working as a SAS programmer and clinical data analyst in the Ukrainian department of Quartesian LLC, a CRO located in Princeton, NJ. For the last ten years, he has been actively involved in research on optimal designs and adaptive randomization for clinical trials, mainly, trials with time-to-event outcomes. Yevgen's most recent research interests are digital therapeutics and mobile health, and applications of deep learning for biopharmaceutics.

Attend this workshop if you would like to understand:

  • Potential challenges and benefits of utilizing digital technologies in clinical research
  • What trial designs are available for evaluating digital technologies
  • How to analyze data generated by digital technologies
  • Current regulatory pathways to the approval of digital therapeutics


Who should attend:

  • Biostatisticians
  • Clinical project managers
  • Clinical research advisors
  • Clinical Trials Directors
  • Clinical scientists
  • Statisticians
  • Quantitative scientists

Almac Clinical Technologies LLC; Amgen; AstraZeneca; BeiGene; Berry Consultants, LLP; Boehringer-Ingelheim; Chiesi Farmaceutici; DEBIOPHARM INTERNATIONAL SA; Dr. Willmar Schwabe GmbH & Co. KG; Eli Lilly International Corporation; European Medicines Agency (EMA); Ferring Pharmaceuticals A/S; Fraunhofer Institute for Algorithms and Scientific Computing; GCE Solutions; Glenmark Pharmaceuticals; GSK; Highbury Regulatory Science; Janssen; Lundbeck Pharma; Medtronic; Menarini Ricerche SpA; Merck & Company; Mevia; MHRA; MRC Biostatistics Unit; National Institute of Allergy and Infectious Diseases ; Orion Corporation Orion Pharma; Oslo University Hospital; Roche Products Ltd; Sanofi Aventis; SDS; TFS Trial Form Support; TFS, S.L. (CIF: B-60569175); Transgene SA; UCB Pharma Limited; University Of Bath; University of Reading; Lancaster University

Workshop programme

8:30 Registration & Coffee

9:00 Opening Remarks and Introductions

Alex Sverdlov

Alex Sverdlov, Director of Biostatistics , Novartis
View Bio

9:10 Innovative designs for developing mobile health interventions

Alex Sverdlov

Alex Sverdlov, Director of Biostatistics , Novartis
View Bio

  • Micro-randomized trials
  • MOST and SMART designs
  • Choice of sample size
  • Data analysis aspects


  • 9:50 Digital biomarkers as screening/diagnostic tools

    Alex Sverdlov

    Alex Sverdlov, Director of Biostatistics , Novartis
    View Bio

  • Challenges and opportunities
  • Classification problems
  • Building predictors of clinical outcomes
  • 10:30 Afternoon Tea

    11:00 Digital Therapeutics

    Alex Sverdlov

    Alex Sverdlov, Director of Biostatistics , Novartis
    View Bio

  • Addressing unmet medical need
  • Emerging business models
  • Clinical trials to develop digital health interventions
  • 11:40 Current regulatory landscape for digital health technologies

    Alex Sverdlov

    Alex Sverdlov, Director of Biostatistics , Novartis
    View Bio

  • Pathways to regulatory approval of a device
  • Existing regulatory guidelines
  • Examples of successful approvals
  • 12:20 Chairman’s Closing Remarks and Close of Day One

    Alex Sverdlov

    Alex Sverdlov, Director of Biostatistics , Novartis
    View Bio

    12:30 End of Workshop


    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

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    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 



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    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.


    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.


    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, SAE Media 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.


    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@saemediagroup.com

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