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This workshop will cover how to successfully incorporate Human Factors into the development process for connected drug delivery systems to achieve both commercial goals and meet regulatory requirements. The Human Factors engineering process and regulatory requirements for traditional medical device development are fairly well established and will be reviewed to ensure there is a common understanding of the current landscape. We will then explore how to adapt this process to meet the needs and requirements for a system which includes digital as well as physical elements.

For anyone thinking about bringing digital health solutions to market, this workshop will identify the considerations that need to be addressed when designing a comprehensive Human Factors engineering process for a system which contains both physical and digital elements, and how to leverage the tools, methodologies and best practices across device development, User Interface (UI), and User Experience (UX) development.

Executives, Directors, VPs, Heads, Principals, Managers, Scientists, Researchers of:

  • Pre-filled Syringes
  • Autoinjectors
  • Device Engineering
  • Human Factors
  • CMC
  • Injectables
  • Sterile Manufacturing
  • Packaging
  • Regulatory Affair

Previous attendees include:

Actavis; Ajinomoto Althea, Inc.; Allergan; Amgen; Aptar Pharma; AstraZeneca; Biogen; BMS; Cambridge Consultants Ltd; Catalent Pharma Solutions; Datwyler Schweiz AG; DuPont; Eli Lilly & Company; Epione BioPharmaceuticals; FDA; FDAPharma Consulting; Gateway Analytical; Genentech; Genentech Inc; Genzyme ; GSK; Heritage Pharmaceuticals ; Icon Bioscience; Insulet Corporation; Janssen R&D LLC; Janssen, Pharmaceutical Companies of Johnson and Johnson; Kappa Pharmaceuticals Limited; KBI Biopharma; KBI Biopharma, Inc.; Lupin Pharmaceuticals; Medicines Company; Medimmune; Merck & Co., Inc.; Merck, Sharp & Dohme Corp.; Merz; MITSUBISHI GAS CHEMICAL COMPANY, INC; Momenta Pharmaceuticals Inc; Nemera; Nipro; Nipro PharmaPackaging; Novavax; Novavax, Inc.; Novo Nordisk; Noxilizer Inc; Noxilizer, Inc.; Oncobiologics Inc.; Otsuka US; Overlook Industries, Inc.; Owen Mumford; Pfizer; Pfizer CentreOne; Pfizer Pharmaceuticals; Pharmascience Incorporated; Protein Sciences Corporation; Sanofi Pasteur; Sanofi S A; Schreiner MediPharm; Semigator GmbH; Sio2 Medical Products; Smithers Rapra; Team Consulting; Teleflex; Terumo Americas Holding, Inc; Terumo Medical Corporation; The Langford Research Institute; Valeant Pharmaceuticals; W.L. Gore & Associates, Inc.; West Pharmaceutical Services Inc; West Pharmaceutical Services, Inc.; West-Ward Pharmaceuticals; WL Gore & Associates Inc; Zeon Chemicals L.P.; Zoetis;
 

Workshop programme

13:30 Workshop Registration and Welcome Coffee

14:00 Workshop Leader Introduction

Melanie Turieo

Melanie Turieo, Director, Human Factors Engineering, Cambridge Consultants Ltd
View Bio

Karen Unterman

Karen Unterman, Group Leader, Human Factors Engineering, Cambridge Consultants Ltd
View Bio

14:15 Overview of Human Factors for medical development

  • Human Factors Engineering process
  • Regulatory requirements
  • Commercial goals
  • Melanie Turieo

    Melanie Turieo, Director, Human Factors Engineering, Cambridge Consultants Ltd
    View Bio

    Karen Unterman

    Karen Unterman, Group Leader, Human Factors Engineering, Cambridge Consultants Ltd
    View Bio

    14:45 Overview off the regulatory landscape for digital health

  • Is it a medical system or not?
  • Consumer digital systems
  • Medical digital systems
  • Melanie Turieo

    Melanie Turieo, Director, Human Factors Engineering, Cambridge Consultants Ltd
    View Bio

    Karen Unterman

    Karen Unterman, Group Leader, Human Factors Engineering, Cambridge Consultants Ltd
    View Bio

    15:10 Afternoon Tea and Networking Break

    16:00 Bringing digital into the HF process

  • How does it impact the process?
  • What is the UX and how is it interpreted for hybrid systems?
  • Tools, methodologies and best practices
  • Melanie Turieo

    Melanie Turieo, Director, Human Factors Engineering, Cambridge Consultants Ltd
    View Bio

    Karen Unterman

    Karen Unterman, Group Leader, Human Factors Engineering, Cambridge Consultants Ltd
    View Bio

    16:30 Validation of the digital health

    Melanie Turieo

    Melanie Turieo, Director, Human Factors Engineering, Cambridge Consultants Ltd
    View Bio

    Karen Unterman

    Karen Unterman, Group Leader, Human Factors Engineering, Cambridge Consultants Ltd
    View Bio

    17:00 Closing Remarks from Workshop Leader and End of Workshop

    +

    VENUE

    Sheraton Boston Hotel

    39 Dalton Street, Boston, MA, USA

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

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    Sheraton Boston Hotel

    39 Dalton Street
    Boston 02199
    USA

    Sheraton Boston Hotel

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    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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