Home
overview

SMi Group is proud to present the Pre-Filled Syringes East Coast Interactive Post-Conference Workshop...

The global pre-filled syringes market was valued at $4.9 billion in 2018 and with the rapid growth of the industry, is expected to exceed $9.7 billion by 2025. With that in mind, this event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design and delivery systems within the prefilled syringe industry.

How to pass a Human Factors Validation study

Hear expert opinions on how to structure a human factors program from product conceptualization and early design through risk analysis development and iterative usability testing in order to pass a human factors validation study on the first attempt.

 

  • Learn how to build and optimize your company’s human factors and usability engineering process and how that can be applied to every development project in order to reduce development delays and improve the chances of first-time success
  • Discuss the regulatory imperative of HFE, and the focus on use-related harm, as well as other uses of HFE
  • Discuss how HFE as an R&D activity, not a documentation activity
  • Discuss development and testing of instructions for use (IFU)
  • Discuss how to scale HFE programs and how programs vary from product to product

     
  • Drug-delivery developers 
  • Medical Device Engineers 
  • Primary Packaging material designers 
  • Secondary packagers 
  • Smart device developers 
  • Training device developers 
  • Device-safety solution providers 
  • Drug developers 
  • Previous attendees include:

 

3P Innovation Ltd; Accord Healthcare; Advio Associates; ANTEV Limited; Aspen Pharmacare; AstraZeneca; Barts Health NHS Trust; Barts Health Pharmaceutics; Bayer AG; BD; BD Medical - Pharmaceutical Systems; Biocompatibles Uk Ltd; Biogen Idec; Boehringer Ingelheim Pharma GmbH & Co. KG; Clexio Biosciences; Datwyler Pharma Packaging International NV; Eveon; FRUH VERPACKUNGSTECHNIK AG; GlaxoSmithKline; GSK; GSK R&D; Harro Hofliger Packaging Systems Ltd; Harro Hofliger Verpackungsmaschinen GmbH; Harrow Hofiger; Horizon Pharma; Industrias Farmaceuticas Almirall S.L; LGC; marketing; MedImmune; Merck; MHRA; Mikron S A Boudry; Mikron SA Boudry; MITSUBISHI GAS CHEMICAL COMPANY, INC; Mitsui Chemicals GmbH; Mitsui Chemicals, Inc.; Nelson Labs NV; Nemera; Nipro Europe NV; Novartis; Novartis A G; Novartis International AG; Novo Nordisk A/S; Owen Mumford; Owen Mumford Ltd; Panasonic Healthcare Co., Ltd.; ProQR Therapeutics; Richter Gedeon Plc; Roche; Roche Holding; Roechling; Safepoint; Sanofi; SCHOTT Pharmceutical Systems; SCHOTT Schweiz AG; Sio2 Medical Products; Swiss Fillow AU; Terumo Europe; Terumo Europe NV; Teva Pharmaceuticals; Teva Pharmaceuticals USA; Ultrapolymers; Vetter Pharma International GmbH; Vetter Pharma-Fertigung GmbH & Co. KG; W.L. Gore & Associates, Inc.; Zeon Europe GmbH; ZwickRoell Ltd;

Workshop programme

13:00 Registration & Coffee

13:30 Scaling HFE - Doing More with Less

  • Regulatory imperative and focus on safety
  • Time and cost tradeoffs in iterative design
  • Can you be a biosimilar or generic?
  • Making changes after a Validation
     

     

  • Patricia Anderson

    Patricia Anderson, Senior Associate, Core Human Factors, Inc
    View Bio

    Marc Egeth

    Marc Egeth, Senior Director, Core Human Factors, Inc
    View Bio

    14:10 Human Factors Protocols that Work

  • Valid assessments of risks
  • Non-biasing study designs and interview techniques
  • Pivoting from a pilot
  • Pre-submission process
  • Patricia Anderson

    Patricia Anderson, Senior Associate, Core Human Factors, Inc
    View Bio

    Marc Egeth

    Marc Egeth, Senior Director, Core Human Factors, Inc
    View Bio

    14:50 Afternoon Tea

    15:20 Instructions for Use, a Human Factors Perspective

  • Why IFUs should be considered early and often 
  • Initial design
  • Iterative development
  • The good, the bad, and the ugly
  • Patricia Anderson

    Patricia Anderson, Senior Associate, Core Human Factors, Inc
    View Bio

    Marc Egeth

    Marc Egeth, Senior Director, Core Human Factors, Inc
    View Bio

    16:00 Case Studies

  • Case study #1 
  • Case study #2
  • Case study #3
  • Case study #4
     
  • Patricia Anderson

    Patricia Anderson, Senior Associate, Core Human Factors, Inc
    View Bio

    Marc Egeth

    Marc Egeth, Senior Director, Core Human Factors, Inc
    View Bio

    16:40 Session Recap

    Patricia Anderson

    Patricia Anderson, Senior Associate, Core Human Factors, Inc
    View Bio

    Marc Egeth

    Marc Egeth, Senior Director, Core Human Factors, Inc
    View Bio

    17:00 Close of Workshop

    +

    FEATURED SPEAKERS

    Marc Egeth

    Marc Egeth

    Senior Director, Core Human Factors, Inc
    Patricia Anderson

    Patricia Anderson

    Senior Associate, Core Human Factors, Inc

    Marc Egeth

    Senior Director, Core Human Factors, Inc
    Marc Egeth

    Pati and Marc manage all aspects of human factors projects at Core Human Factors. Our experience includes hundreds of different types of medical devices and combination products. We have worked on every phase of HF work, run studies all around the world, and helped dozens of different companies manage their HF programs and navigate regulatory pathways. Part of our work includes IFU design, development and testing.

    Patricia Anderson

    Senior Associate, Core Human Factors, Inc
    Patricia Anderson

    Pati and Marc manage all aspects of human factors projects at Core Human Factors. Our experience includes hundreds of different types of medical devices and combination products. We have worked on every phase of HF work, run studies all around the world, and helped dozens of different companies manage their HF programs and navigate regulatory pathways. Part of our work includes IFU design, development and testing.

    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.
     

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    SAVE TO


    Outlook Calendar  OUTLOOK CALENDAR
    Google Calendar  GOOGLE CALENDAR
    ICal Calendar  ICAL CALENDAR
    Yahoo! Calendar  YAHOO! CALENDAR

    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

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download


    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

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.

    Thank you for visiting our event

    If you would like to receive further information about our events, please fill out the information below.

    By ticking above you are consenting to receive information by email from SMi.
    Full details of our privacy policy can be found here https://www.smi-online.co.uk/privacy-legals/privacy-policy/.
    Should you wish to update your contact preferences at any time you can contact us at data@smi-online.co.uk.
    Should you wish to be removed from any future mailing lists please click on the following link http://www.smi-online.co.uk/opt-out