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SMi’s 4th Annual Conference
Injectable Drug Delivery
11 - 12 May, 2022 | London, UK
Workshops: 10 May 2022 | London, UK
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As Part of Europe’s leading Injectable conference series, we will assess innovations in drug product formulation and biologics, new technologies in device design and the use of long-release injectable compounds.


There is a rising demand for vaccines, insulin, and many modern medicines used to treat cancer and other chronic diseases. As biologics are mainly administered through the injectable route, the significant growth in the biologics market is expected to drive the injectable drug delivery and prefilled syringe market in the coming years. The injectable drug delivery market is expected to rise at a compound annual growth rate of 12.9% reaching £915 billion by 2027.

 

In this workshop we will present an overview of the concepts behind human factors for medical devices and combination products giving you the information you need to read and understand human factors guidances and standards. We will walk you through how we apply these concepts when analyzing a new product and designing a human factors study and how we guide our clients to evaluate the results of their human factors studies. Finally, we will share tips and tricks for instructional design.

 

This workshop will address the concepts behind designing a human factors program and human factors studies in particular with additional information about instructions for use considerations. We will cover:

  • Human Factors study designs
  • Training methodologies
  • Use-related risk analyses
  • Instructions for use design
  • 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:
 

Advanz Pharma; Amgen; AstraZeneca; BD - Becton Dickinson; Bd Medical-Pharmaceutical Systems; BD Technologies and Innovation; Becton Dickinson; Boehringer Ingelheim GmbH & Co. KG; Boehringer Ingelheim Pharma GmbH & Co. KG; BSI Group; Chugai Pharmaceutical CO. LTD.; Congenius; Core Human Factors; F Hoffmann -La Roche Inc; GlaxoSmithKline; Glenmark Pharmaceuticals Inc.; GSK; Haselmeierá; Haughton Design Ltd; Ipsen Biopharm Limited; Janssen Pharmaceutica; Janssen Pharmaceutica NV; Legacy Allergan/AbbVie; LEO Pharma A/S; MedinCell; Merck; Merck Connected Health & Devices; MHRA; Micropore Technologies Ltd; Novartis / DD&C; Novartis International AG; Novo Nordisk Pharma; Owen Mumford; Pfizer UK Limited; Raumedic AG; Roche; SABIC; Sabic SHPP; Sandoz – A Novartis Company; Sanofi; Sanofi SWI; Team Consulting; Teva Pharamceuticals; UCB; Vetter Pharma-Fertigung GmbH & Co. KG; Zealand Pharma A/S;
 

Workshop programme

8:30 Registration & Coffee

9:00 Opening Remarks

Rebecca Moses

Rebecca Moses, Principal Director, Core Human Factors Inc.
View Bio

Kim Alexander

Kim Alexander, Principal Associate, Core Human Factors
View Bio

9:10 Introduction to Human Factors

  • Where does HF fit into your project? When is it needed?
  • Who, what, where? - Your users, uses, use environments
  • Basics of different study types (formative vs. summative) and the iterative design process
  • Understanding tasks and assessments in an HF study
  • Rebecca Moses

    Rebecca Moses, Principal Director, Core Human Factors Inc.
    View Bio

    Kim Alexander

    Kim Alexander, Principal Associate, Core Human Factors
    View Bio

    9:50 Training and Memory Decay

  • A guide to when and how to include training in HF studies
  • Choosing the right memory decay period
  • Examples of training programs: different models pros and cons
  • Rebecca Moses

    Rebecca Moses, Principal Director, Core Human Factors Inc.
    View Bio

    Kim Alexander

    Kim Alexander, Principal Associate, Core Human Factors
    View Bio

    10:30 Morning Coffee

    11:00 Risk Analysis

  • Developing a robust use-related risk analysis to form the backbone of your human factors validation
  • Identifying critical tasks and success criteria
  • Design validation vs. Human Factors Validation
  • “Did we pass”? - Analyzing the results of your Human Factors Validation
  • Rebecca Moses

    Rebecca Moses, Principal Director, Core Human Factors Inc.
    View Bio

    Kim Alexander

    Kim Alexander, Principal Associate, Core Human Factors
    View Bio

    11:40 Instructions for Use

  • Overview of regulatory guidances relevant for instruction for use design
  • Focus on instructions for home use devices
  • Instructions for use design considerations (folding patterns, developing content and images, what information to include in which sections)
  • Rebecca Moses

    Rebecca Moses, Principal Director, Core Human Factors Inc.
    View Bio

    Kim Alexander

    Kim Alexander, Principal Associate, Core Human Factors
    View Bio

    12:20 Closing Remarks

    Rebecca Moses

    Rebecca Moses, Principal Director, Core Human Factors Inc.
    View Bio

    Kim Alexander

    Kim Alexander, Principal Associate, Core Human Factors
    View Bio

    12:30 End of Workshop

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    FEATURED SPEAKERS

    Kim Alexander

    Kim Alexander

    Principal Associate, Core Human Factors
    Rebecca Moses

    Rebecca Moses

    Principal Director, Core Human Factors Inc.

    Kim Alexander

    Principal Associate, Core Human Factors
    Kim Alexander

    Kimberley Alexander is a principal associate at Core Human Factors working remotely from Scotland. Prior to joining Core HF she worked in the medical device industry for many years in various areas including Human Factors, Design Quality and Research and Development. Kimberley is passionate about usability, human centered design and how users approach products. Kimberley applies this passion to human factors research endeavouring to improve medical devices through Human Factors.

    Rebecca Moses

    Principal Director, Core Human Factors Inc.
    Rebecca Moses

    Becky Moses is a Principal Director at Core Human Factors’ Israel office. She assists clients all over the world with their human factors needs for medical devices and combination products and has over 10 years of experience in the field. She frequently consults on HF regulatory strategy and has lectured at conferences across Israel and in Europe. Becky loves the work she does at Core because she has the opportunity to take a deep dive into a variety of medical technologies.

    VENUE

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    London, United Kingdom

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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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