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Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course

Applying HF and usability to comply with the MDR.

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

30 Sep-1 Oct 2020

& 23-24 Feb 2021 , 25-26 Feb 2021 , 20-21 Sep 2021 , 22-23 Sep 2021

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Details

Course overview

This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device to comply with the MDR. The format for the day will be interactive with the presenter sharing his experiences as a specialist with extensive knowledge and understanding of the requirements of the MDR, IEC 62366 and FDA Human Factors Guidance. There will be questions posed for discussion and delegates will work through some of the key aspects of performing a successful human factors study.

Why you should attend

By attending this seminar you will:

  • Understand the requirements of IEC 62366 and FDA Human Factors Guidance
  • Know how to provide the regulators with specific usability data for your device
  • Understand human factors and the design process
  • Learn how to validate combination products
  • Consider human factors and risk
  • Discuss generic combination products – ANDAs and HF
  • Find out what HF data FDA require for biosimilars

Who should attend?

This event will be beneficial to those working in the following areas:
  • Engineering and device development
  • Packaging
  • Regulatory affairs
  • Quality systems
  • Quality assurance
  • Risk management
  • Marketing
  • Usability and human factors engineering

Programme

Legal and regulatory basis for HF

  • US and EU law – the place of HF
  • International usability engineering (UE) standards
  • Human Factors Guidance – FDA and MHRA
  • FDA and HF

HF and the design process

  • Design inputs – how HF can guide your combination product design
  • Design verification – examples of formative work for combination products
  • Design review – how to use the outputs from formative work to feed into design review
  • Design validation – how HF fits in the design validation work

Validation testing

  • A detailed look at validating combination products
  • Objectives, methods, analysis and reporting
  • Common problems with validation
    • and how to avoid them
  • Latest FDA views on validation data for combination products

HF and risk

  • Use-related risk analysis (URRA)
    • what it is, and how it differs from FMEAs
  • Constructing a URRA – a practical exercise for a combination product
  • Risk control measures – how to use them, document them and provide evidence that they are effective
  • Residual risk – how to do a residual risk analysis


HF and the clinical trials programme

  • How and where HF activities work in relation to clinical trials
  • Differences between HF and clinical studies
  • How to gather usability data from your clinical programme

UE process

  • A practical, hands-on UE workshop, using a real combination product as an example

Generic combination products – ANDAs and HF

  • HF requirements for ANDA submissions
  • Critical design attributes
  • The role of HF in determining substitutability
  • Threshold analyses – latest FDA requirements
  • Comparative HF studies – what they are and how to run them

Ethics and IRB

  • When is IRB/ethics approval necessary for HF studies?
  • Human subject protection during HF studies – risks and mitigations

Platform devices

  • Sampling plans – who should you recruit if you don’t know what the drug will be?
  • What HF data should you develop for your platform device?

Sharps prevention – simulated clinical use testing

  • How to satisfy the FDA guidance on simulated use of sharps prevention features

Biosimilars

  • What HF data does the FDA want for biosimilars?
  • How do FDA review the human factors data for biosimilars?

Presenter

Richard Featherstone (More...)

Richard Featherstone is Research Director, Human Factors Research & Design, Emergo by UL, and previously Managing Director of Medical Device Usability Limited, a specialist human factors consultancy that works exclusively with new and emerging medical technologies. He has been designing and conducting human factors studies for over 10 years, and his experience includes a wide range of drug delivery technologies including inhalers, auto-injectors, nasal sprays and associated devices such as tele-health systems. He and the MDU team regularly test in the US, UK, Europe and Australia and undertake formative and summative testing for some of the world’s largest pharmaceutical and medical device companies as well as small start-ups. Based in Cambridge, Richard set up and grew MDU into one of Europe’s largest specialist medical HF consultancies. Over 10 years of testing has meant that Richard has built a considerable body of knowledge of the practical aspects of designing, undertaking and reporting of both types of testing.

Book now

Book now

30 Sep-1 Oct 2020
Live webinar
30 Sep-1 Oct 2020
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 19 Aug*
Enrol now
to attend
Live webinar
23-24 Feb 2021
Live webinar
23-24 Feb 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 12 Jan 21*
Enrol now
to attend
Live webinar
25-26 Feb 2021
Face-to-face, (venue not yet confirmed)
25-26 Feb 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 14 Jan 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
20-21 Sep 2021
Face-to-face, (venue not yet confirmed)
20-21 Sep 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 9 Aug 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
22-23 Sep 2021
Live webinar
22-23 Sep 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 11 Aug 21*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • Ablynx NV
  • Alk Abello A/S
  • AOP Orphan Pharmaceuticals AG
  • APTAR FRANCE SAS
  • Bespak Europe Ltd
  • Biocompatibles UK Ltd.
  • Boehringer Ingelheim Pharma GmbH & Co. KG
  • Camurus AB
  • CSL Behring
  • Eveon SA
  • Ferrer Internacional, S.A.
  • Flextronics Design srl
  • HTL-STREFA S.A.
  • Independent
  • Indivior Plc
  • Knowledge Pool Group Ltd
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Medicines and Healthcare Regulatory Agency
  • MHRA
  • Nicovations
  • Orion Corporation Orion Pharma
  • Owen Mumford Ltd
  • Portal Instruments
  • Provensis Ltd, a BTG International Group Company
  • Savara Pharmaceuticals
  • Segulah Consulting Limited
  • Silgan Dispensing Systems
  • Vetter Pharma International GmbH
  • Worrell
  • ​ F. Hoffmann-La Roche Ltd

I am very satisfied with the course. I learnt a lot and the subject of HFE studies is much clearer to me. We were able to have very good discussions with the speaker who seemed to be very knowledgeable.

Nina Bladh, Director CMC Regulatory Affairs, Camurus AB, Oct 19

Really great overview, could be more detailed but would require more time. Richard gets an A+

Matthew Gottschalk, Director of Human Factors - Europe, Worrell, Feb 18

All good - content and instruction

Herve Pacaud, Business Development Director, Aptar France SAS, Apr 17

Very informative, clearly giving in depth and suitable info

Emily Clements, Market Research, Nemaura Pharma Ltd, Apr 17

Speaker was very responsive to specific questions, which I appreciated

Andrea Fernandes, Manager, Integrated Care Strategy, Portal Instruments, Apr 17

Very good, pace right and a good refresher

Joe Neale, Director, Technical Development, Provensis Ltd, a BTG International Group Company, Jun 16

Very good, well presented and met my expectations - adapted to non-expert

Claire Jahan, Market Intelligence, APTAR FRANCE SAS , Jun 16

The course content is very relevant for anyone who is a beginner (like myself) in HF studies, the presentation style was informal and relaxed which helped the attendees to take part and there was plenty of useful audience participation

Valerie Joynson, Senior Scientific Assessor, MHRA, Jun 16