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Human Factors and Usability Engineering in the Development of Drug Delivery Products
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.
Introduction
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
- Engineering and device development
- Packaging
- Regulatory affairs
- Quality systems
- Quality assurance
- Risk management
- Marketing
- Usability and human factors engineering
Programme day one
Legal and regulatory basis for human factors
- US and EU law – the place of human factors
- International usability engineering (UE) standards
- Human Factors Guidance – FDA and MHRA
- FDA and human factors
Human factors 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 human factors 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
Human factors 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
Programme day two
Human factors 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
Usability engineering process
- A practical, hands-on UE workshop, using a real combination product as an example
Generic combination products – ANDAs and HF
- Human factors 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?
Book now
| 30 Sep-1 Oct 2020 | |||
| 30 Sep-1 Oct 2020 | Rembrandt Hotel, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
Enrol now |
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Previous customers include...
- Ablynx NV
- AOP Orphan Pharmaceuticals AG
- APTAR FRANCE SAS
- Bespak Europe Ltd
- Biocompatibles UK Ltd.
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Camurus AB
- CSL Behring
- DCA Design International
- Eveon SA
- Ferrer Internacional, S.A.
- Flextronics Design srl
- HTL-STREFA S.A.
- Independent
- 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
- Presspart Manufacturing Limited
- Provensis Ltd, a BTG International Group Company
- Research and Markets
- Savara Pharmaceuticals
- Segulah Consulting Limited
- Silgan Dispensing Systems
- Vetter Pharma International GmbH
- Worrell
“Really great overview, could be more detailed but would require more time. Richard gets an A+”
Matthew Gottschalk, Director of Human Factors - Europe, Worrell
“All good - content and instruction ”
Herve Pacaud, Business Development Director, Aptar France SAS
“Very informative, clearly giving in depth and suitable info ”
Emily Clements, Market Research, Nemaura Pharma Ltd
“Speaker was very responsive to specific questions, which I appreciated”
Andrea Fernandes, Manager, Integrated Care Strategy, Portal Instruments
“Very good, well presented and met my expectations - adapted to non-expert”
Claire Jahan, Market Intelligence, APTAR FRANCE SAS
“Very good, pace right and a good refresher ”
Joe Neale, Director, Technical Development, Provensis Ltd, a BTG International Group Company
“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