DUBLIN–(BUSINESS WIRE)–July 26, 2022–
The lecture “Human Factors and Usability Engineering in Drug Delivery Product Development Training Course” has been added to the ResearchAndMarkets.com offering.
This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development or who need to provide regulators with specific usability data to have their device MDR compliant.
The day’s format will be interactive, with the presenter sharing his experiences as a specialist with in-depth knowledge and understanding of the requirements of MDR, IEC 62366 and FDA human factors guidelines. There will be questions posed for discussion and delegates will work through some of the key aspects of conducting a successful human factors study.
Why should you attend
- Understand the requirements of IEC 62366 and FDA Human Factors Guidelines
- Know how to provide 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 risks
- Discuss Generic Combination Products – ANDA and HF
- Discover the HF data required by the FDA for biosimilars
Who should attend:
This event will benefit those working in the following areas:
- Device engineering and development
- Regulatory Affairs
- Quality systems
- Quality assurance
- Risk management
- Usability and human factors engineering
Main topics covered:
Legal and regulatory basis for HF
- American and European legislation – the place of HF
- International Usability Engineering Standards (EU)
- Human Factors Guidelines – FDA and MHRA
- FDA and HF
HF and the design process
- Design inputs – how HF can guide your combo product design
- Design verification – formative working examples for combination products
- Design review – how to use the results of the formative work to feed into the design review
- Design validation – how HF fits into design validation work
- A detailed overview of the validation of combined products
- Objectives, methods, analysis and reporting
- Common validation issues
- Latest FDA Notices on Combination Product Validation Data
HF and risk
- Use Risk Analysis (URRA)
- What it is and how it differs from FMEAs
- Building an URRA – a practical exercise for a combination product
- Risk control measures – how to use them, document them and prove that they are effective
- Residual risk – how to do a residual risk analysis
HF and the clinical trial program
- How and where HF activities work in relation to clinical trials
- Differences between IC and clinical studies
- How to collect usability data from your clinical program
- A hands-on, hands-on EU workshop, using a real combo product as an example
Generic Combination Products – ANDA and HF
- HF Requirements for ANDA Submissions
- Critical design attributes
- The role of HF in determining substitutability
- Threshold analyzes – latest FDA requirements
- Comparative HF studies – what they are and how to perform them
Ethics and IRB
- When is IRB/ethical approval required for HF studies?
- Protection of human subjects during HF studies – risks and mitigations
- Sampling plans – who should you recruit if you don’t know what the drug will be?
- What HF data should you develop for your rig device?
Sharps prevention – simulated clinical use tests
- How to Meet FDA Guidelines for Simulated Use of Sharps Prevention Features
- What HF data does the FDA want for biosimilars?
- How does the FDA review human factors data for biosimilars?
Human Factors Director
Limited use of medical devices
Richard Featherstone is Director of Human Factors at 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 related devices such as of telehealth. 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 smaller start-ups. -ups.
Based in Cambridge, MDU has grown rapidly to become Europe’s largest specialist HF medical consultancy with clients around the world. Over 10 years of testing has provided Richard with a considerable body of knowledge on the practical aspects of designing, performing and reporting both types of tests.
For more information on this conference, visit https://www.researchandmarkets.com/r/373or2
See the source version on businesswire.com: https://www.businesswire.com/news/home/20220726005823/en/
Laura Wood, Senior Press Officer
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INDUSTRY KEYWORD: HEALTH PHARMACEUTICALS
SOURCE: Research and Markets
Copyright BusinessWire 2022.
PUBLISHED: 07/26/2022 11:42 a.m. / DISK: 07/26/2022 11:42 a.m.
Copyright BusinessWire 2022.