Dublin, Aug. 04, 2021 (GLOBE NEWSWIRE) -- The "Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course" conference has been added to ResearchAndMarkets.com's offering.
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.
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
Usability and human factors engineering
Key Topics Covered:
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
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
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
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
What HF data does the FDA want for biosimilars?
How do FDA review the human factors data for biosimilars?
For more information about this conference visit https://www.researchandmarkets.com/r/jhwy8p
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