Human Factors and Usability Engineering in the Development of Drug Delivery Products Workshop: Requirements of IEC 62366 and FDA Human Factors Guidelines - London, United Kingdom - October 2-3, 2019

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Sep 16, 2019, 13:45 ET

DUBLIN, Sept. 16, 2019 /PRNewswire/ -- The "Human Factors and Usability Engineering in the Development of Drug Delivery Products" 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.

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 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 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
Ensure you test the right product
Learn how to get the human factors right for combination products
Ensure you get the right study participants
Find out how to set up simulated use environments
Consider the labelling, packaging and the instructions
Discuss training strategies for your device

Who Should Attend:

This seminar 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

Agenda:

Welcome and introductions

Guidance, standards and the law - what MUST be done

Requirements of IEC 62366 and FDA Human Factors Guidance
What is the legal and regulatory status of human factors
How do the European and US requirements compare?
Which guidelines should I be following for my product?

How to provide the regulators with specific usability data for your device

What are the regulators looking for?
What are their requirements?
Successful applications - how to maximise the chance of a successful review

Starting at the right place

How and when should you start planning your human factors study?

Combination products

How and why are combination products different
How to get the Human Factors right for them
ANDAs - what human factors data do I need if I am submitting an ANDA?

How to pass the validation study

Do I need to do a validation study?
How do I know if my product will pass the validation?
How to avoid the common pitfalls in validation studies
US versus Europe - do I need to run a validation study in both locations?

Setting up a HF study - who are your users?

Key points to consider when setting up a HF study
Your intended users may not be who you think they are
How to establish the users of your product
How do you make sure you get the right study participants?

Testing the right product

How do you decide what to test?
Ensuring you avoid testing the wrong prototype or the wrong design iteration

Simulated use environments

Using higher fidelity test environments
Important environmental factors to consider

Labelling, packaging and the instructions for use

Packaging, labelling and instructions are part of the device user interface
Testing the packaging and labelling
What needs to be tested?
How to test successfully

Training considerations

Will your users be trained to use your device?
What training materials will you provide?
Is the device a home-use device, in which case do you need a no-training group?

Frequent versus worst case scenarios

Which scenarios should you include?
Do you need to test every possible scenario?

For more information about this conference visit https://www.researchandmarkets.com/r/jhr2o

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