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2-Day Workshop: Human Factors & Usability Engineering in the Development of Drug Delivery Products (London, United Kingdom - February 12-13, 2019) - ResearchAndMarkets.com

November 30, 2018

DUBLIN--(BUSINESS WIRE)--Nov 30, 2018--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.

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

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/research/9xnqfl/2day_workshop?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20181130005290/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Related Topics:Drug Delivery,Drug Discovery

KEYWORD: UNITED KINGDOM EUROPE

INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS PHARMACEUTICAL

SOURCE: Research and Markets

Copyright Business Wire 2018.

PUB: 11/30/2018 10:12 AM/DISC: 11/30/2018 10:12 AM

http://www.businesswire.com/news/home/20181130005290/en

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