The "Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course 24" 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.

Benefits of attending

• 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
• Packaging
• Regulatory affairs
• Quality systems
• Quality assurance
• Risk management
• Marketing
• Usability and human factors engineering

Key Topics Covered:

Introduction

• Scope of the training
• Expectations for the training

Background to human factors

• Human factors, usability and ergonomics defined
• Trends in drug delivery device technology
• Use errors - scale, scope and implications
• Defining the user interface
• Usability research, clinical research and market research compared

Legal and regulatory requirements

• US law and design control - implications for HF
• MDR and usability requirements
• Article 117 and implications for combination products
• UK medical device regulations

IEC62366, FDA guidance and expectations

• IEC62366 usability engineering process
• FDA human factors guidance
• ISO14971 applied to combination products
• EMA guidance on combination products
• Chinese human factors guidance 2022

Human factors methods and best practices

• Human factors engineering
• Perception, cognition and action model
• Heuristic analysis

Design control, design and development

• Design and development planning
• Role of human factors in design control
• UE methods and outputs
• UE integration with combination product development

User needs & user interface specifications

• Regulatory requirements for user needs
• Defining formal user needs
• User requirements and the design trace matrix
• Building a user interface specification

Formative and validation testing methods

• Formative testing methods
• Human factors validation methods

Use-related risk

• Regulatory requirements for use-related risk
• ISO14971 applied to combination products
• Risk analysis methods
• Risk control
• Residual risk analysis

HF and clinical trials

• How HF and clinical trials differ
• How to gather HF data during clinical trials
• Changing the user interface during the trial program
• HF requirements for INDs and IDEs

Technical data requirements

• HF contents of a design history file
• HF contents of a EU technical file

Predicate devices, platform devices and post-market surveillance

• Platform devices - how to incorporate HF
• Platform device due diligence
• Post-market HF requirements - US and EU

Generic devices, biosimilars and ANDAs

• How to do a database and literature search for known use problems
• ANDA submissions and HF
• ANDA versus 505(b)(2) HF requirements
• FDA HF requirements for biosimilars

Practicalities - how to stay legal

• GDPR, IRB, HIPAA and the Sunshine Act
• When to apply for ethics/IRB approval
• Common GDPR problems during HF testing

Wrap-up

• Common pitfalls and top tips
• Top tips

Speakers:

Richard Featherstone

Human Factors Director

Medical Device Usability Limited

Richard Featherstone is Human Factors Director of 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 associated devices such as tele-health systems. 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 small start-ups.

Based in Cambridge, MDU has grown rapidly to become Europe's largest specialist medical HF consultancy with clients around the world. Over 10 years of testing has meant that Richard has built a considerable body of knowledge of the practical aspects of designing, undertaking and reporting of both types of testing.

For more information about this conference visit https://www.researchandmarkets.com/r/old29p

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