This workshop will aim to provide you with a holistic view and help you prepare for product review, to ensure a smooth approval process for timely launch in market.
You will learn about:
1. The FDA regulation for combination products comprised of any combination of a drug and a device; a device and a biological product; a biological product and a drug; or a drug, a device, and a biological product. A combination product remains subject to the regulatory requirements associated with its constituent parts. Our focus will be on the Single Entity combination products for pre-filled syringes or injection devices.
2. The streamlined CGMP approach for drug product and delivery devices. The importance of human factor studies to evaluate the user interface of a product is required. The impact of the quality of primary container/closure systems to the success of the combination products will be discussed.
3. The different approaches of EMA and MHRA regulations on
pre-filled syringes and injection devices.
4. The global technical and quality requirements for pre-filled
syringes and injection devices.
This hands-on workshop offers a deep dive exploring how to bring a safe and usable medical product to market. Combining presentations, multimedia and hands-on activities, participants will gain a sense of what it means to develop products with user foremost in mind.
This workshop will outline:
• The application of FMEAs and human factors in risk management
• What is use-related risk analysis and how does it guide design decisions relating to safety?
• Acceptance criteria for usability validation study
• Compliance documentation and international regulation related to use-related risk management
Join this workshop to address your critical questions, including:
• What do I need to know about Use-Related Risk Analysis as an R&D Engineer, Marketing specialist, complaints manager, or quality engineer?
• What is the difference between “normal use” and “abnormal use”?
• Why do we exclude “abnormal use” from a Use-Related Risk Analysis?
• How do I know when a Use-Related Risk Analysis is “complete” and has captured all use-related risks?
• Why does the FDA recommend conducting a Task Analysis and how do I create one?
• How do I write and trace mitigations in a Use-Related Risk Analysis?
Since the inception of HE75 and the more recent Human Factors Final Guidance, human factors is no longer a ‘nice to have’ but necessity for a number of combination devices submissions.
However, companies still struggle with understanding and navigating the expectations of the FDA. A more recent draft guidance (Comparative Analyses & Related Comparative Use Human Factors Studies for a Drug-Device Combination Product) has also resulted in increased grey areas around expectations.
The first focus of this workshop is to better understand your device (and its features) from an HF perspective.
1. Pitfalls of common PFS and AI designs
2. Features to consider even when procuring off the shelf- solutions
3. When to consider labeling and packaging (it may be sooner than you think)
Another focus of this of this workshop is to understand how to design human factors studies. Not all studies are created equally but there are basic expectations that should be met.
1. Who should you test? Who are your “unique” user groups?
2. What should you test? What should be considered?
3. When should you test?
4. Where should you test?
A third focus of this workshop is to spend time discussing other pertinent device scenarios.
1. What if the device has been on the market for 20+ years?
2. What if the device is a generic?
3. What if studies have been conducted in another country?
4. What if data has been collected in clinical trials similar to human factors data?