[Emergo, UL] Webinar: Best Practices for Engaging with the US FDA on Human Factors Strategy

Emergo에서 아래와 같이 웨비나를 개최한다.

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▶ 주제: Best Practices for Engaging with the US FDA on Human Factors Strategy

▶ 일시: 2024년 07월 11일 EST 10시 (한국시간: 07월 11일 23시)

 

 

Engaging with the U.S. Food and Drug Administration (FDA) on your human factors engineering (HFE) strategy is an important step toward achieving a successful medical product submission and subsequent U.S. market access.

 

In this webinar, the presenters will share best practices related to engaging with the FDA regarding the HFE work planned and performed during product development. The presenters will reflect on decades of relevant experience, share case studies and present actionable advice on making FDA interactions more productive and insightful. The presenters will also share what to expect during each key phase of FDA interaction and the current topics in focus for the FDA’s HFE reviews.

 

Attendees will come away with a deepened understanding of topics including:

• Developing HFE content for pre-submissions, including a use-related risk analysis, HF validation test protocol and other required content
• Preparing for and confidently leading FDA meetings on various HFE topics
• Interpreting and responding to FDA feedback
• Refining your HFE strategy based on the feedback you receive on your pre-submission or submission

 

Best Practices for Engaging with the US FDA on Human Factors Strategy | Emergo by UL

Best Practices for Engaging with the US FDA on Human Factors Strategy

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