Episode description

This presentation and panel was recorded 8 August 2024. We encourage you to download Michelle Tarver's presentation slides by ⁠⁠⁠⁠⁠completing the form on this page⁠⁠⁠⁠⁠. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the ⁠⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠⁠ ⁠⁠at RQMplus.com.

Thank you for tuning in. 🙏

RQM+ welcomes Michelle Tarver, M.D., Ph.D., Acting CDRH Director and Deputy Center Director for Transformation, FDA, CDRH, to a presentation and panel discussion aimed at increasing awareness and understanding of equity in the medical device and IVD space.

Objectives:

1. Regulatory Expectations
   Examining health equity concerns, regulatory efforts to promote equity, and FDA requirements for enhancing diversity in clinical trials
   
2. Healthcare at Home
   Exploring the "Home as a Healthcare Hub" initiative and its implications for health equity, including the challenges and opportunities of integrating healthcare services at home
   
3. Industry Perspectives
   Providing insights from industry leaders on how medical device companies are addressing health equity, with a focus on real-world examples and action plans
   
4. Action Plans and Strategies
   Sharing best practices for developing and implementing plans that assess diversity, explore risks, and identify actions to address health equity within medical device companies
   
5. Interactive Q&A
   Offering an opportunity for participants to engage with experts, ask questions, and gain a deeper understanding of the topic

Panelists:

• Michelle Tarver, M.D., Ph.D. – Acting Director and Deputy Center Director for Transformation, FDA, CDRH
• Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovations, RQM+
• Jon Gimbel, Ph.D. – Vice President of Technical, RQM+
• Brandy Chittester – Senior Director, Clinical Operations, RQM+
• Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+ (moderator)

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