Action Steps for FDA Diversity Action Plans
Simply developing a Diversity Action Plan to meet the US Food and Drug Administration (FDA) updated guidance is not enough.
Date: September 25, 2024
Time: 12:00 – 1:00 PM ET
Sponsors must demonstrate intent: That is, action plans must be both operational and executable. What’s more, the FDA is scrutinizing the quality of the data supporting these action plans. In this live webinar, industry experts will offer examples of how diversity action plans vary among therapeutic areas — and why one size does not fit all. They also will explain why it’s important to incorporate action plans earlier in the clinical trial process, as well as consequences for failing to follow a submitted plan. The discussion will include a deep dive into the FDA regulatory guidance:
- What studies are required to develop Diversity Action Plans
- What components must be included in each plan
- Enrollment goals for racial, ethnicity, sex, and age groups (including rationale for and measures to meet goals)
- When plans must be submitted to the FDA
- How to submit plans and receive feedback
Speakers:
Brad Davis
Principal
Norstella
Brad Davis is a principal at Norstella with a depth of experience deriving actionable insights from real-world data (RWD). Brad has been in the pharmaceutical industry for 20+ years spanning clinical development, management consulting, and communications. This unique blend of clinical and commercial expertise including clinical trial strategy and design, patient recruitment, portfolio optimization, and commercial launch strategy allows for an innovative approach to problem solving. He has significant experience across therapeutic areas, particularly psychiatry, neurology, oncology, immunology, and rare diseases.
Fenwick Eckhardt
Head of Diversity Strategy
Citeline
Fenwick Eckhardt is head of diversity strategy at Citeline. She is dedicated to revolutionizing the life sciences industry through cutting-edge solutions that harness real-world data, technology, and analytics. With over five years of experience in pharma and biotech, Fenwick excels in optimizing clinical trial design and outcomes to expedite the delivery of life-saving therapies. She holds a master’s degree from Imperial College London and a bachelor’s in human physiology from Boston University.
This program is sponsored by Citeline.
Note: This free session does not provide ACRP Contact Hours.