Section 3602 of the Food and Drug Omnibus Reform Act requires the Food and Drug Administration (FDA) to issue or update guidance on the format and content of diversity action plans within 12 months of its enactment—by the end of 2023. Members of the Case Western Reserve University community are invited to join the Clinical and Translational Science Collaborative (CTSC) for a workshop exploring FDA recommendations for diversity action plans—from its April 2022 draft guidance—as the university’s research community prepares to meet this requirement.
This workshop will be held Wednesday, Sept. 13, from 10 a.m. to 2 p.m. at the Warrensville Heights Branch of Cuyahoga County Public Library (4415 Northfield Road).
Attendees will hear from several speakers on different topics:
“Finding the Evidence: Disease/Condition Overview” with Susan Connor, associate director of research programs with the CTSC
“Trial Enrollment and Retention Strategies” with Kassandra Spates-Harden of the Cleveland Clinic
“Setting Enrollment Goals of Underrepresented Populations” with Yasir Tarabichi of MetroHealth
“Status of Meeting Enrollment Goals (Post-Marketing Data Collection)”
Participants will leave with a draft diversity action plan/template.