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Embedding Diversity and Inclusion into Global Clinical Research: Where Have we Been and Where are we Going?
Session Chair(s)
Alexis Reisin Miller, JD
Head, Global Regulatory Policy, MSD, United States
Adequate enrollment of underrepresented groups continues to be a challenge in a complex, global regulatory and research ecosystem. Review and assess evolving expectations and processes in the US, Canada, and other regulatory systems, what has been implemented, what adjustments have been made, what has worked, and what hurdles or differences remain.
Learning Objective : Describe the background and underlying requirements to FDA’s and other health authorities’ diversity and inclusion policies and guidance; Discuss how different stakeholders have implemented and reacted to implementation of new and evolving policies; Identify areas where views or expectations diverge; Discuss and describe what has worked, what has not; Identify how this area might change in future.
Speaker(s)
FDA Update
Deputy Director, Office of Medical Policy, CDER, FDA, United States
Health Canada Update
Director, Strategic and Horizontal Policy, Health Canada, Canada
Patient Update
Patient Advocate|2x Survivor| Founder, ArmorUp for Life, Armorup Media, United States
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