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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 Miller, JD
Acting Global Lead, Global Regulatory Policy and Intelligence
Merck & Co., Inc., 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
Karen Hicks, MD, FACC
FDA, United States
Deputy Director, Office of Medical Policy, CDER
Health Canada Update
Alysha Croker, PhD
Health Canada, Canada
Director, Centre for Policy, Pediatrics and International Collaboration, BRDD
Patient Update
Loriana Hernandez-Aldama
Armorup For Life, United States
Patient Advocate|2x Survivor| Founder, ArmorUp for Life
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