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Wednesday, June 19 • 3:15pm - 4:15pm
#365: Embedding Diversity and Inclusion into Global Clinical Research: Where Have we Been and Where are we Going?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-665-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Alexis Miller, JD

Speaker

FDA Update
Karen Hicks, DrMed

Health Canada Update
Alysha Croker, PhD

UK Update
Naho Yamazaki, PhD

Patient Update
Loriana Hernandez-Aldama


Speakers
avatar for Alexis Miller

Alexis Miller

Acting Global Lead, Global Regulatory Policy and Intelligence, Merck & Co., Inc., United States
Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping to shape the regulatory and policy environments on topics like evolution in regulatory science and policy frameworks, upholding expedited pathways, leveraging RWE and other tech opportunities, embedding... Read More →
avatar for Alysha Croker

Alysha Croker

Director, Centre for Policy, Pediatrics and International Collaboration, BRDD, Health Canada, Canada
Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric... Read More →
avatar for Loriana Hernandez-Aldama

Loriana Hernandez-Aldama

Patient Advocate|2x Survivor| Founder, ArmorUp for Life, Armorup For Life, United States
Loriana is a 2x cancer survivor, international motivational speaker, award-winning journalist, podcast host, and author of "Becoming the Story: The Power of Prehab." Bold, transparent, and honest, Loriana has emerged as a game-changer in healthcare, advocating globally for transformative... Read More →
avatar for Karen Hicks

Karen Hicks

Deputy Director, Office of Medical Policy, CDER, FDA, United States
Dr. Hicks is the Deputy Director of the Office of Medical Policy in the Center for Drug Evaluation and Research (CDER) at the United States Food and Drug Administration (FDA). She oversees regulation and policy development for CDER and participates in cross-cutting agency initiatives... Read More →
avatar for Naho Yamazaki

Naho Yamazaki

Deputy Director, Policy and Partnerships, Health Research Authority, United Kingdom
Naho is Deputy Director, Policy and Partnerships at the Health Research Authority (HRA), where she is leading on a range of policy and engagement initiatives for the HRA to make it easy to do research that people can trust. This includes pushing for change to increase diversity and... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum