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Session 3, Tracks A, B, C: Integrating Equity, Diversity and Inclusion Across the Drug Product Lifecycle
Session Chair(s)
My (may) Dang, MBA
Director, Regulatory Affairs, Cencora, Canada
Melanie Cote, MS
Senior Manager, Global Regulatory Affairs, Otsuka Pharmaceutical Development & Commercialization Inc., Canada
Speakers in this session will provide an update on the efforts under way to promote diversity, equity and inclusion in clinical trials in Canada. Health Canada will outline its Sex and Gender Based Analysis Plus (SGBA Plus) Action Plan, including its regulatory proposal on disaggregated data. Attendees can expect to gain a better understanding of how government, industry and patients are supporting the creation of more equitable drug development and regulatory systems.
Learning Objective : - Understand the importance of developing a more equitable drug development/ regulatory system, as well as the current challenges and barriers
- Describe current efforts to increase equitable drug development and regulatory systems
- Identify challenges and complexities in collecting and assessing disaggregated data
Speaker(s)
Roberta Albany
Founder/CEO, Cancer In The Know, United States
Speaker
Alysha Croker, PHD
Director, Strategic and Horizontal Policy, Health Canada, Canada
Health Canada’s Sex and Gender-Based Analysis (SGBA) Plus Action Plan
Vanessa Cahee
Clinical Operations & Clinical Trial Diversity Consultant, VCahee Consulting LLC, United States
Recent Clinical Trial Diversity Guidance in the United States
Ambily Banerjee, PHD
Senior Director/Head of Diversity in Clinical Trials, Johnson and Johnson Innovative Medicine, United Kingdom
Inclusive Clinical Studies – for Equitable Access to clinical reSearch in Europe (EASE)