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Global Collaborative Review: Understanding Overall Control Strategy and Patient Benefit-Risk
Session Chair(s)
Ciby Joseph Abraham, PhD
Senior Director and Group Manager, Project and Product Leadership
AstraZeneca, United States
The pharmaceutical industry faces challenges due to global regulations. Structured data and cloud platforms can facilitate global collaborations. Visualizing the control strategy can enhance understanding of patient benefit-risk.
Learning Objective : Understand how CMC structured data enhances collaboration between industry and health authorities via cloud-based platforms; Explore the concepts of IDMP and PQ/CMC and their roles in product quality discussions; Illustrate how an overall control strategy supports efficient product quality communication.
Speaker(s)
Panel
Vada Perkins, DrSc, MSc
Boehringer Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy
Panel
David Sidney Ross, MBA, MSc, PMP, RAC
AstraZeneca, United States
Senior Director, Regulatory Data and Submissions
Panel
Brooke Casselberry, MS, RAC
Epista Life Sciences, United States
Vice President, Advisory and Delivery
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