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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 : Recognize how CMC structured data enhances collaboration between industry and health authorities via cloud-based platforms; Discuss 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)
Panelist
Katie Duncan, PHD
GSK, United States
Director, CMC Policy and Advocacy
Panelist
David Ross, MBA, MSC, PMP, RAC
AstraZeneca, United States
Senior Director, Digitial Advocacy and Policy
Panelist
Vada Perkins, DRSC, MSC
Boehringer Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy
Panelist
Omar Serang
DNAnexus, United States
Chief Cloud Officer
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