OT

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One Billion More Heartbeats: My Journey Through Heart Transplantation
In this powerful keynote from the patient’s perspective, John shares the extraordinary journey of receiving a heart transplant at age 60-and the nearly one billion more heartbeats that symbolize a second chance at life. Blending his personal story with reflections on resilience, recovery and hope, John offers a unique and deeply human perspective on the impact of healthcare, the power of science , and the grace required to bounce back.
Submitted by Anonymous on
Transforming Pharma Manufacturing: Sanofi's Journey Towards Digital Excellence in the Pharma 4.0 Era
In this keynote presentation, Brendan O'Callaghan, Executive Vice President of Manufacturing & Supply at Sanofi, will share insights into Sanofi's modernization journey and how the company is embracing a Digital-first, Data-driven, and AI-enabled strategy in a Pharma 4.0 world. The presentation will explore how Sanofi is leveraging Digital, Data, and AI to revolutionize manufacturing processes and speed the delivery of innovative medicines and vaccines to patients.
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Facilitating Analytical Procedure Changes via ICH Q14
The ICH Q14 guideline provides a science- and risk-based approach to developing and maintaining analytical procedures, ensuring they remain fit for purpose throughout a drug’s lifecycle. However, implementing changes to analytical procedures remains complex due to regulatory variations across global markets. The adoption of ICH Q14, alongside principles from ICH Q12, offers the promise of a streamlined postapproval change management process that reduces regulatory burden while maintaining compliance.