Uzodinma Ndibe | Director, Medical Safety Assessment Physician
Bristol Myers Squibb
Uzodinma Ndibe is Director and Medical Safety Assessment Physician at Bristol Myers Squibb, where he is recognized for advancing innovation and excellence in drug safety. With more than a decade of experience in the pharmaceutical industry, Uzodinma has developed deep expertise in pharmacovigilance, medical risk management, and the evaluation of drug safety across global patient populations. Uzodinma’s career is distinguished by his ability to integrate technology and data analytics into pharmacovigilance practices, driving improvements in signal detection, risk mitigation, and safety assessment. At Bristol Myers Squibb, he leads cross-functional teams and collaborates with stakeholders to implement forward-thinking solutions that optimize patient safety and regulatory compliance. Known for his strategic mindset and commitment to continuous improvement, Uzodinma has earned a reputation as a trusted leader in drug safety. He is passionate about fostering industry partnerships and driving performance, ensuring that safety professionals remain at the forefront of scientific and technological advancements. At the World Drug Safety Congress Americas 2025, Uzodinma will share insights on the intersection of innovation, technology, and performance in drug safety, offering valuable perspectives for safety professionals and their partners.
Appearances:
Day 1 - World Drug Safety Congress Americas 2025 @ 11:00
Presentation: Enhancing Productivity with AI: Leveraging ChatGPT for Early Development Safety Roadmap (EDSR) Authoring
The Early Development Safety Roadmap (EDSR) is a critical framework in pharmaceutical research, designed to proactively identify, assess, and manage safety risks from preclinical stages through Phase 1 and 2 clinical trials. Authoring EDSRs is challenged by fragmented data sources, evolving templates, and complex cross-functional collaboration. This presentation explores how Artificial Intelligence (AI), specifically ChatGPT, can transform EDSR creation by streamlining repetitive tasks, integrating diverse datasets, and automating initial draft generation. We highlight best practices in data preparation, prompt engineering, and quality review processes, emphasizing the collaborative role of pharmacovigilance (PV) physicians and scientists. Demonstrations showcase how ChatGPT interfaces with document management systems and literature databases, accelerating literature searches, information summarization, and reference list generation. Future directions include deeper automation via ChatGPT API and copilot solutions, enabling efficient template-based drafting and seamless PV team engagement. By leveraging AI-powered tools, organizations can improve the quality, consistency, and speed of safety assessments, supporting robust risk mitigation strategies in early drug development.
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