1、White PaperThe Future is Now:The Transformation of Regulatory Processes through AI,ML,NLP,and RPAsMICHELLE GYZEN,Senior Director,Regulatory Innovation&Technology KIRAN CHINNALLA,Director,Regulatory Innovation&Technology ANKIT TYAGI,Director,Regulatory Affairs,Labeling Operation,Regulatory Affairs&Dr

2、ug Development SolutionsTable of contentsIntroduction 1How an intelligence-based regulatory ecosystem would revolutionize 2 regulatory workflowsFour key pillars of automation in a regulatory ecosystem 4The benefits of IQVIA Regulatory Intelligence Assistant(RIA)6AI/ML-enabled regulatory workflows 8A

3、I-assisted regulatory information management systems 10Conclusion 12About IQVIA 12About the authors 13 |1Artificial intelligence(AI)and machine learning(ML)are revolutionizing regulatory activities in the biopharma industry by enabling rapid data analysis for better decision-making,automating routin

4、e tasks to reduce errors and speed up processes,ensuring real-time compliance monitoring to minimize risks,and accelerating drug discovery and development to bring lifesaving drugs to market faster and more economically.By leveraging AI,organizations can streamline their regulatory activities,enhanc

5、e resource optimization,and maintain a competitive edge in a highly regulated environment.IQVIAs mission is to empower regulatory teams with innovative solutions that simplify regulatory activities,enable well-informed decision-making,promote dynamic task management,and institutionalize knowledge.Th

6、e development of automation is a key part of this vision.Our vision encompasses four key components:Regulatory Intelligence Assistant(RIA),orchestrated regulatory workflow manager,AI-assisted regulatory information management and automated content generation.Our AI solutions are designed to revoluti