艾昆纬-2025年制药和生物技术安全和监管合规趋势及预测（英）

White Paper2025 Safety and Regulatory Compliance Trends and Predictions for Pharma and Biotech PATRICK BRADY, Global Head, Therapeutic Innovation & Regulatory ScienceMARCELA MIÑO, Global Head, Lifecycle Management & Regulatory Affairs SIMON JOHNS, Director, Medical Information & Marketed Product SafetySABIKA RIZVI, Director, Aggregate Reporting & Benefit Risk Management ServicesANA PEDRO JESUÍNO, Associate Director, Marketed Product SafetyTable of contentsIntroduction 1What developments in your area of expertise surprised you the most in 2024? 2Speaking of innovation, it’s clear that GenAI is one of the hottest topics in this space. 3 What role do you see AI playing in 2025?Taking into consideration how new technologies and AI are improving lifecycle 4 management processes, how does it specifically affect the preparation and submission of chemistry, manufacturing, and controls (CMC) variations? How do you see global regulatory bodies moving toward harmonization of submission 5 processes in 2025? What impact could this have on accelerating approvals in emerging markets?How can pharmaceutical companies better adapt their operations to meet evolving 5 local regulatory requirements? What role will a local Qualified Person for Pharmacovigilance (QPPV) play in ensuring compliance across different regions? What technological innovations are you using to enhance cross-team collaborations? 6How do you envision pharmaceutical companies leveraging omnichannel systems, 6 specifically for MI management? What challenges may arise in maintaining compliance across AI-driven platforms, call centers, and digital channels?On the post-approval side of things, how do you see AI and data analytics enhancing 7 post-approval lifecycle management activities like registration renewals and label updates in 2025?Do you see regulatory bodies placing stricter guidelines on the use of AI in 2025? 7Keeping up with regulatory guidance is difficult. Over time, we’ve seen a lot of 8 organizations that choose partners to relieve that burden. How do you see that being delivered in 2025? About IQVIA 8About the authors 9 iqvia.com | 1As the landscape for drug safety and regulatory compliance continues to evolve to accommodate more complex therapies, drug sponsors are considering how to handle increasing global demand, shifting patient needs, and a boon of new technologies, including artificial intelligence (AI). While navigating these concurrent shifts can be overwhelming in the short term, in the long term, improved technology integration will help produce more patient-centric solutions and accommodate growing patient and healthcare provider inquiries. As you review your current approaches, consider where innovation might ease resource strain and enhance existing workflows. In a recent webinar hosted by IQVIA, a panel of experts spoke to the latest developments across pharmacovigilance (PV), Medical Information (MI), and lifecycle management (LCM). Read their