2025年制药和生物技术安全和监管合规趋势及预测

White Paper 2025 Safety andRegulatory ComplianceTrends and Predictionsfor Pharma and Biotech PATRICK BRADY, Global Head, Therapeutic Innovation & Regulatory ScienceMARCELA MIÑO, Global Head, Lifecycle Management & Regulatory AffairsSIMON JOHNS, Director, Medical Information & Marketed Product SafetySABIKA RIZVI, Director, Aggregate Reporting & Benefit Risk Management ServicesANA PEDRO JESUÍNO, Associate Director, Marketed Product Safety Table of contents Introduction1What 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.3What role do you see AI playing in 2025?Taking into consideration how new technologies and AI are improving lifecycle4management processes, how does it specifically affect the preparation and submissionof chemistry, manufacturing, and controls (CMC) variations?How do you see global regulatory bodies moving toward harmonization of submission5processes in 2025? What impact could this have on accelerating approvalsin emerging markets?How can pharmaceutical companies better adapt their operations to meet evolving5local regulatory requirements? What role will a local Qualified Person forPharmacovigilance (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,6specifically for MI management? What challenges may arise in maintaining complianceacross AI-driven platforms, call centers, and digital channels?On the post-approval side of things, how do you see AI and data analytics enhancing7post-approval lifecycle management activities like registration renewals and labelupdates 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 of8organizations that choose partners to relieve that burden. How do you see thatbeing delivered in 2025?About IQVIA8About the authors9 Introduction As the landscape for drug safety and regulatorycompliance continues to evolve to accommodate morecomplex therapies, drug sponsors are considering howto handle increasing global demand, shifting patientneeds, and a boon of new technologies, includingartificial intelligence (AI). While navigating theseconcurrent shifts can be overwhelming in the shortterm, in the long term, improved technology integrationwill help produce more patient-centric solutions andaccommodate growing patient and healthcare providerinquiries. As you review your current approaches,consider where innovation might ease resource strainand enhance existing workflows. In a recent webinar hosted by IQVIA, a panel ofexperts spoke to the latest developments acrosspharmacovigilance (PV), Medical Information (MI),and lifecycle management (LCM). Read their safety,regulatory, and technology predictions for 2025in this White Paper. In the long term, improved technologyintegration will help produce morepatient-centric solutions “Bringing technology into the field ofPV helped integrate real-world data,ensure greater accuracy, and set aprecedent for how technologies canbe harnessed more broadly across thepharmaceutical industry to addresscomplex changes.” What developments in yourarea of expertise surprisedyou the most in 2024? SABIKA RIZVI:2024 has been extremely eventful fordrug safety services, especially niche safety serviceslike periodic report writing, literature, and statementmanagement services. We observed a surprisingsearch for local affiliate service requests for thisgroup, especially in local literature surveillance, localperiodic report writing, and local risk management.Historically, the outsourcing of these types of activitieshas been limited considering the complex nature of thiswork. However, with high-cost pressures and globalmicroeconomic conditions, sponsors are now lookingfor a more cost-efficient solution to manage regionalPV services with elevated quality and compliance. — Pedro Jesuíno complex changes. We now have a better understandingof the data we are receiving, and we can collect andanalyze more information more rapidly. PATRICK BRADY:In 2024, the FDA held publicworkshops with different stakeholder groups aroundclinical trial innovation. They started the CDER Centerfor Clinical Trial Innovation (C3TI) and released draftguidance on master protocols for product development.One of the things that the EMA is doing to encourageclinical trial innovation is the Accelerating Clinical Trialsin the European Union (ACT EU) initiative. There hasbeen a lot of stakeholder engagement there, and theEMA has shown leadership in determining, what do weneed to do to make Europe an attractive environmentfor conducting clinical research? It is encouraging to seehow regulators across different jurisdictions are takingsteps to attract clinical research. For these niche gr