1、White PaperThe Future of Pharmacovigilance:Integrating AI with Drug Safety Systems ARCHANA HEGDE,Senior Director,PV Systems&Innovations,Lifecycle Safety UPDESH DOSANJH,Practice Leader,Pharmacovigilance Technology SolutionsTable of contentsIntroduction 3The current regulatory landscape 4The next gene

2、ration of PV 7The IQVIA approach 9Looking ahead 10About IQVIA 10About the authors 11 |3The use of artificial intelligence(AI)is rapidly proliferating across industries,and the pharmaceutical space is no exception.Activating AI across every stage of the drug lifecycle can yield major benefits in term

3、s of speed,efficiency,compliance,and patient outcomes.However,the relative newness of AIs widespread use gives many across the healthcare industry pause,particularly when it comes to ensuring compliance with a rapidly evolving regulatory landscape.For pharmacovigilance(PV)teams,AI may be both appeal

4、ing and daunting.On one hand,AI can be a major asset in terms of helping experts handle increasing case volume;on the other,implementing AI in PV requires strict tracking and documentation to ensure continued compliance with shifting guidelines.Regulators like the U.S.FDA have demonstrated an ongoin

5、g effort to educate themselves and provide guidelines for leveraging AI compliant with regulations,which is reflected in several initiatives by the agency to provide clarity and direction to stakeholders,including those in the PV space.To successfully integrate AI into PV systems,an organization mus

6、t align its people,technology,and processes to build streamlined workflows supported by a robust governance structure.If done successfully,these efforts will yield significant efficiencies across PV workflows.IntroductionActivating AI across every stage of the drug lifecycle can yield major benefits