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Session 7: Optimizing Literature Surveillance: A Critical Element in the Pharmacovigilance Arsenal
Session Chair(s)
Annette S. Williams, MBA, RPh
Vice President, Pharmacovigilance
IQVIA, United States
Literature is one of the largest sources of adverse event reporting and has historically been underserved by technology. In this session, we will provide a brief review of the literature reporting requirements (both global and local). Discuss the challenges associated with managing local literature complexities. Outline optimization initiatives underpinned by technology, including AI, to advance Literature Surveillance. The EMA’s Medical Literature Monitoring (MLM) program will be highlighted to showcase the value it offers MAH’s and it is evolving. Several case studies will be showcased to highlight how organizations have increase search accuracy, reduced duplicates, minimized administrative burden, and lowered costs.
Learning Objective : - Outline the latest requirements for managing literature surveillance both globally and locally
- Detail multiple strategies for streamlining and optimizing local literature
- Discuss the roadblocks, current operational realities, and future innovation opportunities for literature surveillance
- Identify the requirements, benefits, and upcoming enhancements to the Medical Literature Monitoring (MLM) Program
Speaker(s)
Speaker
Srikanth S, MPharm
IQVIA, India
Associate Director, Head - SARA Literature center, Life Cycle Safety
Speaker
Tom Paternoster-Howe, MSc
European Medicines Agency, Netherlands
Scientific Administrator, Data Analytics & Methods, Task Force, Healthcare Data