Back to Agenda
Application and Validation of Intelligent Automation Technology in PV: Exploring Opportunities within the Individual ICSR Process
Session Chair(s)
Neal Grabowski, MBA, MS
TransCelerate IAO Workstream Lead; Head, Signal Management
Sanofi, United States
This session will discuss a validation framework that extends existing guidance, incorporates best practices from other industries and member companies, and promotes discussion of key considerations to achieve early alignment on validation requirements in advance of future guidance. The ICSR processing workflow is the use case for evaluating intelligent automation opportunities due to its logical progression of process steps, highly manual nature, high volume, and inherent quality risks of errors and operational inefficiencies.
Learning Objective : Describe the current technology landscape in PV, particularly focusing on the ICSR process; Discuss intelligent automation opportunities within the ICSR process using an industry survey results and online ICSR process map; Identify considerations for validating intelligent automation technologies in pharmacovigilance to promote inspection readiness and inform third party development.
Speaker(s)
Case Study
Kate Gofman, MD, PhD
BioNTech US, United States
Senior Director, Safety Strategy Lead
Case Study
Oeystein Kjoersvik, MS, MSc
Merck Sharp & Dohme LLC, Czech Republic
Technology Auditor and Quality Projects Lead
Have an account?