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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

Application and Validation of Intelligent Automation Technology in PV: Exploring Opportunities within the Individual ICSR Process

Session Chair(s)

Neal  Grabowski, MBA, MS

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)

Kate  Gofman, MD, PhD

Case Study

Kate Gofman, MD, PhD

BioNTech US, United States

Senior Director, Safety Strategy Lead

Oeystein  Kjoersvik, MS, MSc

Case Study

Oeystein Kjoersvik, MS, MSc

Merck Sharp & Dohme LLC, Czech Republic

Technology Auditor and Quality Projects Lead

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