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Wednesday, June 17 • 2:00pm - 3:00pm
#330 L: Application and Validation of Intelligent Automation Technology in PV: Exploring Opportunities within the Individual ICSR Process

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-692-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Neal Grabowski, MBA, MS

Speaker

Case Study
Kate Gofman, MD, PhD

Case Study
Oeystein Kjoersvik, MSc


Speakers
avatar for Kate Gofman

Kate Gofman

Safety Physician, Astrazeneca
Kate Gofman, MD, Ph.D., is currently working as a Global Patient Safety Physician at AstraZeneca. She has been with AstraZeneca for more than five years delivering global safety strategy and oversight for various compounds. Kate serves as an industry expert for automation & digital... Read More →
KG

Kate Gofman

Global Safety Physician, AstraZeneca
Kate Gofman, MD, Ph.D., is currently working as a Global Patient Safety Physician at AstraZeneca. She has been with AstraZeneca for more than five years delivering global safety strategy and oversight for various compounds. Kate serves as an industry expert for automation & digital... Read More →
NG

Neal Grabowski

Director, Pharmacovigilance & Patient Safety, AbbVie, United States
Prior to joining AbbVie, Neal held multiple roles in Patient Safety and Clinical Operations at Amgen, Genzyme and Sanofi. He holds a MS in biomedical engineering and MBA from Pepperdine University.
avatar for Oeystein Kjoersvik

Oeystein Kjoersvik

Product Owner/Business Analyst, Merck & Co., Inc., Czech Republic
Oeystein Kjoersvik is currently a Product Owner/Business Analyst at MSD, functioning as a squad lead for an analytics group supporting QA through utilizing data science and other analytics tools. Oeystein also serves as a Machine Learning SME for TransCelerate's Intelligent Automation... Read More →

Wednesday June 17, 2020 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session