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Thursday, June 17 • 12:00pm - 1:00pm
#509 OD: Artificial Intelligence Validation Framework: Is it New and Different?

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Component Type: Session
Level: Intermediate

How will artificial intelligence and machine learning align with the validation documentation to affirm compliance. What are risk-based approaches? What are the challenges of validating machine learning and artificial intelligence?

Learning Objectives

Recognize the definitions of artificial intelligence; Explain and apply the risk-based framework that applies to artificial intelligence; Describe challenges and potential approaches for affirming compliance.


Kristof Huysentruyt, MSc


Industry Update
Kristof Huysentruyt, MSc

Industry Update
Oeystein Kjoersvik, MSc

Industry Update
Beth Savage, BSN, MBA


Kristof Huysentruyt

Head of Safety Data PROS, UCB Pharma S.A., Belgium
Kristof is a PV professional with more than 10 years experience in pharmacovigilance. He joined UCB in 2009 and has been heading PV systems and data management. Kristof has been leading several initiatives such as the implementation of a new safety database system and several automation... Read More →

Beth Savage

Senior Director, Head of Global Case and Safety Data Management, Johnson & Johnson, United States
Beth is Head of Global Case and Safety Data Management at Janssen Research & Development, LLC a division of Johnson & Johnson. Beth has more than 25 years of global Pharmacovigilance leadership experience developing strategies, driving operational excellence, and ensuring compliance... Read More →
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 →

Thursday June 17, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Session |   01: ClinSafety-PV, Session |   20: Early Access Content, Session