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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.

Chair

Kristof Huysentruyt, MSc

Speaker

Industry Update
Kristof Huysentruyt, MSc

Industry Update
Oeystein Kjoersvik, MSc

Industry Update
Beth Savage, BSN, MBA


Speakers
KH

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 →
BS

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

Technology Auditor and Quality Projects Lead, TransCelerate, MSD, Czech Republic
Oeystein Kjoersvik is currently a Technology Auditor and Quality Projects lead at MSD, one of his focuses is AI within QA. Oeystein also serves as a Machine Learning SME for TransCelerate's Intelligent Automation team. Prior to his current role, he held the role of Product Owner and... 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