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Session 5 Track C: Utility of Artificial Intelligence in Pharmacovigilance
Session Chair(s)
Caroline Croteau, PhD, RPh
Country Safety Lead
Pfizer Canada Inc, Canada
Pharmaceutical companies are actively pursuing automated solutions to address the challenge of managing increasing volumes of safety-related data from multiple sources. Different Artificial Intelligence (AI) and technology tools – such as robotic process automation (RPA), and natural language processing (NLP) are being assessed and applied by different companies across the pharmacovigilance (PV) continuum. Validation of such applications remains an area of focus with interest from Regulatory Agencies worldwide. This session will provide an overview of the potential uses of AI in pharmacovigilance activities, provide concrete examples from the Pharma Industry as well as Health Canada’s view on the topic and results from a survey conducted on this subject earlier this year.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand how AI can be leveraged in pharmacovigilance and define AI, RPA, and NLP
- Outline how pharma organizations are using AI as part of PV activities, including limitations and validation
- Understand Health Canada’s regulatory perspective on applying AI to pharmacovigilance strategies
Speaker(s)
Intelligent Automation Opportunities in Pharmacovigilance – The TranCelerate Group
Claudia Schaffer, RN
EMD Serono, Germany
Sr. Director, Head Case and Vendor Management
Speaker
Oeystein Kjoersvik, MS, MSc
Merck Sharp & Dohme LLC, Czech Republic
Technology Auditor and Quality Projects Lead
Embrace Automation in Pharmacovigilance – COVID-19 Vaccine Experience
Bhavin Patel, PharmD, RPh
Pfizer Inc., United States
Senior Director, Drug Safety
Applied Data Science in Modern Pharmacovigilance
John Reinhard Pietzsch, DrSc
Bayer AG, Germany
Head of PV Data Science & Insight Generation
Health Canada Regulatory Perspective and Industry Survey
Marc-André Giguère
Health Canada, Canada
Senior Policy Analyst
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