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Virtual

Mar 29, 2023 10:00 AM - Mar 31, 2023 4:15 PM

(US Eastern Standard Time)

DIA/FDA Biostatistics Industry and Regulator Forum

Join us virtually from the comfort of your home/office March 29-31 or watch later at a time that works for you. This event provides access to the materials for a full two months!

Session 8: Machine Learning and Safety Statistics

Session Chair(s)

Stella C. Grosser, PhD, MS

Stella C. Grosser, PhD, MS

Division Director, Office of Biostatistics, OTS, CDER

FDA, United States

Jerald  Schindler, DrPH

Jerald Schindler, DrPH

Chief Executive Officer

Strategic Statistics, United States

Machine learning methods have been used in a wide variety of fields. In this session, we will examine their use in the statistical detection and analysis of medical product safety signals. Examples will include natural language processing of patient narratives post-marketing and real-time monitoring of adverse events in clinical trials. Case studies will be presented with a panel discussion and lessons learned.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe the current use of ML in analysis of safety data by the pharmaceutical industry and regulatory agencies
  • Identify areas of potential future applications and methods development
  • Recognize advantages and pitfalls of ML in identifying safety concerns with medical products

Speaker(s)

Jae Joon  Song, PhD

Speaker

Jae Joon Song, PhD

Food and Drug Administration, United States

Mathematical Statistician

Melvin Slaighter Munsaka, PhD, MEd, MS

The Emerging Landscape on the Use of Machine Learning, Artificial Intelligence, Deep Learning, and Natural Language Processing Approaches in Drug Safety

Melvin Slaighter Munsaka, PhD, MEd, MS

AbbVie, United States

Senior Director, Head Safety Statistics

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