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Pharmacovigilance and Risk Management Strategies Conference

Session 9: Considerations for Medication Error Pharmacovigilance

Session Chair(s)

Jo  Wyeth, PharmD

Jo Wyeth, PharmD

  • Postmarket Safety Program Lead, DMEPA, OMEPRM, OSE, CDER
  • FDA, United States
Medication errors have a significant public health burden. This session will discuss the impact of medication errors, current state of medication error pharmacovigilance, and propose directions for building a pharmacovigilance medication error program for the future.
Learning Objective :

At the conclusion of this session, participants should be able to:

  • Recognize that medication error prevention requires a collaborative effort among regulators, industry, patients, healthcare providers, and other stakeholders
  • Identify differences and challenges in the approach for medication error pharmacovigilance versus adverse event pharmacovigilance
  • Describe current and emerging approaches for surveilling medication errors


Christina  Michalek, RPh

Medication Errors: Impact on the Victims

Christina Michalek, RPh

  • Medication Safety Specialist
  • Institute for Safe Medication Practices , United States
Reema  Mehta, PharmD, MPH


Reema Mehta, PharmD, MPH

  • Senior Director, Head of Risk Management and Safety Surveillance Research
  • Pfizer Inc, United States
Jo  Wyeth, PharmD

Roadmap for Medication Error Pharmacovigilance

Jo Wyeth, PharmD

  • Postmarket Safety Program Lead, DMEPA, OMEPRM, OSE, CDER
  • FDA, United States
Allan  Fong, MS

Natural Language Processing and Machine Learning with Patient Safety Event Reports

Allan Fong, MS

  • Research Scientist and Data Scientist
  • MedStar Institute for Innovation National Center for Human Factors in Healthcare, United States
Lubna  Merchant, PharmD, MS


Lubna Merchant, PharmD, MS

  • Deputy Office Director, OMEPRM, OSE, CDER
  • FDA, United States