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Tuesday, June 21 • 9:00am - 10:00am
#201: Transforming PV at the MHRA

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-539-L04-P ; CME 1.00; RN 1.00

This session will discuss the MHRA concept proposal on Yellow Card Biobank, Post EU Exit Vigilance and developments with the introduction of a New Multi-vigilance system at MHRA including the use of AI for case management.

Learning Objectives

Describe new initiatives within the MHRA including case management using artificial intelligence.

Chair

Mick Foy

Speaker

Vigilance Transformation at MHRA
Phil Tregunno

Device Safety Vigilance
Sarah Vaughan

Industry Update
Vicki Edwards, RPh


Speakers
avatar for Mick Foy

Mick Foy

Deputy Director of Patient Safety Monitoring, MHRA, United Kingdom
Mick Foy has been with the MHRA for more than 30 years, he is a member of the MHRA’s Senior Leadership team and has recently been appointed Deputy Director of Patient Safety Monitoring . Amongst his responsibilities is to lead MHRA efforts to build PV capabilities in other countries... Read More →
avatar for Vicki Edwards

Vicki Edwards

Vice President, Pharmacovigilance Excellence and International QPPV, AbbVie, Inc., United Kingdom
Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community... Read More →
avatar for Sarah Vaughan

Sarah Vaughan

Head of Vigilance Development, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, with 6 years as the Pharmacovigilance Information Unit Manager. She has been MHRA representative on the MedDRA Points to Consider Group, and worked on implementation of the 2012 EU Pharmacovigilance legislation... Read More →

Tuesday June 21, 2022 9:00am - 10:00am CDT
Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  01: ClinSafety-PV, Session |   09: Regulatory, Session