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Wednesday, June 19 • 10:00am - 11:00am
#324: Using Data Analytics for Good Pharmacovigilance Practices

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-642-L04-P; CME 1.00; RN 1.00

This session will consist of perspectives and case studies of how data-driven solutions are being leveraged to support the development of quality assurance strategies for pharmacovigilance activities and to generate quality evidence in relation to Good Pharmacovigilance Practice (GVP) compliance.

Learning Objectives

Investigate the use of data-driven solutions to develop quality assurance strategies for Good Pharmacovigilance Practice (GVP) activities and to generate quality evidence in relation to GVP compliance.

Chair

Kiernan Trevett, MSc

Speaker

Industry Update
Michelle Ruiz

Industry Update
John Okudjeto, MSc

MHRA Update
Sophie Radicke, MSc


Speakers
avatar for Kiernan Trevett

Kiernan Trevett

Principal Quality Lead, PDQ Quality Assurance Process GVP, Genentech, A Member of the Roche Group, United States
Kiernan joined Roche as a Principal Quality Lead focussing on pharmacovigilance quality assurance strategies. Previously, she worked as a GPvP Inspector at the MHRA for 1O years, with her most recent role being Expert GPvP Inspector. She contributed to the development of the EU GVP... Read More →
JO

John Okudjeto

Manager, Pharmacovigilance QA, Janssen Research & Development LLC, United States
John Okudjeto is a quality assurance professional with over ten years of experience in pharma and medical device manufacturing, supply change management, and pharmacovigilance auditing. John completed a Bachelor of Science in Biology/Chemistry from Georgia State University in 2010... Read More →
avatar for Sophie Radicke

Sophie Radicke

Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance... Read More →
MR

Michelle Ruiz

Principal Quality Data Analyst, Genentech, A Member of the Roche Group, United States
Michelle is a Principal Quality Data Analyst in Genentech's Product Development Quality organization. In her current role, Michelle focuses on identifying areas in the Pharmacovigilance domain where data analytics can transform business processes, as well as designing and delivering... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session |   08: RD Quality-Compliance, Session