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Wednesday, June 27 • 8:00am - 9:15am
#301: Automation in Pharmacovigilance: Doing More With Less

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-622-L04-P; CME 1.25; IACET 1.25; RN 1.25

The session will provide an overview of the current pharmacovigilance landscape and where the industry stands on automation versus manual processes with respect to adverse event processing, assessing, reporting and signaling. Functional areas will then be presented where companies can employ simple to sophisticated means to automate many of the resource intensive processes that will result in better consistency, higher quality and improved compliance.

Learning Objectives

Identify functions or processes that could benefit from improvements within their own pharmacovigilance practice especially through methods of automation; Explain how companies have successfully automated many aspects of the PV process and the benefits as well as liabilities such an automation can bring.

Chair

Axel Hagel

Speaker

Data Visualization and Analytics for Medical Monitors: Tech Adoption and Best Practices
Masha Hoffey, MS

Signal Detection in Social Media: Feasibility Assessment of Methods
Neal Grabowski, MS


Speakers
NG

Neal Grabowski

Director, Global Patient Safety and Labeling, Amgen Inc.
Neal Grabowski joined Amgen in 2014 as the Signal Management Officer responsible for signal detection and management processes including the implementation of numerous systems, process oversight and continual improvement and vendor management. He is currently the Head of Safety Signal... Read More →
AH

Axel Hagel

Partner, Foresight Group International
Mr. Axel Hagel is a Partner & Director, Foresight, IQVIA and has over 24 years of experience in the life sciences industry, specializing in the deployment of PV applications in North America, Europe, and Japan. He has unique experience and implementation skills for global safety systems... Read More →
avatar for Masha Hoffey

Masha Hoffey

Director of Clinical Analytics, PerkinElmer Informatics, Inc.
Masha Hoffey is Director of Clinical Analytics at PerkinElmer, where she oversees the Clinical Practice. She has over eight years of experience with clinical and regulatory applications, driving clinical strategy at Virtify, Inc. as well as clinical and regulatory metrics strategy... Read More →

Wednesday June 27, 2018 8:00am - 9:15am
Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session