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Tuesday, June 25 • 10:30am - 11:30am
#229: An Industry Collaboration on Pharmacovigilance Analytics

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-592-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss an initiative and how it is facilitating biopharmaceutical companies to enable earlier and systematic identification of potential safety issues to help minimize harm to patients, improve quality of analytic methods to improve product development, and deliver accelerated method development through collaboration and piloting. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Wednesday, June 26, 12:45-1:45PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Discuss methods for collaborating and innovating in analytics to improve patient safety; Identify how to build awareness of opportunities for greater alignment across the industry in signal detection and management; Describe industry best practices of current and future signal detection and management.

Chair

Andres Gomez, PhD, MPH

Speaker

Panelist
John Van Stekelenborg, PhD, MBA, MSc

Panelist
Neal Grabowski, MS


Speakers
AG

Andres Gomez

Vice President, Head of Epidemiology, Safety Science, and Analytics, Bristol-Myers Squibb
Dr. Gomez joined at Bristol Myers Squibb Company as an Associate Director of Pharmacoepidemiology in the Global Pharmacovigilance and Epidemiology department in 2003. He currently heads the epidemiology, safety science and analytics groups which is accountable for the real world research... Read More →
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 →
avatar for John Van Stekelenborg

John Van Stekelenborg

Director, Group Lead, Methods and Analysis, Johnson & Johnson
John van Stekelenborg is the Head of the Methods & Analysis group in the Global Medical Safety department of Janssen, the Pharmaceutical Companies of Johnson & Johnson. John has been with J&J since 2002 and assumed leadership of the M&A group in 2011 where he leads a group of data... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Forum |   09: Regulatory, Forum |   03: Data-Data Standards, Forum