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Wednesday, June 21 • 2:00pm - 3:15pm
#348: Exploring the Evolution of Signal Detection

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-537-L04-P; CME 1.25; IACET 1.25; RN 1.25

Since the initial release of GVP Module IX - Signal Management, pharmacovigilance organizations have gained a considerable amount of experience. The EMA has released Module 9 R2, which incorporates the key learnings to date. This session will explore notable changes, advances in signal management, and how organizations are adapting to meet the new guidelines.

Learning Objectives

Describe the updates to Module 9 and how they impact one's pharmacovigilance organization.

Chair

Stephen Knowles, MD, MRCP

Speaker

Evolving Signal Detection: Frequency-Based Approaches to Data Mining
Jeremy Jokinen, PhD, MS

Advances in Signal Management: Process, Data, and Methods
William Blackwell

Signal Management in Practice
Stephen Knowles, MD, MRCP


Moderators
avatar for Stephen Knowles

Stephen Knowles

Senior Director, Global Patient Safety, Medical and Benefit Risk Management, Eli Lilly and Company
Steve received his MD from the University of Newcastle Upon Tyne, UK and worked in the UK National Health Service for 17 yrs. He joined Eli Lilly in 2001 and has worked in pharmacovigilance since 2005 in various roles in both the UK and USA. In his current role, Steve has management... Read More →

Speakers
WB

William Blackwell

Director, Commonwealth Informatics
Bill is an expert in systems for signal detection and signal management. For more than 15 years his focus has been on systems to improve the assessment and management of drug safety signals. He has had the privilege to work with innovators within regulatory agencies, industry, and... Read More →
avatar for Jeremy Jokinen

Jeremy Jokinen

Vice President International Patient Safety and Global Risk Management, Bristol-Myers Squibb Company
Jeremy is the Vice President and Head, International Patient Safety and Global Risk Management, Worldwide Patient Safety, for Bristol-Myers Squibb. Jeremy is also active within numerous cross-industry working groups and is a deputy topic lead for ICH E19. Jeremy has over 20 years... Read More →

Wednesday June 21, 2017 2:00pm - 3:15pm CDT
S402ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  06: Safety-PV, Session