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Tuesday, June 26 • 4:15pm - 5:30pm
#277: Pharmacovigilance: No Longer Going it Alone

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-605-L04-P; CME 1.25; IACET 1.25; RN 1.25

In the past, pharmacovigilance departments have often been limited in the way they interact with other functions within pharmaceutical organizations. The traditional function of the Safety organization has been to prevent harm to patients, and to react to emerging evidence of potential harm. Thus we have been reactive rather than proactive, and tactical rather than strategic.This is now changing. The growing emphasis on health technology assessment in the health care field requires strategic contributions from Safety. And expectations of a more patient-centered approach now mean that we must help patients manage their adverse drug reactions, in addition to simply characterizing and communicating risks. This session will describe how this transformation is taking place, resulting in a Safety organization that is a full strategic partner in development, and a key supporting function for commercialization. Strong, cross-functional safety governance is essential for effective decision making; means for assessing and improving safety governance maturity will be presented.

The session will also describe the evolving role of the safety statistician in helping multidisciplinary safety teams to think more quantitatively, and to improve the conversations we are having about safety evaluation during drug development.

Learning Objectives

Identify the forces in the healthcare system which are producing strategic changes in the safety organization; Assess the maturity of safety governance in your organization and identify opportunities for improvement: Describe how to form more effective partnerships with safety statisticians to drive the clinical decision-making process with medical judgment that is informed and supported by quantitative assessments of the data.


Alan M. Hochberg


Evolving the Strategic Framework for the Safety Department
Alan M. Hochberg

Building Better Governance: The Maturity of Safety Governance Models and Considerations for Organizations
Ellenie Nichols, MEd

Multi-Disciplinary Approach for Successful Collaboration: Improving Conversations to Achieve Impact in Drug Development
Amit Bhattacharyya, PhD

avatar for Amit Bhattacharyya

Amit Bhattacharyya

Vice President, Biometrics, ACI Clinical
Amit Bhattacharyya, PhD, is the Vice President of Biometrics at ACI Clinical, a niche service provider specializing in independently managing Safety Expert Committees. Amit is a thought leader in Drug Safety domain. Amit's also brings 20+ yrs at GSK in various global statistical leadership... Read More →
avatar for Alan Hochberg

Alan Hochberg

Principal Scientific Enablement Director, F. Hoffmann-La Roche, Switzerland
Alan Hochberg is a Scientific Enablement Leader at Roche in Basel, involved in bringing innovations into the pharmacovigilance system. He was formerly with ProSanos, where he developed and evaluated signal-detection algorithms. He has worked in bioinformatics and biomedical engineering... Read More →
avatar for Ellenie Nichols

Ellenie Nichols

Global Patient Safety and Labeling, Safety Governance Lead, Amgen Inc.
Ellenie Nichols is Safety Governance Lead in Global Patient Safety and Labeling for Amgen, Inc. She has over a decade of experience working in Regulatory and Safety. Her current focus is on the impact and benefit of strategically aligning business practices with the safety governance... Read More →

Tuesday June 26, 2018 4:15pm - 5:30pm EDT
Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session