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The Future of Pharmacovigilance Operations
Session Chair(s)
Nicole Schumacher Crow, MS
Senior Manager, Life Sciences
Deloitte LLP, United States
Pharmacovigilance (PV) systems have operated the same way for years, but recent changes in regulations, increasing workloads, and availability of new technologies are motivating companies to re-examine the way operations are conducted. This forum will examine these factors impacting the current PV workload and discuss future strategies for processes, governance, IT systems, and organizational structures.
Learning Objective : Design a strategy for a future pharmacovigilance system; Leverage knowledge from other industries; Optimize processes, procedures, organizations, and information technology.
Speaker(s)
A Workload Crisis in Pharmacovigilance, and What to Do About It
Alan Hochberg
Genentech, A Member of the Roche Group, United States
Principal Scientific Enablement Director, Scientific Enablement and Processes
Pharmacovigilance 2.0: Strategy for the Next Generation PV System
Nicole Schumacher Crow, MS
Deloitte LLP, United States
Senior Manager, Life Sciences
Implementation and Quality Assurance of a Global Pharmacovigilance System
Kerstin Geldmeyer-Hilt, PhD
Dr. Ebeling & Assoc. GmbH, Germany
Quality Manager