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The Brave New World: The Ongoing Globalization of Pharmacovigilance
Session Chair(s)
Glenn Carroll, MBA
Principal
Deloitte, United States
Increasing pharmacovigilance requirements and guidelines by global regulatory agencies is causing the pharmaceutical industry to globalize and harmonize across pharmacovigilance organizations. Practical strategies for breaking down silos, sharing best practices and expected outcomes will be presented. Topics to include: process harmonization, optimal management of local safety offices, optimal governance models, and successful change management.
Learning Objective : Discuss the challenges, benefits, best practices, and lessons learned in globally harmonizing one's pharmacovigilance organization.
Speaker(s)
Best Practices and Lessons Learned in Globalizing and Harmonizing a Pharmacovigilance Organization
Mirza Rahman
Otsuka Pharmaceutical Development & Commercialization, Inc., United States
Senior Vice President, Global Head of Pharmacovigilance
Developing a Global Pharmacovigilance System for Expanding Markets: How You May Steer Your Boat Across Safe Waters
Sandra van der Poel
UCB Biopharma sprl, Belgium
Director PVQA
Successes and Challenges in Achieving and Maintaining Oversight of Pharmacovigilance Affiliates
Jeffrey Ho
Perigent, United Kingdom
Director