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Wednesday, June 21 • 10:30am - 11:45am
#320: The Brave New World: The Ongoing Globalization of Pharmacovigilance

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Discuss the challenges, benefits, best practices, and lessons learned in globally harmonizing one's pharmacovigilance organization.


Glenn Carroll, MBA


Best Practices and Lessons Learned in Globalizing and Harmonizing a Pharmacovigilance Organization
Mirza Rahman

Developing a Global Pharmacovigilance System for Expanding Markets: How You May Steer Your Boat Across Safe Waters
Sandra van der Poel

Successes and Challenges in Achieving and Maintaining Oversight of Pharmacovigilance Affiliates
Jeffrey Ho

avatar for Glenn Carroll

Glenn Carroll

Principal, Deloitte, United States
Glenn Carroll is a principal in our life science strategy practice with over 15 years pharmaceutical and biotech experience. Glenn leads Deloitte's US Safety and Medical practices. He has a strong track record in delivering strategic and operational excellence, specifically in the... Read More →
avatar for Jeffrey Ho

Jeffrey Ho

Principal, Navitas Life Sciences
Jeffrey Ho oversees Navitas Life Sciences’ PV and Medical offerings. He has nearly 20 years of global experience consulting in pharmacovigilance and managed numerous implementations of cross-functional transformations extending from headquarters into affiliates. Navitas has conducted... Read More →
avatar for Sandra van der Poel

Sandra van der Poel

Principal Consultant, Xendo Pharmacovigilance B.V.
Sandra van der Poel – Smet, is working for a CRO named Xendo (formally Vigilex) and appointed as contracted EEA QPPV on behalf of different global clients. Sandra has over 25 years of work experience in different pharmaceutical companies, initially she started in clinical development... Read More →
avatar for Mirza Rahman

Mirza Rahman

Vice President, Global Head of Pharmacovigilance and Medical Afairs, Otsuka Pharmaceutical Development & Commercialization, Inc.
Dr. Mirza Rahman is the Vice President, Clinical Safety & Pharmacovigilance, and the Global Head of Pharmacovigilance at Otsuka Pharmaceutical Development & Commercialization (OPDC), Inc. Shortly after joining Otsuka in 2013, he led the Otsuka Global Pharmacovigilance Reform Initiative... Read More →

Wednesday June 21, 2017 10:30am - 11:45am CDT
N226 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  06: Safety-PV, Forum