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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.

Chair

Glenn Carroll, MBA

Speaker

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



Speakers
avatar for Glenn Carroll

Glenn Carroll

Principal, Strategy and Operations, Life Sciences, Deloitte Consulting
Glenn is a Principal in the Life Science practice with over 15 years of Pharmaceutical and Biotechnology consulting experience delivering strategic and operating model engagements. He has significant consulting experience in Compliance, R&D, Medical Affairs and Pharmacovigilance... 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 con... 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 devel... 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 Init... Read More →


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