Module 1 2021

25/06/2021

TOPRA MSc Module 1 – Strategic Planning in Regulatory Affairs May 2019

Regulatory Strategy for the Emerging Markets – Far East, Africa, Middle East, Latin America Elliot Simonian, Senior Director, Regulatory Affairs, PPD www.ppdi.com Elliot.Simonian@ppdi.com

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

 Appreciation of commercial importance of Emerging Markets  Broad understanding of the evolution of the regulatory model in these countries  Contrast regulatory challenges and strategies with ICH/ICH-like countries  Practical points of consideration when building and executing regulatory strategies for Emerging Markets

The Organisation for Professionals in Regulatory Affairs

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