Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Markets

Seth J. Goldenberg, Ph.D.

Senior Principal Scientist

NAMSA

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Outline

Evaluation of Emerging Market Opportunities Overview of Regulatory Approval Pathways in Emerging

Markets Significance of Incorporating Emerging Markets into “Get-

to-Market” Strategy at an Early Stage Challenges in Maintaining Global Regulatory Compliance

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“Emerging” Medical Device Markets

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Understanding market opportunities is the first step to planning global strategy

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What is an Emerging Market?

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Countries experiencing rapid growth and industrialization Emerging Market Global Players (EMGP) project from

Columbia University focuses on the following economies it considers “emerging”

» Argentina

» Brazil

» Chile

» China

» Hungary

» India

» Israel

» Korea

»Mexico

» Poland

» Russia

» Slovenia

» Taiwan

» Turkey

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In depth analysis of market opportunities in specific sectors is crucial Over estimation of market size can lead to not reaching sales

goals or lead to imperfect business and legal decisions downstream

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Regulatory Approval Pathways in Emerging Markets

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Be aware of regulatory requirements and timelines to help plan your global launch

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Significance of Incorporating Emerging Markets into “Get-to-

Market” Strategy at an Early Stage

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Tailor global strategies to quickly gain market access in emerging markets

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