Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Markets

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Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Markets is the first of many Remote Training Series that NAMSA does. This first series discusses and evaluates emerging markets and the opportunities and challenges that follow.

Science

Aligning Global Regulatory Strategy to
Decrease Approval Time in Emerging Markets
Seth J. Goldenberg, Ph.D.
Senior Principal Scientist
NAMSA

2
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

4
Understanding market opportunities is the
first step to planning global strategy

6
 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

7
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

8
Regulatory Approval Pathways
in Emerging Markets

9
Be aware of regulatory requirements and
timelines to help plan your global launch

10
Significance of Incorporating
Emerging Markets into “Get-to-
Market” Strategy at an Early Stage

11
Tailor global strategies to quickly gain
market access in emerging markets

12
 To view the full series about Aligning
Global Regulatory Strategy to Decrease
Approval Time in Emerging Markets
 Visit NAMSA Seminars
 For information about the regulatory
services NAMSA offers
 Check out our service page on
Regulatory and Consulting
 If you have any questions or would like to
request a quote
 Contact us at clientcare@namsa.com.

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About UCI Applied Innovation: UCI Applied Innovation is a dynamic, innovative central platform for the UCI campus, entrepreneurs, inventors, the business community and investors to collaborate and move UCI research from lab to market. About the Cove @ UCI: To accelerate collaboration by better connecting innovation partners in Orange County, UCI Applied Innovation created the Cove, a physical, state-of-the-art hub for entrepreneurs to gather and navigate the resources available both on and off campus. The Cove is headquarters for UCI Applied Innovation, as well as houses several ecosystem partners including incubators, accelerators, angel investors, venture capitalists, mentors and legal experts. Follow us on social media: Facebook: @UCICove Twitter: @UCICove Instagram: @UCICove LinkedIn: @UCIAppliedInnovation For more information: cove@uci.edu http://innovation.uci.edu/

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Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Markets

1. Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Markets Seth J. Goldenberg, Ph.D. Senior Principal Scientist NAMSA

2. 2 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

3. 3 “Emerging” Medical Device Markets

4. 4 Understanding market opportunities is the first step to planning global strategy

5. 5 What is an Emerging Market?

6. 6  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

7. 7 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

8. 8 Regulatory Approval Pathways in Emerging Markets

9. 9 Be aware of regulatory requirements and timelines to help plan your global launch

10. 10 Significance of Incorporating Emerging Markets into “Get-to- Market” Strategy at an Early Stage

11. 11 Tailor global strategies to quickly gain market access in emerging markets

12. 12  To view the full series about Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Markets  Visit NAMSA Seminars  For information about the regulatory services NAMSA offers  Check out our service page on Regulatory and Consulting  If you have any questions or would like to request a quote  Contact us at clientcare@namsa.com.

Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Markets

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Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Markets