Aligning Your Global Regulatory Strategy:
Decrease Time for Approval in Emerging Markets

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About:

Emerging markets increasingly represent significant revenue opportunities for medical device companies. 

China has most likely passed from “emerging” status into a “must enter” status as it rapidly becomes the 2nd largest health care market in the world. However, due to familiarity with the legal, regulatory, and business environments, many firms don’t look at China (or other key markets in Asia and Latin America) until after they enter the U.S. and Europe, even though these markets could represent larger opportunities than traditional markets.

This talk will focus on what it takes to enter key emerging markets and discuss some of the strategies medical device companies can employ to get to market quickly. 

Key topics will include: 

• Overview of emerging markets regulatory approval pathways 
• Significance of incorporating emerging markets into “Get-to-Market” strategy at an early stage 
• Legal, regulatory, and business strategies for speeding up access to emerging markets 
  

Presenter: 

Seth J. Goldenberg, PhD
NAMSA

Seth J. Goldenberg, PhD is a former regulatory chemist with the FDA and is currently a Senior Principal Scientist at NAMSA where he focuses on helping U.S. companies through the cultural and regulatory challenges of bringing pharmaceutical, biotech and medical device products to China. 

He has a strong record in drug development, FDA, business development, product licensing, grant writing, scientific patents, medical communications and collaborations with academia and industry. Dr. Goldenberg understands not only what it takes to carry out scientific studies but also the importance of communicating it with the global scientific community to foster partnerships and decrease the time it takes to get products to market.

He holds a PhD in Pharmacology from the University of Washington and an MS from the School of Biomedical Engineering at Drexel University.

MichBio U is generously supported by Bank of America Merrill Lynch.

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