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First Steps in the Regulatory Process
Chong Su Mien
10/23/2011
VideoSeries Resource
Summary:

Paul Yock interviews Su-Mien Chong, regulatory consultant, on assembling a regulatory team.

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510(k) vs. PMA Regulatory Strategies
Holstein Howard
7/28/2011
VideoSeries Resource
Summary:

Paul Yock interviews Howard Holstein, regulatory attorney, on 510(k) vs. PMA regulatory strategies.

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Assembling a Regulatory Team
Chong Su Mien
7/28/2011
VideoSeries Resource
Summary:

Paul Yock interviews Su-Mien Chong, regulatory consultant, on assembling a regulatory team.

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Investigational Device Exemptions
Holstein Howard
7/28/2011
VideoSeries Resource
Summary:

Paul Yock interviews Howard Holstein, regulatory attorney, on investigational device exemptions.

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Understanding the FDA
Holstein Howard
7/28/2011
VideoSeries Resource
Summary:

Paul Yock interviews Howard Holstein, regulatory attorney, on understanding the FDA.

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Working with the FDA
Chong Su Mien
7/28/2011
VideoSeries Resource
Summary:

Paul Yock interviews Su-Mien Chong, regulatory consultant, to discuss working with the FDA.

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Regulatory Case Studies
Holstein Howard
7/23/2011
VideoSeries Resource
Summary:

Paul Yock interviews Howard Holstein, regulatory attorney, discussing some regulatory case studies.

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Global Entrepreneurship Lab: Understanding Growth Around the World
Zoller Ted
6/21/2011
VideoSeries Resource
Summary:

Ted Zoller, Vice President of Entrepreneurship at the Kauffman Foundation and Associate Professor at the University of North Carolina, Chapel Hill, discusses the Global Entrepreneurship Lab.

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Case Example: The Acclarent Regulatory Strategy
Chong Su Mien
7/28/2010
VideoSeries Resource
Summary:

Paul Yock interviews Su-Mien Chong, regulatory consultant, on the Acclarent(tm) regulatory strategy.

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Entrepreneurial Thought Leaders Lecture Series
Hansson David Heinemeier
1/20/2010
VideoSeries Resource
Summary:

Danish-born David Heinemeier Hansson is the programmer and creator of the popular Ruby on Rails web development framework and the Instiki wiki. He is also a partner at the Web-based software development firm 37signals, based in Chicago. Ruby on Rails provides a "basic development environment" for programmers, according to Wikipedia.org. Based on the programming language Ruby (developed by Japanese programmer Yukihiro Matsumoto in 1995), Ruby on Rails focuses on user interface and "convention over configuration"; meaning, developers can focus on the unique qualities of their Web site or program rather than the building blocks that every application may require. Released in 2004, Ruby on Rails has been incorporated into many applications used by some of the biggest companies, from Twitter to Apple's 2007 release of Mac OS X v.10.5 "Leopard." Aside from his development of Ruby on Rails, Heinemeier Hansson also works as a partner for Web-based software development firm 37signals. Joining the company in 2003, he has helped develop Basecamp, Campfire, Backpack and other Web-based applications. Working in similar ways like Web-based e-mail services like Yahoo! e-mail and Google's Gmail, 37signals hosts a broad range of IT services for companies, including project management to information-sharing. The firm's software has been used by Kellogg's, Sun Microsystems and even Obama '08. Hansson received his bachelor's degree from the Copenhagen Business School in 2005. In that same year, he moved to Chicago and received Hacker of the Year honors for his work on Ruby on Rails from Google and O'Reilly Media. He runs a blog called LoudThinking.com.

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