eMed : Videos

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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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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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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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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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Life Science Ventures Summit
Kauffman Foundation
7/13/2012
VideoSeries Resource
Summary:

Life science companies hold the promise of improving the world’s health and well-being. This two-day educational experience featured industry experts who answered the critical questions that founders must address to start and grow a viable life science startup.

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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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Startup Elements
Various
4/5/2012
VideoSeries Resource
Summary:

Startup Elements presented by Rock Health in partnership with the Kauffman Foundation.

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TRND Roadshow
McKew John
1/1/0001
VideoSeries Resource
Summary:

John McKew PhD, Chief, Therapeutics Development Branch, Division of Preclinical Innovation Therapeutics for Rare and Neglected Diseases (TRND) May 22, 2012, hosted by the Kauffman Foundation

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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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