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Strategies for Global Launch of Medical Devices and Successful Clinical Trials
Start Date: 4/26/2017Start Time: 4:00 PM
End Date: 4/26/2017End Time: 5:30 PM

Event Description
BIOMED Seminar

Thinking Globally, Acting Locally: Strategies for Global Launch of Medical Devices and Successful Clinical Trials

Seth J. Goldenberg, PhD
Director, Product Development Strategy
North American Science Associates (NAMSA)

The global healthcare and healthcare service market will maintain steady growth due in large part to an aging population that is living longer and to improved healthcare services in emerging markets that include China, Brazil, India, Japan, Israel, and South Korea, among others. It is interesting to note that countertrends seem to be developing in the medical device space. For example, hospital utilization of medical devices has slowed significantly, reimbursements continue to tighten, and there was a first-time global decrease (5%) in US pre-market approvals (PMAs) in 2012, a trend that is continuing. This talk will focus on what it takes to bring a medical device to market globally, with a particular emphasis on running successful clinical trials for high risk devices.

Seth J. Goldenberg, PhD, is currently Director of Product Development Strategy with North American Science Associates (NAMSA), and previously was Director of Global Regulatory at NAMSA, as well as a former member of the US Food and Drug Administration (FDA). He holds a PhD in Pharmacology from the University of Washington and an MS from the School of Biomedical Engineering, Science and Health Systems at Drexel University. At NAMSA, Dr. Goldenberg works with over 1,000 NAMSA associates to develop global strategies for success taking into account regulatory, clinical, testing, and business considerations around the world. He has supported companies in direct interactions with the US FDA, several notified bodies, CFDA, ANVISA, MFDS, and many other global regulatory bodies.

Prior to joining NAMSA, Dr. Goldenberg founded a consulting company based in Shanghai supporting medical device market entry and local Chinese firms. Dr. Goldenberg understands not only what it takes to carry out scientific study, but also the importance of communicating it with the global scientific community to foster partnerships and collaboration, demonstrated by his strong publication record in such journals as Cell, Science, and Nature Cell Biology that have been cited over 1,200 times.
Contact Information:
Name: Ken Barbee
Phone: 215-895-1335
Email: barbee@drexel.edu
Seth Goldenberg
Papadakis Integrated Sciences Building (PISB), Room 120, located on the northeast corner of 33rd and Chestnut Streets.
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