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Events and Networking

Expand Your Network at One of Biocom’s 150+ Annual Events

Where Should I Conduct My Clinical Trial and How Will the FDA Handle My Foreign Data

When:

Tue May 07 15:00:00 GMT 2019 - Tue May 07 17:00:00 GMT 2019

Where:

Biocom - McGraw Conference Room
10996 Torreyana Road Suite 200
San Diego, California 92121

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Clinical Wanderlust: Where Should I Conduct My Clinical Trial and How Will the FDA Handle My Foreign Data? 
Exploring the viability of Eastern Europe & Australia for First-in-Human Trials
 
US life science companies embarking on global clinical trials must consider how the FDA will handle foreign data generated. This discussion will introduce the FDA’s guidance on Acceptance of Foreign Clinical Studies, and how the FDA is addressing the challenge of processing the sheer volume of data and breadth of international inspections. The presenters will also present clinical, regulatory, import/export, and logistical benefits and challenges that you need to be aware of for your clinical trials in Australia, Czech Republic, Poland, and Slovakia.

Speakers:

  • Cameron Johnson, CEO, Nucleus Network
  • Jamie Weishaar, Business Development Executive, PCI Pharma Services
  • Mary Nguyen, PhD, Business Development Manager, Neox Clinical Research

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