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