Is this the End of Global Clinical Trials? How to Navigate Data Privacy and National Security Restrictions Affecting Cross-Border Data Transfers in the EU and China

3:00 PM - 4:00 PM (PDT), Wednesday, June 15, 2022

Join a distinguished panel of experts from U.S., EU, and China to discuss the extraordinary data privacy and security headwind facing global clinical development. Drug developers, hospitals, and CROs conducting multi-country trials are subject to stringent national and international health data regulations that apply to the collection, use, retention, protection, and cross-border transfer of clinical data. Failure to comply can result in enforcement actions as well as reputational damages. But the lack of harmonized standards and the increasingly onerous requirements not only are costly to operate, but they also can impose significant delays in drug development and adversely impact competitive positions.

This panel will examine the latest regulations on clinical data privacy, security, and transfer in key markets, including the management of human genetic resources in China and EU’s GDPR regime. The panel will also discuss emerging trends and industry efforts to develop a harmonized framework.


 

Moderator
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Executive Director for International Government Affairs and Trade Policy
Amgen Inc.
Speakers
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Policy Analyst
US Department of Commerce/International Trade Administration
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VP, Commercial Product Law & Chief Privacy Officer
Global Blood Therapeutics
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Partner
Ropes & Gray, LLP
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Statistician
European Medicines Agency (EMA)
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Assistant General Counsel, IP, Executive Director ? Legal
BeiGene, Ltd.