Is This the End of Global Clinical Trials? What You Need to Know To Navigate the Complex Data Privacy and National Security Restrictions Across International Markets from Europe to China

3:00 PM - 4:00 PM (PDT), Wednesday, June 15, 2022 ・ Upper Level, Session Room 4

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
photo
Executive Director for International Government Affairs and Trade Policy
Amgen Inc.
Speakers
photo
Vice President, Commercial & Chief Privacy Officer
Global Blood Therapeutics
photo
Senior Advisor, Multi-Regional Clinical Trial Center of Brigham and Women’s Hospital and Harvard; Partner, Ropes & Gray
Ropes & Gray
photo
Statistician
European Medicines Agency
photo
Assistant General Counsel, Intellectual Property
BeiGene USA, Inc.