China Revisited: Recent Developments Affecting Research Involving the People’s Republic of China (“PRC”) - The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

The Research, Development, and Regulatory Roundtable (R3) is a forum to discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Meetings convene policymakers, legal counsel, academicians, industry representatives, and global regulators. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.

This hybrid meeting is open to sponsors of the Research, Development, and Regulatory Roundtable.

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In September 2023, the MRCT Center’s R3 forum devoted a session entirely to issues that arise when conducting research involving the PRC.  Since that time, there have been several developments that affect research with a nexus to the PRC.  These include updates to the PRC’s requirements for processing sensitive personal data in the context of clinical trials, scrutiny of arrangements involving the PRC from an export control perspective, the implementation of the DOJ’s Bulk Data Rule, and reliance by different components of the U.S. Department of Health and Human Services on Executive Order 14117 (which served as the basis for the DOJ Bulk Data Rule) to make policy announcements regarding research involving the PRC.  

This session of the MRCT R3 will explore these latest developments and discuss additional changes that may be on the horizon.  Speakers will include Ropes & Gray partners Katherine Wang, who routinely counsels life sciences clients on PRC laws and regulations, Brendan Hanifin, who advises companies on customs/export controls and CFIUS, and David Peloquin, who advises clients on a wide range of clinical research and data protection matters.  

For more information, please email at MRCT@BWH.HARVARD.EDU

Deliverables