The MRCT Center, in collaboration with Ropes and Gray, has led an effort to understand the key issues and implications of the GDPR on multi-regional clinical trials, clinical research, and public health

Global Regulatory Engagement

New Rules Released in India

On May 10, 2019, the MRCT Center, in collaboration with Ropes & Gray LLP, hosted a special presentation and discussion with the Drugs Controller General of India to discuss the final New Drugs and Clinical Trials Rules, 2019, that were released in March, 2019 by India’s Ministry of Health and Family Welfare.

Ethics, Conduct, and Oversight

Proactive Safety Surveillance Visioning Meeting

Over 40 stakeholders from industry, academia, regulatory and patient advocacy groups convened on May 3 to discuss and share their future visions for global participation in Proactive Safety Surveillance. LINK TO MORE

Focus Areas

Our efforts have resulted in the implementation of best practices, greater transparency, and improved safety for research participants in clinical trials.