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
Home
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.
LINK TO MORE
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
News
May 03, 2019
Kick-off of Proactive Safety Surveillance Project
As the launch to the project, on May 3, 2019, the MRCT Center invited over 40 representatives from industry, academia, government, and patient advocacy groups to discuss a vision for aglobal, cooperative model of a more proactive, predictive safety surveillance system than exists today.
Apr 22, 2019
Launch of Proactive Safety Surveillance Initiative
Ensuring the safety of biological products, drugs, and devices in healthcare is the shared responsibility of regulatory, academic and industry-related stakeholders.
Apr 22, 2019
New Rules Released in India
On March 19, 2019, the Ministry of Health and Family Welfare of India released the “New Drugs and Clinical Trials Rules, 2019.”[1] These rules included significant definitions, clarifications, opportunities, and expectations that, together, improved the clinical trial regulatory environment in India.
Events
-
Jun 25, 2019
Presentation at DIA Global Annual MeetingDr. Barbara Bierer, MRCT Faculty Director, will co-present at the 2019 DIA Global Annual Meeting: “Conversations with the Participant: Layperson Summaries and Return of Results”
-
Aug 01, 2019
Meeting of the Research, Development, and Regulatory Roundtable (R3)Discussion topic: Legal and Ethical Issues in the Enrollment of a Company or Institution’s Own Employees and/or Students in Research Studies
-
Nov 07, 2019
Meeting of the Research, Development and Regulatory Roundtable (R3)Discussion topics to be determined.
Our efforts have resulted in the implementation of best practices, greater transparency, and improved safety for research participants in clinical trials.