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
Ethics, Conduct, and Oversight
Bioethics Collaborative May 2
The most recent meeting of the Bioethics Collaborative took place May 2 in Boston and addressed the impact of mobile devices and wearable technologies on the design and conduct of clinical research. LINK TO MORE
Focus Areas
News
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. Current safety surveillance systems rely upon analysis of spontaneous, voluntary reports and of administrative claims, electronic medical records, and some post-marketing pharmacovigilance studies.
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.
Mar 29, 2019
MRCT Center participated in two Health Literacy workshops
Plain Language for Health. A Writing and Design Workshop for Health Research and Practice (March 28-29) The MRCT Center co-sponsored a two-day workshop held by Tufts on March 28th-29thfocused on how to use plain language principles to improve research-related communications. Approximately 70 attendees from academic medical centers, the public health field and pharmaceutical companies attended.
Events
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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”
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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
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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.