GCP and MRCT Training in Canada
The MRCT Center, with partners, will conduct a training on Good Clinical Practice (GCP) and Multi-Regional Clinical Trials (MRCT) in Ottawa, Canada, in February.
Proceedings from the 2017 workshop entitled, “Data anonymization-a key enabler for clinical data sharing,” and co-hosted by the MRCT Center and European Medicines Association, have been published. LINK TO MORE
To maximize the interoperability of anonymized data and reduce the contractual barriers and administrative burden of data sharing, the MRCT Center developed three harmonized governance tools. LINK TO MORE
In order to maximize the interoperability of anonymized data and reduce the contractual barriers and administrative burden(s) of data sharing, the MRCT Center developed three harmonized governance tools as part of the PCORI Open Science Pilot Project.
The second Research, Development, and Regulatory Roundtable (R3) was held at the New York City offices of Ropes & Gray LLP On November 8, 2018. Stakeholders convened to discuss Right to Try vs. Expanded Access: Practical, Legal, and Regulatory Considerations.
The R3 provides a periodic, non-partisan forum wherein policymakers, regulators, legal counsel, and academicians may present, discuss, and deliberate cutting-edge issues in drug and device development, regulatory oversight of clinical trials, and human subjects research.
The MRCT Center will be facilitating didactic and case-based learning, presentations, and open discussion for regulators from Health Canada (reviewers and inspectors), and individuals from industry, academia, and non-profit organizations
Location and discussion topics to be determined.
Location and topic to be determined. Check back soon for more info.