Public Comments
Comments provided on: August 22, 2022
Comments provided to: Ministry of Health and Family Welfare, New Delhi, India
Focus Area: Capacity Building
ICH E17 Scientific and Regulatory Workshop Slides
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India: Progress and Opportunities
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Regulation of New Drugs and Clinical Trials Rules: Comments and Recommendations
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MRCT Center Annual Meeting
December 6, 2017 @ 8:00 am – 1:00 pm
MRCT Center 2017 Annual Meeting Agenda
MRCT Center 2017 Annual Meeting Proceedings
MRCT Center 2017 Annual Meeting Slides
MRCT Center 2017 Annual Meeting Keynote Slides
Key themes of the meeting included MRCT Center projects:
- Introducing a new project: Real World Evidence
- Core Competencies for Clinical Research Professionals
- Return of Individual Results: Genomics and Axes of Communication
- Preview: Global Clinical Trial Data Sharing Platform
The MRCT Center Annual Meeting is open to all MRCT Center stakeholders and the public.
1:00 PM- 4:30 PM, the MRCT Center Executive and Steering Committee met in closed session.
Deliverables
Projects
APEC Pilot Center of Excellence Training on MRCT and GCP
April 10, 2018 @ 8:00 am – 5:00 pm
This Asia-Pacific Economic Cooperation (APEC) Pilot Center of Excellence (CoE) training program on Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP) is a 3 1/2-day workshop — April 10-13, 2018 — hosted by the MRCT Center. It is specifically designed for regulators with responsibility for multi-regional clinical trials, drug review and approval, with priority to those from emerging economies.
The workshop goals are to advance the understanding of the ICH E17 (Multi-Regional Clinical Trials) and ICH E6(R2) (Good Clinical Practice) guidelines to facilitate their adoption and implementation. Case-based learning, presentations, and open discussion of scientific, statistical, and practical approaches will be used. The Faculty will include regulators from the USFDA, EMA, Health Canada and others with the assistance of academic and industry leaders.
Deliverables
Projects
BIO 2018 conference
June 4, 2018 @ 2:30 pm – 4:00 pm
Barbara Bierer, MD, MRCT Faculty Director will participate in a panel discussion on APEC regulatory convergence at the BIO 2018 conference in Boston, MA.
Deliverables
Projects
OPPI Conference
June 20, 2018 @ 2:00 pm – 4:00 pm
Dr. Barbara Bierer, MRCT Center Faculty Director, and Mr. Mark Barnes, MRCT Center Faculty Co-Director, will co-host a conference with the Organisation of Pharmaceutical Producers of India (OPPI) at their offices on clinical trials regulatory issues.
Deliverables
Projects
MRCT Center Annual Meeting
December 5, 2018 @ 8:00 am – 5:00 pm
The MRCT Center Annual Meeting was held in the morning of December 5, 2018 (8:00 AM -1:00 PM).
The keynote speaker was Guido Rasi, Executive Director of the European Medicines Agency (EMA).
Click here to view the Annual Meeting Agenda.
Click here to view the Annual Meeting Proceedings
Click here to view the Annual Meeting Slides (for sponsors only).
The principal topics discussed at the MRCT Center 2018 Annual Meeting were:
- European Union General Data Protection Regulation (GDPR)
- Representation of Diverse Populations
- Advancing the Study of Clinical Trials
- Capacity Building
- Health Literacy in Clinical Research.
The meeting was followed by the Executive and Steering Committee meeting in the afternoon (1:00 PM -5:00 PM), which was open to MRCT Center sponsors only.
Deliverables
Projects
Health Canada ICH GCP and MRCT Training
February 26, 2019 @ 9:00 am – 5:00 pm
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
Learning Objectives:
- Describe the standards of Good Clinical Practice (GCP) and key considerations in Multi-Regional Clinical Trials (MRCTs) design as set out in ICH E6(R2) and ICH E17 guidance, with particular focus on how the guidelines are applied by Health Canada.
- Use case studies, to apply the changes of ICH E6(R2) addendum and ICH E17 to increase the acceptability of MRCT data by multiple regulatory authorities
- Demonstrate practical approaches that Health Canada may take to fulfill the requirements of ICH E6(R2) and ICH E17 consistent with ICH standards
For Regulators:
- Describe and demonstrate best practices to assess clinical trial regulatory submissions by Health Canada, including study design, data packages, essential documents, reports, and filings for alignment with ICH GCP and MRCT
- Describe inspection methodologies that may be taken by Health Canada to assess clinical trial conduct for alignment with ICH GCP and MRCT standards, including review of corrective actions.
For other Stakeholders:
- Gain better understanding and knowledge of Health Canada expectation with regard to compliance with the Canadian clinical trial regulations.
- Gain better understanding and knowledge of Health Canada GCP inspection processes to better prepare for an inspection
Click here to download a Flyer
Deliverables