Pilot Training on International Conference on Harmonisation Good Clinical Practice (ICH GCP): The MRCT Center is hosting a 3-day training for international regulators and professionals on ICH GCP.
Comments provided on: August 22, 2022
Comments provided to: Ministry of Health and Family Welfare, New Delhi, India
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:
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.
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.
Barbara Bierer, MD, MRCT Faculty Director will participate in a panel discussion on APEC regulatory convergence at the BIO 2018 conference in Boston, MA.
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.
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:
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.
