The MRCT Center will host a workshop to discuss the evolution of a harmonized framework of core competencies for clinical research professionals and its application to real world experiences.
Fifteen real life case studies applying the core competencies by industry, professional societies and academia in the US and global settings will be presented.
This will be an opportunity to learn more about the application of the core competencies for those seeking to apply the competencies in their own environment. Also the workshop will provide an opportunity for participants to provide feedback and discuss potential future revisions for the competency framework. Potential future projects for the work group will also be discussed.
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.
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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.
