Apr 10, 2018
APEC Pilot Center of Excellence Training on MRCT and GCP
8:00 AM to 5:00 PM
Location: Harvard Faculty Club, Cambridge
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.