Joanne Morris, Clinical Research Quality Manager at TMG, is pleased to announce that our investigator GCP training, ”ICH GCP Principles and Part C, Division 5 of the Canadian Food and Drug Regulations as Described in the TMG Biomedical Research Site SOPs” now meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
TransCelerate Biopharma Inc. was formed in 2012 ”to advance innovation in research and development (R&D), identify and solve common R&D challenges and further improve patient safety.” It is comprised of 19 member biopharmaceutical companies.
Ms. Morris, commenting on the notification from TransCelerate stated: ”we are excited about what this means for our 35 investigators and 75 + study coordinators, who have gone through years of repetitive training on ICH GCP principles. Study personnel who now go through the TMG training program will be positioned to begin trials with TransCelerate member companies immediately, with no additional requirements for training on GCP or Part C, Division 5 of the Canadian Food and Drug regulations.”