TMG’s GCP training program updated to reflect Addendum to ICH GCP E6(R2)

TMG’s revised ICH GCP training program, reflecting the Integrated Addendum to ICH GCP E6(R2), has met the minimum criteria for mutual recognition by TransCelerate BioPharma Inc. Investigators and site personnel who complete a TransCelerate recognised training program such as TMG’s may be able to use their training certificates across TransCelerate Member Companies, of which there are currently 18. This means that study personnel can spend less time completing redundant company-specific training, allowing for more focus on protocol-related work.

To date, the EMA remains the only regulatory authority to have announced their adoption of ICH GCP E6(R2). Nevertheless, training programs must be updated to reflect the Addendum to retain their mutual recognition status by TransCelerate Biopharma Inc.