Japanese TMF Community Update: Recent Highlights Including TMF RM Survey Review

About this session

Part of Session 4, Track E: TMF Culture and Engagement (Chair: Laurel-Ann Schrader, Transperfect).

TMF challenges are rarely caused by standards alone. More often, they arise from differences in interpretation, local regulatory practice, and organisational/local culture itself. These are why local community is important, and there are many local TMF communities around the world. Japanese community is one of them and it has been very active since it’s launch in Q1 2025 engaging JP TMFers from Sponsor, CRO, service provider, academia and consultant.
In this session, first presenter will highlight recent status of the JP TMF community including #members, F2F workshop agenda and conference exposure.
Second speaker presents a recent initiative from the JP TMF community: across-organisational survey across 25 companies exploring how the TMF Reference Model is interpreted and applied in practice. Designed to support readiness for upcoming TMF standards, the survey identified areas of variability challenges and practitioner insights to inform future alignment and model evolution.

Speakers

• YK

  Yuto Kanda

  Chugai Clinical Research Co., Ltd.

  Speaker

• MN

  Mai Nishihara

  Chugai Clinical Research Co., Ltd.

  Speaker

• MT

  Miyuki Taguchi

  inSeption Group

  Speaker