✅ The IABS GHS Workshop 2025 concluded this week in Tokyo after three days of intense discussion, knowledge exchange, and collective reflection.

Beyond the technical content, the workshop successfully offered participants a new perspective on how specifications can be designed and applied, not only to ensure product quality, but also to better serve patients and support global access.

From regulatory frameworks to case studies and cross-sector dialogue, each session contributed to a stronger, more forward-looking enhanced approach to setting specifications based not on manufacturing consistency but rather using risk-based assessments of critical quality attributes and ensuring those are within ranges/limits which ensure patient safety and product efficacy.

👉 The mission of IABS to bring together stakeholders around critical public health topics was clearly achieved.

Thank you to all speakers, participants, moderators, and sponsors for making this meeting a success.

#GHS2025 #IABSevent #Specifications #GlobalHarmonization #PatientCentric

Patrice Riou Bénédicte Mouterde Minkyung (Lynn) Kim, PharmD, MBA, MS Dean K. Smith, Ph. D Daisy Nie Andrew Chang Bart van Montfort – PhD Kaushik Sarkar Yoji Sato Shawn Novick Shin Kawamata Cristiana Campa Robin Levis

FUJIFILM Biosciences Sanofi Novo Nordisk Takara Bio USA, Inc. Kyowa Kirin Co., Ltd. Meiji Seika Kaisha, Ltd. Asahi Kasei Bioprocess America, Inc.