ABSTRACT
The Japanese perspective on knowledge management (KM) comes to us by kind permission of International Society for Pharmaceutical Engineering (ISPE) as a reprint of an article authored by Dr. Yukio Hiyama originally published in May 2014 in an e-journal on knowledge management for the pharmaceutical industry. This chapter presents personal reflection on knowledge management related issues at ICH and in regard to the regulatory framework development for 2005 Pharmaceutical Affairs Law (PAL) change of Japan. In 2008 at the Quality Implementation Working Group (QIWG) first meeting in Portland (OR), there were three breakout sessions for quality by design, pharmaceutical quality system, and knowledge management. Feedback from the training sessions, which were held in the three ICH regions, showed that there were not significant questions about knowledge management at that time. Knowledge transfer for rebuilding is even more challenging. Training of shrine/temple carpenters is difficult because they have rare opportunities to use their expertise.
