Member Spotlight: Ayako Nakajima

Ayako shared with us that the Japan Affiliate has updated its’ Young Professional organization to strengthen Young Professional self-motivating activities. The Affiliate’s Young Leaders’ Management Team has been organized to plan Young Professional seminars and events, including the Young Professional “Basic Data Integrity for Manufacturing” Workshop at the Japan Affiliate Annual Meeting,; the “Basic Seminar for GMP Process Validation,” consisting of four sessions running from 12 July through 11 October; and “Life Cycle Management of Cleaning Validation”, on 14 November. Instructors for these workshops are senior industry professionals and Communities of Practice (CoP) members.

Students are also provided opportunities to learn and network – in May, a plant tour that included seminars was held at a commercial plant developing antibody drug substances for the Japanese Pharmaceutical Industry. This event for the students will be continued annually.

The Japanese Cabinet Office has been promoting Society 5.0 -- a “human- centered society that balances economic advancement with the resolution of social problems via a system that highly integrates cyberspace and physical space using IoT (internet of things), big data and Artificial Intelligence (AI)”. The ISPE Japan Affiliate recognizes Pharma Society 5.0, as “a society that balances the advancement of the pharmaceutical industry with overcoming challenges for human health by highly integrated innovative technologies”. It is increasingly important to proactively introduce the latest innovative technologies to more safely, economically, and effectively manufacture pharmaceutical products in order to contribute not only to patients and medical staffs, but to also maintain consideration of a sustainable society and the environment. In addition, it is expected that a combination of innovative technologies will create new values, improve the quality of life, and generate emerging business opportunities.

The Japan Affiliate has a goal of growing the ISPE in its region by raising awareness of the organization and enhancing membership. It plans to continuously evolve in terms of financial sustainability and development of human resources, and to proactively strengthen its’ cooperation with other APAC Affiliates and ISPE Headquarters. The Japan Affiliate also plans to promote the Japanese version of Facilities of the Future and continue to work closely with students and Young Professionals by growing its’ relationships with Universities and Japanese Government Agencies. It will continue to require that Japan Affiliate Members remain transparent and in full compliance with the Affiliate’s governance rules and regulations.

The Japan Affiliate has a full schedule planned for Fall and Winter 2019, including more educational seminars for Communities of Practice, ISPE training programs, and Young Professionals Seminars, as well as the translation and publication of several Good Practice Guides (GAMP Good Practice Guide - IT Infrastructure Control & Compliance, 2nd edition; Maintenance Communities of Practice – Good Practice Guide: Operations Management; and Sterile Products Processing Communities of Practice – Good Practice guide: Operations Management). It will also continue its’ collaboration with Academia, Government, and Industry Authorities. The Japan Affiliate’s Winter Meeting will be held in Osaka, Japan, in December.

It’s been – and continues to be - a busy and exciting year for the ISPE Japan Affiliate. Ayako has much to do as the Affiliate’s new Chair – and the first women in Japan to reach that position. Congratulations and best wishes for much success in this new role, Ayako!!!