Purpose
The New Pharmaceutical Technology and Engineering (NPTE) Institute was established in Japan for the purpose of contributing to the improvement of healthcare standard through research and advancement of pharmaceutical development, pharmaceutical manufacturing technology and pharmaceutical engineering. It conducts following activities.
●The NPTE Institute invites lecturers in the area of the pharmaceutical technology, manufacturing
technology, plant management, quality control and pharmaceutical regulation from Japanese and foreign
pharmaceutical companies, regulatory authorities and research institutes including Universities to its
conferences.
●The NPTE Institute supports activities by its related international/domestic academic societies, research
institutes and others, to achieve the purpose of the Institute.
●The NPTE Institute provides opportunities for pharmaceutical companies to share/exchange opinions on
challenges, such as quality assurance and factory operation, through events like international/domestic
pharmaceutical plant visit tour.
●The NPTE Institute encourages young researchers through a subsidy, providing admission fee and others to
attend NPTE Conference and Pharmaceutical Technology Conference.
Outline of Activity
The NPTE Institute organizes its NPTE Conference once a year to supply the latest information on
Japanese/foreign pharmaceutical technologies and pharmaceutical engineering to Japanese pharmaceutical
companies and universities. It invites 12 to 14 distinguished lecturers from Japanese/foreign pharmaceutical
companies, universities and regulatory agencies including PMDA, FDA and EMA. It has nearly 700 participates
in total during the two-day conference.
Pharmaceutical industry faces further globalization and it is required to develop new medicines on the
global scale. On the other hand, In Japan, Japan’s government newly announced Encouragement of Generic Drugs
Use Policy as one of their healthcare financial policies. Pharmaceutical Industry, so to speak, has entered
the era of the industrial revolution; further selection and concentration is necessary for brand drug
manufacturers, both stabilization of supply and expansion of production scale are required for generic
pharma at the same time, furthermore, challenges for generic pharma is now for CMOs, such as securing the
amount of drug supply and managing long-term listed drugs.
In addition, global competitions for survival is getting fiercer and global aspects have became essential in
the area of new pharmaceutical developments including biopharmaceutical products and new innovative drugs
technologies. On the other hand, solid dosage form manufacturing is now facing a paradigm shift from
existing batch system to on-demand manufacturing such as continuous manufacturing system. Meanwhile, ICH
guidelines have advanced from Quality by Design (QbD) (Q8), Risk Management (Q9), Quality System (Q10) and
Development and Manufacture of Drug Substances (Q11) to Pharmaceutical Product Lifecycle (Q12). The global
quality assurance and pharmaceutical development trend is undergoing significant changes, now.
The NPTE Institute will promptly reflect these changes of circumstances and provide opportunities to share
information and exchange opinions with participants through further substantial program with well-balanced
themes, such as pharmaceutical development for not only low molecule but also high molecule drugs, case
studies on pharmaceutical technology & factory engineering, regulatory science as well as pharmaceutical
process engineering.
As mentioned above, the NPTE Institute is a non-profit organization operating for the purpose of the
advancement of the global pharmaceutical technology and the improvement of the healthcare standard. Because
of the nature, it offers conferences without administration fee, but only abstract reprints & networking
party fees; the incomes will be used for a part of operating expenses. Exhibition for co-sponsoring
pharmaceutical companies, raw material manufacturers and device manufacturers will be held at the very next
to the conference hall. The exhibition is a good place to exchange information and understand industry
trends, as well as the conferences.
The NPTE Conference is supported by the Japan Society of Pharmaceutical Machinery and Engineering (JSPME),
ISPE Japan, the Pharmaceutical Society of Japan, the Academy of Pharmaceutical Science and Technology Japan
(APSTJ), the Society of Powder Technology Japan (SPTJ), the Association of Powder Process Industry and
Engineering Japan (APPIE), the Japan Society of Drug Delivery System (DDS) and Parenteral Drug Association
(PDA), Japan Chapter.
Pharmaceutical Technology Conference
The NPTE Institute holds Pharmaceutical Technology Conference once or twice a year, focusing especially on
pharmaceutical technology. In the past, it had the themes on unit operations of either granulation,
tableting or coating, as well as quality control methodology using PAT and QbD, tablet printing technology
to enhance tablet recognition which is one of medical front demands, rationalization of the shift from
laboratory development to product manufacturing, flexibility to control production volume & product
types, pharmaceutical development from pharmaceutical engineers’ points of view and the latest useful topics
from production site based on the latest regulation trends including continuous manufacturing technology ---
which is drawing an attention. The Institute will continue to introduce innovative topics further and
provide the opportunity to foster pharmaceutical engineers who will meet with the needs of the
pharmaceutical technology on site.
Pharmaceutical Plant Visit Tour
The NPTE Institute regularly holds domestic/European latest pharmaceutical plant visit tour. It invite
applications from the public; approximately 10 participants from pharmaceutical researchers, pharmaceutical
engineers, plant manager, pharmaceutical corporate manager, pharmaceutical researchers from universities in
Japan visit about 4 to 5 world’s latest pharmaceutical plants in a week.
The main themes of the visit are the state-of-the-art facilities with Containment Technology, generic drug
production plant which is flexible to Multi-products & Items production, Contract Manufacturing plant,
outstanding pharmaceutical plants which won the Facility of the Year Award of ISPE and plant installed
Continuous Manufacturing system before others in the industry.
During the tour, the NPTE Institute arranges discussion times with pharmaceutical engineers and
manufacturing manager of plants actively. Delegates can have a good opportunity to collect new ideas not
only on pharmaceutical technology but also pharmaceutical plant concept and plant operation.
Young Researcher Encouragement
The NPTE Institute invites about 10 young researchers a year to NPTE Conference and Pharmaceutical
Technology Conference. The Institute will cover their transportation expenses and accommodation costs, as a
part of its foster youth action. It is aimed at supporting students (enrolled in a master degree or higher
course of a college/university) who will lead pharmaceutical technology and engineering in the future. The
Institute will offer opportunities for the students to attend lectures by the world’s latest speakers,
exchange opinions directly and meet with many senior researchers who play active parts at the leading edge
of the pharmaceutical industry.