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.