Agenda | CPhI Japan

Join pharma leaders at CPhI Japan 2017

Take advantage of CPhI Japan's innovative, interactive and educational programmes to network, learn and gain new insights to the world of pharma. 

Seminars and Conferences

With the market opening up to foreign players, now is the time to get valuable insights into the Japanese pharma market regulations and trends. Every year CPhI Japan hosts a wide range of free seminars and conferences from the government, industry associations and other key players. Attending the seminars and conferences will give you a competitive advantage - helping you drive business successfully in the world's 3rd largest pharma market.

Over 9,000 pharma professionals attend these sessions every year. All seminar rooms are located on the exhibition floor ensuring easy entrance from seminars to the exhibition floor and vice versa.

IMPORTANT: Registration is required to attend the conferences seminars free of charge. Don’t wait too long, reserve your seat now! Click on the button for the full schedule and registration.

View below a glimpse of (keynote) seminars in English or English interpretation.

Keynote seminars - by the Japanese Ministry of Health, Labour and Welfare

K-1: Current topics regarding regulation of pharmaceuticals in Japan

19 April 2017 | 9:15 - 10:30【Language: English/Japanese】

Mr. Masanobu Yamada
Director, Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau
Ministry of Health, Labour and Welfare

This seminar introduces topics regarding regulations of the Japanese pharmaceutical market. It will discuss and provide a guideline for the ‘SAKIGAKE Designation System’, which promotes R&D in Japan aiming at early practical application for innovative pharmaceutical products, medical devices, and regenerative medicines. Additionally, the engagement with international harmonization of regulation in Japan will be introduced, based on regulatory science initiative

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K-6: Current situations and challenges of policy on health insurance ~ review of current pricing and reimbursement system on medicines etc ~

20 April 2017 | 9:30 - 10:30 【Language: English/Japanese】

Mr. Katsufumi Jo,
Director, General Affairs Division, Health Insurance Bureau,
Ministry of Health, Labour and Welfare

Last year, we decided to review the current pricing and reimbursement system of medicines. In this review, we will consider, for example, annual pricing review and health technology assessment (HTA) in terms of balancing access to innovative medicines and financial sustainability of universal health insurance system. Including this topic, I would like to explain recent trend and future challenges of policy on health insurance.

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Seminars - by the Japan Pharmaceutical Traders’ Association

K-8: The Collaboration between China and Japan in Health Area and Chinese Regulation Update

20 April 2017 | 12:45-13:45 【Language:English/Chinese/Japanese】

【Organised by; Japan Pharmaceutical Traders’ Association, China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) 】

Ms. Meng Dongping
Vice President
China Chamber of Commerce for Import & Export of Medicines & Health Products

Chinese API manufacturers are becoming increasingly important to Japan’s pharmaceutical industry with the growing use of generic pharmaceuticals in Japan. Besides, China is transforming from exporting to importing, more and more Chinese companies also want to import products from Japan. So it is very important for both manufacturers and pharma professionals to fully understand each other’s regulation and requirement. This seminar, featuring a representative from the China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE), will provide you with an opportunity to learn about Chinese healthcare industry and regulations update including revisement of pharmaceutical affair law, MAH system, GMP, bound evaluation and generics quality consistency evaluation. She also will refer to bilateral cooperation status between China and Japan in healthcare area and how to promote and move the collaboration forward.

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K-9: How we should address data integrity?

20 April 2017 | 14:15-15:15 【Language:English/Chinese/Japanese】

【Organised by; Japan Pharmaceutical Traders’ Association】

Mr. Kazuhito Takahashi
President
Pharma planning Co., Ltd.

"Data integrity" is the fundamental and a big concern in the global pharmaceutical industry.
FDA announced that they had increasingly observed CGMP violations involving data integrity during cGMP inspections. Many Waring Letters have involved data integrity lapses in drug manufacturing.
MHRA and WHO published their guidelines in 2015, PIC/S and FDA published new draft guidance in 2016.
Pharmaceutical industries need to meet requirements about data integrity strict with those guidelines or guidance. We will discuss how to address data integrity based on guidelines/guidance and some Waring Letters.

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K-10: Q11, Practical Aspects of Implementation- an Industry Perspective

20 April 2017 | 15:45-17:00 【Language:English/Chinese/Japanese】

【Organised by; Japan Pharmaceutical Traders’ Association, Active Pharmaceutical Ingredients Committee (APIC-CEFIC)】

APIC – CEFIC
Ms.  Marieke van Dalen
Global Regulatory Specialist, Aspen Oss B.V.

Many of Japanese API manufacturers still have some confusion over how to understand the ICH Q11 guidelines and complete the requirements on a practical basis since they were finalized for the development and manufacture of drug substances in 2014. In this seminar session, which is aimed at facilitating the implementation of Q11 in Japan, representatives from the Active Pharmaceutical Ingredients Committee (APIC) of the European Chemical Industries Council (CEFIC) and the Japan Pharmaceutical Traders Association (JPTA) will introduce practical cases about how API manufacturers have understood the guideline and implemented it in their businesses.

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There are many other international seminars, including seminars from India, Taiwan and Europe which will be held in English or with English interpretation.