インファーマ ジャパン([国際]医薬品原料 展) セミナー 2020


プロセス開発、原薬調達をはじめ、PIC/S、GDPガイドライン、連続生産、バイオ医薬品など注目テーマが目白押し!

Special Session

PI-S1 November 25 (Wed) 10:30  -  11:30
  • FREE / Pre-registration Required

As a Good Partner of Commissioned Company for a Small Amount of Active Pharmaceutical Ingredients

  • Available only in Japanese
Ryotaro Katsura President, Katsura Chemical Co., Ltd.

Detail & Speaker’s Profile

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What is the critical points for acting as a good API partner in drug development stage?We introduce our business policy and activity considering our new containment facilities.

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PI-S2 November 25 (Wed) 13:00  -  14:00
  • FREE / Pre-registration Required

Raw Materials for Pharmaceuticals: International Procurement and Stable Supply

  • Available only in Japanese
Hideo Tsunoda President, Shin Nippon Yakugyo Co., Ltd. / President, Central Chemical Co., Ltd.

Detail & Speaker’s Profile

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Japan has rapidly increased importation of APIs with the increased use of generic medicines. We are going to provide the latest information on their APIs supply chains how they have been affected by the COVID-19 in addition to the current global tensions and what kind of responses are needed to keep stable supply, what kind of situations are in major exporting countries like China, India, Korea and EU by way of our and industry networks.We will show what are the possible causes of the problems and propose their solution plans in order to avoid similar perils in future for the pharmaceutical industry which now depends 70 to 80% on the imported APIs and other primary materials for our domestic use. It is expected that both the industry and regulatory authorities would proactively prepare for the future.

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Tamotsu Fujino Former Advisor for International Affairs and Publicity, Japan Pharmaceutical Traders' Association

Detail & Speaker’s Profile

<Detail>
Japan has rapidly increased importation of APIs with the increased use of generic medicines. We are going to provide the latest information on their APIs supply chains how they have been affected by the COVID-19 in addition to the current global tensions and what kind of responses are needed to keep stable supply, what kind of situations are in major exporting countries like China, India, Korea and EU by way of our and industry networks.We will show what are the possible causes of the problems and propose their solution plans in order to avoid similar perils in future for the pharmaceutical industry which now depends 70 to 80% on the imported APIs and other primary materials for our domestic use. It is expected that both the industry and regulatory authorities would proactively prepare for the future.

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PI-S3 November 25 (Wed) 15:30  -  16:30
  • FREE / Pre-registration Required

Pharmaceutical Development: Current Situation and Future of Process Chemistry

  • Available only in Japanese
Yasunori Aoyama, Ph.D. Vice President, API R&D Lab., CMC R&D Div., Shionogi & Co., Ltd.

Detail & Speaker’s Profile

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Recent drastic environmental changes surrounding drug development make a major impact on a role, importance and required level of process chemistry. In this lecture, I would like to talk about the current status and future outlook of process chemistry with some examples in Shionogi.

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PI-S4 November 26 (Thu) 10:30  -  11:30
  • FREE / Pre-registration Required

Process Development for Biopharmaceuticals

  • Available only in Japanese
Mareto Hosono, Ph.D. Senior Manager, Process Development, Bio Process Research and Development Labs., Production Div., Kyowa Kirin Co., Ltd.

Detail & Speaker’s Profile

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Currently, there has been a strong demand for higher efficiency and lower cost in biopharmaceutical processes, and new efforts and improvements are always required. I will provide recent trends, new technology developments, challenges and approaches in biopharmaceutical process development mainly for monoclonal antibody products.

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PI-S5 November 26 (Thu) 13:00  -  14:00
  • FREE / Pre-registration Required
  • Available only in Japanese
Atsushi Nakamura Director, Manufacturing & Technology Dept., Takahagi Technology Center, Astellas Pharma Tech Co., Ltd.

Detail & Speaker’s Profile

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API manufacturing process development by chemical synthesis is explained using some trouble cases of scale up experiments and example of commercial API manufacturing from chemical engineering point of view. And I introduce control strategy of genotoxic impurities and equipment cleaning as Quality by Design.

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Concurrent Conferences Pre-registration Required

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