Regulatory Open Forum

Original Message------

I am looking for information on the Japanese requirements for screening and testing donors of cellular products that will be used for further manufacture into immunotherapy related biologics.

Hi Ann,

Please check out slides 13-19 in this presentation published by PMDA    https://www.pmda.go.jp/files/000206118.pdf.

Hope this helps. 

Kavita

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[Kavita M Gupta, PhD
Biomedical Consultant
Lethbridge, Alberta

kavita.gupta.narra@gmail.com
403-360-1409

https://www.linkedin.com/in/kavitamadanlalgupta
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Original Message:
Sent: 16-Jun-2017 18:00
From: Ann Kemp
Subject: Cellular therapy Regulations in Japan

I am looking for information on the Japanese requirements for screening and testing donors of cellular products that will be used for further manufacture into immunotherapy related biologics.