Last June 16-17 MHLW/PMDA and USP hosted workshop ‘Role of Quality in Pharmaceuticals’.
We had a dedicated track on Mutagenic Impurities including Nitrosamines.
Dr. Kazusei Komatsu from Shionogi presented the current situation and case study of ICH M7 at a Japanese Company - https://www.pmda.go.jp/files/000241926.pdf
Dr. Yasuo Hirai from Daito Pharmaceutical presented current comprehensive approach for control of Nitrosamine Impurities in Japan - https://www.pmda.go.jp/files/000241927.pdf
Dr. JuJunichi Fukuchi from PMDA introduced control of organic impurities in marketed products in Japan - Current status and perspectives - https://www.pmda.go.jp/files/000241928.pdf
Dr. Masahiro Uchino from PMDA presented a case study on the control of Nitrosamine impurities in Sartan drugs - https://www.pmda.go.jp/files/000241930.pdf
Any particular interest of our community in hosting PMDA for a candid discussion. What would be you ask (other than when is the guide coming out)?