MHLW / PMDA / USP Workshop presentations

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.

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)?


Thank you for sharing, @Naiffer_Host. This was a very impressive workshop. I want others to see second slides presented by Dr. Hirai, he really made a lot of efforts to meet requirements. I guess many participants can take a better way, but it’s his real. It looks so tough. And I want to clarify lots of challenges concerning with nitrosamine impurities and reduce workloads of pharmaceutical companies and others as far as I can.