Nitrosamines webinar – what would you be interested in?

Dear TOPRA Colleagues,

CMC SPIN is going to organise a webinar on Nitrosamines in pharmaceuticals planned for September 2021.

We would like to learn if there is interest from CMC community and hear from you about the topics you would like to discuss. Please also share with us any doubts or questions you may have! Do let us know by adding a comment to this Topic.

We really appreciate your feedback.

Wish you All a great day!

Best regards,

Michal Mista
TOPRA CMC SPIN

6 Likes

CMC are very interested in this topic. Mostly not in aspect of importance of topic, but how to write Risk assessment. Which information should be included, which data could confirm the absence of Nitrosamine in API, FP, etc.

4 Likes

So, will I. Thanks

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Thus ist really a hot topic, much appeciated. I agreed with Svetlana on topics; maybe also wΓ€re to place it in CTD Module 3 (3.2.p.5.6 or 3.2.p.2)