CMC Documents: Scientific Writing for Regulatory Submission - Update your CMC English writing skills - with many practical exercises!

Our seminar will provide you with practical tools to help you become more comfortable writing the CTD's CMC documents.

After a short update on grammar, English standards and style, you will be better equipped to write Module 3 and the Quality Overall Summary: you will be able to present data clearly and in compliance with the regulations, and you will be able to sew a "golden thread" through your CMC documents.

In addition, English writing skills will be a part of your repertoire, enabling you to deal with the difficulties posed by the English language to both native and non-native speakers. Having applied your writing skills to practical exercises, you will be able to write the drug substance as well
as the drug product sections using sophisticated English.

Last but not least you will learn to cross-check the CMC documents prior to submission and to avoid questions from Health Authorities.