The holder of this certificate has attended the course "Completing the Quality/CMC Module of the CTD".

This training course examines the FDA and EMA regulatory requirements for both pharmaceuticals and biotech. It will give you the confidence to identify, compile and submit the correct information in the quality module. Once completed you will have a comprehensive understanding of key areas such as CMC regulatory strategy, building the pharmaceutical sections, creating the drug product sections, and creating the Quality Overall Summary (QOS).