Documentation

/Tag: Documentation

All applications must be in eCTD format as of 1 October 2019

Within a very short deadline paper submissions will no longer be accepted by the Danish Medicines Agency. All applications must be in eCTD format as of 1 October 2019. By Susanne Felumb Paper-based submissions will [...]

All applications must be in eCTD format as of 1 October 20192019-08-19T08:24:53+00:00

Good practice for documentation of safety variations

How to ensure good practices for documentation of safety variations By Ea Dige Ensuring good practices for documentation and management of safety variations, starts by optimizing the cooperation between your Regulatory Affairs (RA) and Pharmacovigilance (PV) functions. [...]

Good practice for documentation of safety variations2018-09-17T10:54:01+00:00