We like to share our knowledge. Due to our long-time experience we impart implementable skills as well as the underlying theoretical knowledge.
|❖||Introduction in the Swiss authorisation procedures, focus can be chosen individually as needed (formal requirements, new applications, article 13 procedures, generics, variations, labelling, etc.). Hands-on exercises will be included as agreed / needed. Introduction is selectable for regulatory managers as well as for assistance personnel.|
|❖||Refreshment of particular regulatory topics.|
|❖||Pharmacovigilance training, for pharmacovigilance responsible persons as well as for other personnel that has to provide training records.|
|❖||eCTD: basic training for eCTD starters, the training program can be individually agreed upon requirements and either be a complete training including compilation, validation and publishing of sequences or focusing on specific tasks. Of course, focus will be on hands-on exercises.|