Variations Conference

Veranstaltungs-Beschreibung

You have been working under the Variations Regulation for two years now. The legislation process is moving on to also include variations to purely national marketing authorisations to the regulation.

We would like to give you a thorough update on the procedures and the classification of variations as well as to inform you on the upcoming changes due to the pharma package, the electronic submission of the product information at the EMA etc.

Day one focuses on the procedures, the grouping options and also addresses the variation submission in the eCTD format.

Day two focuses on quality related variations and addresses in addition to typical cases of quality related changes new regulatory duties as post approval change management protocols.

May we invite you to take this opportunity to discuss your questions with experts from various national agencies and the industry?