ASPHALION experts Lidia Cánovas, Vicente Tur and Ramón Hernández Moratinos, together with other four excellent speakers will share their in-depth knowledge with you and will provide you with practical tips on the requirements for new and existing approvals in Europe.
The online training course will cover the following topics:
• The legal basis for drug approval
• Marketing authorisation procedures in Europe in detail
• Variation management and other duties after the approval
• Electronic lifecycle management
AIMS AND OBJECTIVES:
This online training course will inform you about all the important obligations and challenges in regulatory affairs. You will learn about the different procedures in Europe and about the duties after a successful marketing authorisation (MA). Moreover, you will gain practical knowledge about the variation management and the structure and submission of an electronic dossier.