Training Marketing authorization in EU

Do you need essential European regulatory affairs knowledge?

This introductory 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 data and documents required for successful marketing authorisations. Moreover, you will gain practical knowledge about the regulatory life cycle management for a product and the structure and submission of an electronic dossier.

One of the speakers is Remco Munnik from Iperion, focussing on i.e. eCTD and electronic submissions.

Program EU Regulatory Affairs Introduction Course

Day 1
Marketing Authorisation Procedures in Europe
Legal basis, Mutual recognition, decentralised and centralised procedure in detail

Day 2
Marketing Authorisation Documents
Data for the dossier, key elements and structure of the SmPC and the package leaflet

Day 3
Regulatory Life Cycle Management
Variations, Renewals, eCTD and electronic submission