EU Regulatory Affairs introductory training course
- Online training -
Day 1: 9 - 17
Day 2: 9 - 17
Day 3: 9 - 17
Do you need essential European regulatory affairs knowledge? This online training course gives you a compact overview on all important issues. The training course will be entirely held in English.
- 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 lifecycle management: Variations, renewals, eCTD and electronic submission
Wer sollte teilnehmen?
This seminar will be of benefit to all those working in regulatory affairs or in related departments that need essential European regulatory affairs expertise. Basic pharmaceutical knowledge is recommended but not prerequisite.
Ziel der Veranstaltung
This online 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 lifecycle management for a product and the structure and submission of an electronic dossier.
- You will get to know the basic principles for MA procedures in Europe
- You will learn about the different procedures in deatil
- You will know what to have in mind for SmPC and the package leaflet
- You will learn abotu the different modules of the dossier
- You will get to knoe the Variation system and procedures
- You will get to know all you need about the electronic submission
- You will learn with many practical examples
FORUM Institut für Management GmbH