EU Regulatory Affairs Introductory Training Course - Webinar von FORUM Institut für Management GmbH

- 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 submissionDo 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.

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.- Book day 1, day 1 and 2 or all three days, according to your needs! A preparatory e-Learning is included in your booking.

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.