EU Regulatory Affairs Introductory Training Course -
von FORUM Institut für Management GmbH
Marketing authorisation in Europe for beginners
- Day 1: Marketing Authorisation Procedures in EuropeLegal basis, Mutual recognition, decentralised and centralised procedure in detail - Day 2: Marketing Authorisation DocumentsData for the dossier, key elements and structure of the SmPC and the package leaflet - Day 3: Regulatory Life Cycle ManagementVariations, Renewals, eCTD and electronic submissionDo you need essential European regulatory affairs knowledge? This course gives you a compact overview about all important issues. Each day may be booked separately according to your needs!
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.
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.