EU Regulatory Affairs Introductory Training Course
02.11.2020
- 04.11.2020
09:00-17:00 Uhr
Details
Do you need essential European regulatory affairs knowledge? This online course gives you a compact overview about all important issues. Each day may be booked separately according to your needs! Save your place in our virtual zoom seminar room.
Topics
- 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
Aims and objectives
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.
Who should attend
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.
For more informations see Website FORUM
Dr Christian M Moers Day 1, 2nd November 2020
Host
FORUM Institut für Management GmbH