FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Phone: +49 6221 500-500
Fax: +49 6221 500-505
Course EU Regulatory Affairs Introduction
Marketing authorisation
in Europe for beginners
2018-12-25 2019-11-27 DoubleTree by Hilton Amsterdam Centraal Station Oosterdokstraat 4 1011 Amsterdam +31 20 5300800 +31 20 5300801

EU Regulatory Affairs Introductory Training Course

Marketing authorisation in Europe for beginners

Do 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!
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

This distinguishes our event

Overall impression: 86% of the participants’ feedback was very good or good. (November 2018)
Course content: 86% of the participants’ feedback was very good or good. (November 2018)
Practical benefit: 86% of the participants’ feedback was very good or good. (November 2018)
86% of the participants say that the course met their expectations. (November 2018)

EU Regulatory Affairs Introduction Course

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.
Your speakers
Lidia Cánovas
ASPHALION S.L., Barcelona, Spain

Kora Doorduyn-van der Stoep
Medicines Evaluation Board MEB), Utrecht, The Netherlands

Dr. Christian M. Moers
Sträter Lawyers, Bonn, Germany

Remco Munnik
Iperion Life Sciences Consultancy, Vlijmen, The Netherlands

Jan-Jaap Scherpbier, MSc
Garden State Pharmatech, Arnhem, The Netherlands

Cristina Elena Stanca
Pharmedd Services Ltd., London, Great Britain

Aimad Torqui
MSD Netherlands, Oss, Netherlands

Go forward

Our international course portfolio

Are you interested in our international continuous education programme? We provide a variety of specialised courses for the healthcare industry.


Abbreviations, Glossary

List of abbreviations

Many abbreviations for processes, documents and authorities, amongst others, are used in all regulatory areas. We have compiled the most important ones for you. Our list of abbreviations can be freely downloaded here.


More on our quality criteria

Quality guaranteed!

IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards.

An aggregate evaluation of participants' feedback on all FORUM's healthcare training courses (evaluation period from 10.2017 - 09.2018) produced a result of 1.6 (based on a school grading system of 1-6).