FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Phone: +49 6221 500-500
Fax: +49 6221 500-505
Course eSubmission Manager in Europe
eCTD specification and
eSubmission requirements
2019-12-18 2020-05-19 Amsterdam Marriott Hotel Stadhouderskade 12 1054 Amsterdam +31 20 6075555 +31 20 60075511

eSubmission Manager in Europe

eSubmission and database requirements in 2020

The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD.
  • eSubmission - Regulatory update
  • XEVMPD, IDMP, SPOR: Efficient data maintenance and integrity
  • Regulatory information management
  • eSubmission and the various purely national requirements in Europe
  • IT know-how for eSubmission managers

This distinguishes our event

Overall impression: 100% of the participants’ feedback was very good or good. (June 2019)
Course content: 100% of the participants’ feedback was very good or good. (June 2019)

Aims and objectives

This seminar will familiarise you with electronic submission requirements in regulatory affairs and enable you to further professionalise your submission management. It will also identify the data you need for IDMP and SPOR and show you how to optimise your data integrity management.
Who should attend
This seminar is aimed at all specialists and managers entrusted with the electronic submission of marketing-authorisation-related documents or responsible for the regulatory databases.
Basic eCTD knowledge is advantageous.
Your speakers
Your speaker on both days
Remco Munnik
Iperion Life Sciences Consultancy, Vlijmen, The Netherlands

Your speaker day 2
Sven Harmsen
e-DRA Harmsen - a service provider for electronic drug regulatory affairs, Munich, Germany

Go forward

Find out more on our international portfolio

Our international course portfolio

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




Hear from our past delegates and sponsors and learn more about the events.


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 01.2019 - 12.2019) produced a result of 1.6 (where 1 is the highest grade and 6 the lowest).