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
requirement know-how
2018-12-26 2019-06-27 Amsterdam Marriott Hotel Stadhouderskade 12 1054 Amsterdam +31 20 6075555 +31 20 60075511

eSubmission Manager in Europe

eSubmission and database requirements in 2019

The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity for IDMP, SPOR and XEVMPD.
  • eSubmission - Regulatory update
  • XEVMP, 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

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.
Your speaker on both days
Remco Munnik
ASPHALION S.L., Barcelona, Spain

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

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




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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).