FORUM INSTITUT
FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Email: service@forum-institut.de
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 amsterdam@marriott.com +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.
Topics
  • 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

This distinguishes our event

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


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Our international course portfolio

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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).

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