FORUM INSTITUT
FORUM · Institut für Management GmbH
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69115 Heidelberg
Email: service@forum-institut.de
Phone: +49 6221 500-500
Fax: +49 6221 500-505
Course eSubmission Manager in Europe
eSubmission Manager in Europe
eSubmission and database requirements in 2019
2018-12-26 2019-06-27 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 2019

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

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.
Speakers
Your speaker Day 1
Remco Munnik
ASPHALION S.L., Barcelona, Spain

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


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