Bfarm/EMA discussion with vendors & industry on eCTD

By 10. October 2017Blog

On 6th of October 2017, software vendors providing eCTD solutions have been invited from Bfarm to sit together and discuss about the upcoming next major version eCTD version 4.0. In addition the industry as well as members of the CMB maintenance and ICH expert working groups were participating the discussion, too. The purpose of this meeting was based on the EU Implementation Guide. Vendors used this opportunity to ask questions and give feedback to the current given EU implementation approach. The major topics which have been addressed were related to the physical folder structure of eCTD 4.0, suggestions on simplifying the 4.0 xml message as well as process related discussions around Transitional Mapping Message, Controlled Vocabularies and 2-way-communication.


Author Daniel Koppers

Cunesoft CTO, He has more than 7 years experience with software development and project management. Moreover, he has a deep knowledge of life sciences and regulated industries. His previous employers include Nextdocs and Adlib Software. He has a degree in business informatics.

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