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ectd
electronic common technical document
Last Update: 2014-11-25
Usage Frequency: 4
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ectd:
activities
Last Update: 2011-10-23
Usage Frequency: 1
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life sciences, spl, ectd
life sciences, spl, ectd
Last Update: 2018-02-13
Usage Frequency: 1
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pim und ectd; siamed; system für elektronisches dokumentenmanagement
pim and the ectd; siamed; electronic document management system
Last Update: 2012-04-10
Usage Frequency: 2
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das ectd ist ein austauschstandard für die einreichung von informationen zur unterstützung eines antrags auf genehmigung für das inverkehrbringen.
the ectd is an exchange standard for the submission of information in support of a marketing authorisation application, whose specification was signed off at step 4 in the ich process in september 2002.
Last Update: 2011-10-23
Usage Frequency: 1
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er trug als mitglied der delegation der europäischen gemeinschaft in der sachverständigenarbeitsgruppe m2 der ich zur entwicklung des ectd bei und leistete technische unterstützung bei der erprobung des ectd mitte 2001.
the priorities, which were set after consultation with stakeholders in the european regulatory system, are communication, pan- 36 emea annual report 2001
Last Update: 2012-04-10
Usage Frequency: 2
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das ectd wird im rahmen dieses prozesses von der sachverständigenarbeitsgruppe m2 „ elektronische standards für die Übertragung zulassungsrechtlicher informationen“ entwickelt.
electronic submission two projects were run in parallel in the area of electronic submissions: the definition of the electronic common technical document (ectd) and the product information management (pim) project. • the ectd defines a harmonised format (but not harmonised content) for the electronic submission of marketing authorisation applications in the european union, japan and
Last Update: 2011-10-23
Usage Frequency: 1
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besonderes augenmerk gilt der entwicklung des elektronischen common technical document (ectd) und der beteiligung an neuen initiativen zur pharmakovigilanz und zur gentherapie.
particular efforts will be made towards the development of the electronic common technical document (ectd) and participation in new initiatives on pharmacovigilance and gene therapy.
Last Update: 2012-04-10
Usage Frequency: 3
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das austauschformat wird nun in drei regionen eingeführt, was für die europäischen zulassungsbehörden bedeutet, ein system für erhalt, validierung, speicherung und bereitstellung von einreichungen im ectd- format zu errichten.
pim is a joint project with efpia dealing with the electronic interchange of information that is included in the summary of
Last Update: 2011-10-23
Usage Frequency: 1
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