What DADI Means for the Pharmaceutical Industry

What DADI Means for the Pharmaceutical Industry

According to EMA's DADI eAF project Q&A (3), the project go-live will be followed by a six-month transition period, during which both the PDF eAF and the web-based form can be used in parallel. An abrupt change Both pharma companies and vendors have been working around the clock to deliver...

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Veröffentlicht in:Pharmaceutical technology Europe 2022-05, Vol.34 (5), p.32-33
1. Verfasser: Rjavec, Renato
Format: Artikel
Sprache:eng
Schlagworte:
Data exchange
Datasets
Information sharing
Pharmaceutical industry
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Zusammenfassung:According to EMA's DADI eAF project Q&A (3), the project go-live will be followed by a six-month transition period, during which both the PDF eAF and the web-based form can be used in parallel. An abrupt change Both pharma companies and vendors have been working around the clock to deliver against the previously communicated plans, based on EU IDMP Implementation Guidance v2.1, only to find that the direction has changed abruptly with little or no warning. [...]the process for a marketing authorization application submission will not change, says the EMA (4).
ISSN:1753-7967