Digital Systems for eCTD Creation on the Pharmaceutical Market of the Eurasian Economic Union

P. 379–389.

Koshechkin K., Lebedev G., Zykov S. V.

Pharmaceutical market integration is highly dependent on digital technologies
in general and the Internet in particular. The work aims are to study the
available software for creating Electronic common technical documents and the
possibility of its application on the Eurasian Economic Unionmarket.To obtain information,
the surveywas performed based on employees of pharmaceutical companies,
which were interviewed to identify the software they are using or plan to use. Based
on the obtained results, a list of preferred software was compiled. It contains 9 software
products. As part of the second phase of the study, a survey of developers
of designated software solutions was conducted. Results showed that for pharmaceutical
companies operating in the Eurasian Economic Union region, the issue of
software readiness for working with the requirements of domestic regulators is of
particular importance. Most foreign software products can be localized only after
significant modifications. Domestic software solutions are just beginning to appear
and in some cases are highly specialized. For example, programs for planning and
meeting regulatory deadlines in the market are represented by single products.

Keywords: pharmaceutical market, программная система, Software System, фармацевтические рынки, нормативные технические требования, dossier requirements

In book

Intelligent Decision Technologies. Proceedings of the 12th KES International Conference on Intelligent Decision Technologies (KES-IDT 2020)

Vol. 193. , Singapore: Springer, 2020.