Dzeparoski, Marjan (2023) eSubmissions in non-EU Countries. In: Lorenz Connect 23, 16-17 May 2023, virtual. (Unpublished)
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Abstract
In presentation will be discussed about eSubmissions of medicines and medical devices, becoming mandatory for all types of Applications. Regional regulatory aspects are moving towards global electronic submissions/eCTD. This presentation will give a detailed overview of current and planned submission formats in Serbia, Montenegro, Albania, Bosnia, Kosovo and Macedonia, as well as in United Arab Emirates. Regional National Agencies have developed customized-softwares for electronic submissions, but also documents in NeeS and eCTD format can be used for eSubmissions. Get an indepth look at regulation compliance from the emerging markets and steps to keep up to date on global products within country-specific environments.
| Item Type: | Conference or Workshop Item (Lecture) |
|---|---|
| Subjects: | Medical and Health Sciences > Health sciences |
| Divisions: | Faculty of Medical Science |
| Depositing User: | Marjan Dzeparoski |
| Date Deposited: | 14 Jun 2023 08:46 |
| Last Modified: | 14 Jun 2023 08:46 |
| URI: | https://eprints.ugd.edu.mk/id/eprint/31884 |
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