Find all needed information about Eudravigilance Gateway Support. Below you can see links where you can find everything you want to know about Eudravigilance Gateway Support.
https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance/eudravigilance-training-support
The European Medicines Agency (EMA) offers training to support stakeholders in meeting their pharmacovigilance obligations when using EudraVigilance.Training is important to ensure that users understand its functionalities and submit high quality data which adhere to standards that allow for adequate monitoring of the safety of medicines and the protection of public health in the European ...
http://eudravigilance.ema.europa.eu/veterinary/gateway.html
EudraVigilance Veterinary - Gateway. The Gateway is a separate software package developed by third party IT software companies in accordance with specific requirements and allows the pharmaceutical industry to report to a common reporting point within the EEA from where the transactions are re-routed to the addressed Competent Authorities, and ...
https://eudravigilance.ema.europa.eu/human/evGateway01.asp
The purpose of the EudraVigilance Gateway is to operate a single, common, European Economic Area (EEA)-wide Gateway for receiving regulatory submissions in a fully automated and secure way including all aspects of privacy, authentication, integrity and non-repudiation of all transactions in pharmacovigilance. ... Article 57 and Gateway support ...
https://eudravigilance.ema.europa.eu/human/evGateway04.asp
An integrated component of the EudraVigilance gateway that is made available by the EMA to registered parties that do not have their own ESTRI gateway established, providing a way to securely exchange safety and acknowledgement and medicinal product report messages in a semi-automatic way.
https://www.ema.europa.eu/en/documents/other/eudravigilance-support-guide_en.pdf
EudraVigilance support guide Guidance document on the query support options offered by the EMA on EudraVigilance and Pharmacovigilance related queries . Content Technical or application-specific queries Using the EMA Service Desk Portal Pharmacovigilance-related or general queries
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-evweb-user-manual-version-15_en.pdf
The WEB Trader transmission mode is an integrated component of the EudraVigilance Gateway designed to support Small and Medium Size Enterprises (SMEs) or Regional Pharmacovigilance Centres (RPCs) to generate, send and receive ICSRs in a …
https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance
EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.
http://www.gateway.com/gw/en/US/content/support-overview
Register your Gateway product to gain access to support and product updates. Learn More. Warranty. All Gateway technology is backed by warranty, as detailed in our terms & conditions. Learn More. Contact Support. We make Gateway products simple to use. Then we provide great support.
http://eudravigilance.ema.europa.eu/Decommissioned/Decommissioned.html
New EudraVigilance website Announcement to EudraVigilance website users The public information on this website has been incorporated into the European Medicines Agency corporate website. The public pages of the current EudraVigilance website have been decommissioned, but Registered EudraVigilance users will continue to access the restricted area as usual.
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