It is considered a hub and the connections for the companies, sponsors and national competent authorities in the EEA are known as spokes. The EV Gateway is providing a single point of contact between companies and sponsors as well as national competent authorities in the EEA. complies with international standards and open technology solutions.reduces the paper processing burden/cost for national competent authorities, companies and sponsors in the EEA.accelerates the communication for expedited safety reporting.standardises secure data transmission between us, national competent authorities, companies and sponsors in the EEA.What are the advantages of the EV Gateway? ![]() Companies and sponsors are responsible for implementing at least one of the multiple ESTRI standards in order to ensure electronic communication with any regulatory authority. The EV Gateway follows the ICH M2 Gateway Recommendation for the Electronic Transfer of Regulatory Information (ESTRI-Gateway). It provides national competent authorities with a secure reporting mechanism to companies, sponsors and to us. The EV Gateway allows pharmaceutical companies and sponsors of clinical trials to report to a common reporting point within the European Economic Area (EEA) from where the transactions are re-routed to the addressed national competent authorities and the European Medicines Agency (EMA). ![]() Regulatory submissions can be sent and received in a fully automated and secure way, including all aspects of privacy, authentication, integrity and non-repudiation of all transactions in pharmacovigilance. ![]() The EudraVigilance (EV) Gateway is a single, common electronic regulatory submission environment.
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