Gefragt von: Joe Cesarano
Fragesteller Allgemeines

Iris Portal Ema

Der Link der Iris Portal Ema-Seite ist unten angegeben. Seiten, die sich auf Iris Portal Ema beziehen, werden ebenfalls aufgelistet.

Zuletzt aktualisiert: 2022-02-02

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Added by: Ainsley Mummery

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Home · IRIS

The Iris, or “Blue Flag”, is a plant used in healing and medicine since ancient times. In Greek mythology, Iris was a messenger to the Gods who carried the “Caduceus”, or staff, now found at the centre of the international symbol for medicine. The IRIS platform facilitates the exchange of regulatory and scientific information between EMA and organisations developing medicinal …
Url: https://iris.ema.europa.eu/
Home · IRIS

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Home · IRIS

To sign in to IRIS you need an active EMA user account with the necessary user access roles. You can create a new user account, apply for user access roles, reset ...
Url: https://iris.ema.europa.eu/SignIn?returnUrl=%2F
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Home - access · IRIS

To use IRIS as a logged-in user to submit your application, you need to complete a few registration steps. A quick interactive guide to the IRIS registration process provides you with a summary of actions to ensure that: You have an active EMA account Your organisation is registered in EMA's Organization Management Service (OMS) You have the appropriate user …
Url: https://iris.ema.europa.eu/access/
Home - access · IRIS

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List of substances · IRIS

These substances can therefore be used for any IRIS submission, for example to request a new Research Product Identifier (RPI). If you do not find the substance you need, please register it by completing the “ Substance Request Form ” and raising a request via the EMA Service Desk portal, for the substance to be included in the SMS database, attaching the Substance Request Form.
Url: https://iris.ema.europa.eu/substances/
List of substances · IRIS

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EMA Inspections GMP is available on IRIS portal from 21 ...

21.09.2021 · EMA Inspections GMP is available on IRIS portal from 21 September 2021. We are pleased to inform you that the EMA coordinated GMP Inspections feature has been added to the IRIS platform today, 21 September 2021. With the implementation of this new feature, Marketing Authorisation Applicants/Holders as well as EU/EEA inspectorates will be able ...
Url: https://iris.ema.europa.eu/forums/whats-new/faf81386-ee1a-ec11-b76a-0003ff4a48b7
EMA Inspections GMP is available on IRIS portal from 21 ...

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IRIS guide for applicants - Europa

EMA Account and appropriate role: for any type of submission in IRIS, you need an EMA account and an appropriate role in IRIS, to login into IRIS. Registration needs to be done only once and will allow you to submit any type of scientific applications now …
Url: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-applicants_en.pdf
IRIS guide for applicants - Europa

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Registration to IRIS training

Registration to IRIS training

Added by: European Medicines Agency

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EMA Account Management: New Self Registration and External User Administrator

EMA Account Management: New Self Registration and External User Administrator

Added by: European Medicines Agency

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1.Overview of the EMA and the centralised procedure

1.Overview of the EMA and the centralised procedure

Added by: European Medicines Agency

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i-SPOC Registration

i-SPOC Registration

Added by: European Medicines Agency

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A demonstration of the EMA's eSubmission Web Client

A demonstration of the EMA's eSubmission Web Client

Added by: European Medicines Agency

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How to check the authenticity of electronic certificates issued by the European Medicines Agency

How to check the authenticity of electronic certificates issued by the European Medicines Agency

Added by: APsystems Solar

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EMA Manager App: Local Commissioning Tool

EMA Manager App: Local Commissioning Tool

Added by: European Medicines Agency

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Online Training

Online Training

Added by: European Medicines Agency

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EMA IRIS Inspections Industry training on GMP & GCP

EMA IRIS Inspections Industry training on GMP & GCP

Added by: European Medicines Agency

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How to submit scientific advice human applications using IRIS

How to submit scientific advice human applications using IRIS
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