Messages in brief
Introduction to Organisation Management Service (OMS) / Referentials Management Service (RMS) services and activities: Industry webinar Share – 21.10.2021
messages in brief
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11/10/2021
This webinar is an introduction to Organisation Management Service (OMS) and Referentials Management Service (RMS) services and activities for industry users.
Introduction to Organisation Management Service (OMS) / Referentials Management Service (RMS) services and activities: Industry webinar Share – 21.10.2021
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Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS) – 29.11.2021
messages in brief
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06/10/2021
This event aims to inform SMEs and academic sponsors of clinical trials on how to prepare for the main changes brought by the Regulation and its impact on their trial-related activities.
Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS) – 29.11.2021
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Clinical Trials Information System (CTIS): Virtual information day – 26.10.2021
messages in brief
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06/10/2021
The aim of this event is to help future CTIS users prepare for submitting and evaluating clinical trial applications in CTIS after its go-live on 31 January 2022.
Clinical Trials Information System (CTIS): Virtual information day – 26.10.2021
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Current issue of “RMS NEWS”
messages in brief
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30/09/2021
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Current issue of “RMS NEWS”
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Shelf-life of Comirnaty extended
messages in brief
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20/09/2021
The Product Information has been updated with the new shelf-life for the frozen vial, that has been extended from 6 months to 9 months. The storage conditions remain unchanged (-90 °C to -60 °C).
Shelf-life of Comirnaty extended
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SARS-CoV-2 rapid antigen test registry
messages in brief
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19/07/2021
The registry lists in a new form - with search and filter options - those SARS-CoV-2 rapid antigen tests that can be placed on the Austrian market for self-testing.
SARS-CoV-2 rapid antigen test registry
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CHMP Meeting Highlights June 2021
CHMP Monthly News
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07/07/2021
Up-to-date information from the June 21-24 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
CHMP Meeting Highlights June 2021
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Current issue of “RMS NEWS”
messages in brief
|
30/06/2021
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Current issue of “RMS NEWS”
Read more
CHMP Meeting Highlights May 2021
CHMP Monthly News
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17/06/2021
Up-to-date information from the May 17-20 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
CHMP Meeting Highlights May 2021
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Comirnaty (COVID-19-mRNA-Vaccine)
messages in brief
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02/06/2021
On May 28, 2021, the use "for active immunization of individuals 12 years of age and older" was extended by the EMA.
Comirnaty (COVID-19-mRNA-Vaccine)
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