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138 results

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Official Launch of Iris Version 6 Date: 20. November 2025 Topics: Kodiersysteme Type: News

Please save the date for the launch webinar on January 28, 2026, at either 10:00 CET or 17:00 CET.

Iris version 6 is available for ICD-11 mortality coding Date: 04. November 2025 Topics: Kodiersysteme Type: News

The Iris software has been used for ICD-10 mortality coding for more than 20 years. Now, Iris is also available for ICD-11 mortality coding.

Oxbryta (voxelotor): EMA confirms suspension of sickle cell disease medicine Oxbryta Date: 23. October 2025 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: voxelotor

EMA confirms suspension of sickle cell disease medicine Oxbryta

Information for marketing authorisation holders: Current information on submission for step 3 Date: 23. July 2025 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: various

Information for marketing authorisation holders: Current information on submission for step 3

Radiation applications in combined clinical trials (clinical trials submitted to both CTIS and DMIDS) Date: 14. July 2025 Type: News

For studies with submission in CTIS and DMIDS, only one radiation protection submission is required - depending on the study focus CTIS or DMIDS.

New version of the DMIDS module "Clinical investigations and performance studies" from July 1, 2025 Date: 24. June 2025 Topics: Medical devices Type: News

The BfArM launches a new version of the DMIDS module "Clinical investigations and performance studies" on July 1, 2025.

New radiation protection regulations effective July 1, 2025 Date: 20. June 2025 Type: News

Effective July 1, 2025, new regulations will apply to radiation protection approvals or notifications for clinical trials.

Approval procedure pursuant to Section 31 of the German Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) of 1 July 2025 Date: 20. June 2025 Type: News

The article provides information on the correct procedure for approval procedures in accordance with Section 31 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) in the context of CTR applications and Substantial Modification in CTIS.

Notification procedure pursuant to Section 32 of the German Radiation Protection Act (Strahlenschutzgesetz, StrlSchG) of 1 July 2025 Date: 20. June 2025 Type: News

This article provides information on the correct procedure for reporting a notification procedure in accordance with Section 32 StrlSchG (Strahlenschutzgesetz (German Radiation Protection Act)) as part of CTR submission and for Substantial …

Save the date – next Iris webinar Date: 05. June 2025 Topics: Kodiersysteme Type: News

The next Iris webinar will be held on 9th July 2025.

Iris user survey Date: 17. April 2025 Topics: Kodiersysteme Type: News

The Iris user survey is now available!

Save the date – next Iris webinar Date: 31. March 2025 Topics: Kodiersysteme Type: News

The next Iris webinar will be held on 15th April 2025.

Reminder: Iris user group meeting – register now Date: 26. March 2025 Topics: Kodiersysteme Type: News

The Iris user group meeting will take place on 15th and 16th May 2025 in Cologne.

Iris training: Save the date and register Date: 12. February 2025 Topics: Kodiersysteme Type: News

The Iris training will be held as a web-based training from 31st March until 3rd April 2025.

Save the date – next Iris webinar Date: 24. January 2025 Topics: Kodiersysteme Type: News

The next Iris webinar will be held on 19th February 2025.

Iris user group meeting – save the date and register Date: 22. January 2025 Topics: Kodiersysteme Type: News

The dates and information for the next Iris user group meeting are available.

New version of Iris version 6 is available for testing with ICD-11 Date: 16. December 2024 Topics: Kodiersysteme Type: News

The second test version of Iris version 6 for ICD-11 mortality coding has been released. You will find version 6.0.26 and the Iris Manual under “Downloads” on our website.

Ocaliva: Review of the risk-benefit ratio Date: 09. December 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: obeticholic acid

On 26 November 2024, the General Court dismissed the action for interim measures, which means that the revocation decision for Ocaliva has now taken effect.

Save the date – next Iris webinar Date: 26. November 2024 Topics: Kodiersysteme Type: News

The next Iris webinar will be held on 11th December 2024.

Update of decision tables for Iris version 5 available Date: 28. October 2024 Topics: Kodiersysteme Type: News

We published updates of the decision tables (specV2021SR50Muse). The new decision tables are available in the Iris download area.

Save the date – next Iris webinar Date: 10. October 2024 Topics: Kodiersysteme Type: News

The next Iris webinar will be held on 13th November 2024.

Update of Iris version 5 Date: 09. September 2024 Topics: Kodiersysteme Type: News

We published a new version of the Iris software – V5.8.4-Y2024S2.

Update of Iris version 5 Date: 10. June 2024 Topics: Kodiersysteme Type: News

We published a new version of the Iris software – V5.8.3-Y2024S1.

Pseudoephedrine: Risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) Date: 04. April 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: pseudoephedrine

With the publication of the European Commission's decision, the risk assessment procedure according to Article 31 of Directive 2001/83/EC on medicinal products containing pseudoephedrine has been completed.

Reminder: Iris User Group meeting in April 2024 Date: 07. March 2024 Topics: Kodiersysteme Type: News

The Iris user group meeting will take place at BfArM on 10th and 11th April, 2024 in Bonn.

Contrast agents containing gadolinium: Deposits in the brain and other tissues Date: 16. February 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: gadolinium

For contrast agents containing gadolinium, the suspension of marketing authorisations has been extended until 28 February 2026.

Iris User Group Meeting – Dates have changed Date: 19. January 2024 Topics: Kodiersysteme Type: News

As a result of necessary changes in the planning of meeting rooms the dates of the next Iris user group meeting have changed.

Valproate: Risk of congenital malformations and developmental problems associated with use during pregnancy Date: 12. January 2024 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: valproate

Educational material on medicinal products containing valproate

Iris Meetings – Save the Dates Date: 14. December 2023 Topics: Kodiersysteme Type: News

The dates and information for the next Iris meetings are available.

Hydroxyethyl-starch containing Medicines: Introduction of new measures to protect patients Date: 24. November 2023 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: hydroxyethyl starch

The Federal Institute for Drugs and Medical Devices (BfArM) publishes updated information on marketability.