Regulatory Open Forum

Has anyone found a way to receive updates when changes are made to the IMDRF AE coding annexes?

The IMDRF website is...a bit outdated (trying to be charitable here), and I can't find a way to receive updates. Most sites at least have an RSS feed. Even the "Recent Updates" page doesn't seem to be kept up to date. There is a stakeholder update email list, but it appears to be for events only. I tried contacting them via the email address on the website, but I didn't get a response. 

Now that use of their coding is mandatory, we'd really like to be informed of updates rather than having to check the website frequently. Am I just missing something? Or is anyone aware of a service that provides these updates? 


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Jennifer Cabralda, RAC (US, CAN)
Director, Regulatory Affairs
Richmond, BC, Canada
------------------------------

Hello Jennifer,

This is a really great question that. I know that you are not alone with missing this feature. Currently, to my knowledge, there is no way to get updates via notifications/e-mails/subscriptions to an RSS Feed or any other means. As you pointed out the "IMDRF stakeholder's mailing list" is only "to receive emails from IMDRF regarding upcoming events".

The IMDRF AE WG provides all Annexes in a new common format since edition 4, since the April 2020/July 2020 update published. I believe this new format was also introduced based on stakeholder feedback and this new format definitely helps to improve the usability of the IMDRF Terminology. Also some new fields were added to the spreadsheets that shows information on the Status / Status Description information to Annexes A, E, and G, to indicate major changes. I liked those updates as they provide better transparency and visibility of the changes.

THE WG has also updated the "maintenance page", not sure if you had recognized this. The maintenance of the final IMDRF AE documents / the Annexe will be managed via this dedicated 'Adverse Event Terminology Maintenance' web page.

The maintenance process was now also described in more detail, for example:

"The terminology is always open for Change Requests. The process is outlined in the figure below. The cutoff date for inclusion in the next release is 1 September. The Change Requests will then be reviewed by IMDRF, and the updated terminology and outcome of Change Requests will be published in February."

IMDRF AE WG has also stated that going forward any "proposal of addition/modification/deletion of the terms must be submitted to AE WG by either National Competent Authorities or Stakeholder Organizations, using the Change Request form. No proposal from an individual will be accepted."

Based on that, I think we should expect only updates to the Annexes once per year and the update would be published in February. So, you would only be needing to set a reminder to check at the end of Feb/beginning of March to check for updates, not throughout the entire year.


------------------------------
Markus Poettker
Zug
Switzerland
------------------------------

Original Message:
Sent: 17-Nov-2020 22:15
From: Jennifer Cabralda
Subject: IMDRF coding - updates

Has anyone found a way to receive updates when changes are made to the IMDRF AE coding annexes?

The IMDRF website is...a bit outdated (trying to be charitable here), and I can't find a way to receive updates. Most sites at least have an RSS feed. Even the "Recent Updates" page doesn't seem to be kept up to date. There is a stakeholder update email list, but it appears to be for events only. I tried contacting them via the email address on the website, but I didn't get a response.

Now that use of their coding is mandatory, we'd really like to be informed of updates rather than having to check the website frequently. Am I just missing something? Or is anyone aware of a service that provides these updates?


------------------------------
Jennifer Cabralda, RAC (US, CAN)
Director, Regulatory Affairs
Richmond, BC, Canada
------------------------------

Thank you Markus, that's very helpful! I'll flag for us to check for updates on this schedule. Hopefully that will allow us to catch most, if not all, of the changes. 

Of course it would still be great if IMDRF would add this feature to their website, so it would be possible to get updates on any of their documents...fingers crossed that it happens eventually!

------------------------------
Jennifer Cabralda, RAC (US, CAN)
Director, Regulatory Affairs
Richmond, BC, Canada
------------------------------

Original Message:
Sent: 18-Nov-2020 03:16
From: Markus Poettker
Subject: IMDRF coding - updates

Hello Jennifer,

This is a really great question that. I know that you are not alone with missing this feature. Currently, to my knowledge, there is no way to get updates via notifications/e-mails/subscriptions to an RSS Feed or any other means. As you pointed out the "IMDRF stakeholder's mailing list" is only "to receive emails from IMDRF regarding upcoming events".

The IMDRF AE WG provides all Annexes in a new common format since edition 4, since the April 2020/July 2020 update published. I believe this new format was also introduced based on stakeholder feedback and this new format definitely helps to improve the usability of the IMDRF Terminology. Also some new fields were added to the spreadsheets that shows information on the Status / Status Description information to Annexes A, E, and G, to indicate major changes. I liked those updates as they provide better transparency and visibility of the changes.

THE WG has also updated the "maintenance page", not sure if you had recognized this. The maintenance of the final IMDRF AE documents / the Annexe will be managed via this dedicated 'Adverse Event Terminology Maintenance' web page.

The maintenance process was now also described in more detail, for example:

"The terminology is always open for Change Requests. The process is outlined in the figure below. The cutoff date for inclusion in the next release is 1 September. The Change Requests will then be reviewed by IMDRF, and the updated terminology and outcome of Change Requests will be published in February."

IMDRF AE WG has also stated that going forward any "proposal of addition/modification/deletion of the terms must be submitted to AE WG by either National Competent Authorities or Stakeholder Organizations, using the Change Request form. No proposal from an individual will be accepted."

Based on that, I think we should expect only updates to the Annexes once per year and the update would be published in February. So, you would only be needing to set a reminder to check at the end of Feb/beginning of March to check for updates, not throughout the entire year.


------------------------------
Markus Poettker
Zug
Switzerland

Original Message:
Sent: 17-Nov-2020 22:15
From: Jennifer Cabralda
Subject: IMDRF coding - updates

Has anyone found a way to receive updates when changes are made to the IMDRF AE coding annexes?

The IMDRF website is...a bit outdated (trying to be charitable here), and I can't find a way to receive updates. Most sites at least have an RSS feed. Even the "Recent Updates" page doesn't seem to be kept up to date. There is a stakeholder update email list, but it appears to be for events only. I tried contacting them via the email address on the website, but I didn't get a response.

Now that use of their coding is mandatory, we'd really like to be informed of updates rather than having to check the website frequently. Am I just missing something? Or is anyone aware of a service that provides these updates?


------------------------------
Jennifer Cabralda, RAC (US, CAN)
Director, Regulatory Affairs
Richmond, BC, Canada
------------------------------