We are quickly coming up to the go-live of the MedDRA 20.1 dictionary. The new version; maintained by the MSSO was released in September 2017; per regulatory guidance will go live on the first Monday, two months after its release. This version, 20.1 will be live 06Nov2017.
Our clients often have questions about upgrading their MedDRA dictionary, as they relate to their Oracle Argus Safety systems.
A couple of things that are urban legends…and those that are not:
- Your users don’t have to be out of Argus to run the “View Only” upgrade – it can be done quickly and efficiently in the background – but Oracle does have some recommendations
- You do need to take a look at the “view mode” to ensure all cases were re-coded and not inadvertently left out because a case processor left a case open
- The current EMA and FDA guidelines regarding how often you should upgrade your MedDRA dictionary is twice per year; WHO Drug is annual.
- There are non-English translations of MedDRA available; check the MSSO site for more information.
This guide analyzes how artificial intelligence – including machine learning – can be used by pharmaceutical and medical device companies to improve the clinical data review and cleansing process.
When upgrading MedDRA, internal organizations should allow time to review the changes and its impact on internal medical coding and signal detection.
Specifics on timing for going live should coincide with the first Monday, two months after the dictionary has been released. The following are helpful links:
As a reminder, the English version of MedDRA is realized twice a year – March 1 and September 1.
Have questions about MedDRA or need assistance with upgrading? Feel free to reach out to me.
*Indy Ahluwalia, Tammy Howard, and Waseem Syeed also contributed to this blog post.