Life Sciences

MedDRA Upgrades: 4 Clarifications

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:

  1. 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
  2. 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
  3. The current EMA and FDA guidelines regarding how often you should upgrade your MedDRA dictionary is twice per year; WHO Drug is annual.
  4. There are non-English translations of MedDRA available; check the MSSO site for more information.
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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.

About the Author

Kari Blaho-Owens, Ph.D., received her graduate degree in pharmacology and clinical therapeutics from LSU Medical Center in New Orleans, Louisiana, US. She was the Research Director and clinical toxicologist consultant in an inner-city Emergency Department at UT College of Medicine and has spent much of her career in the life sciences industry working for pharmaceutical and device companies, as well as CROs. She also served as the global head of PV at a major company. Kari is currently the head of PV at Perficient, where she leads a team that implements fit-for-purpose technology solutions and provides pharmacovigilance consulting. She is also a peer reviewer for the DIA.

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