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Harmonised standard terms for medicine/pharmaceuticals
מפרסם התגובה: Emily Scott
Emily Scott
Emily Scott  Identity Verified
הממלכה המאוחדת
Local time: 22:39
חבר (2018)
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Oct 8, 2018

Hi everyone,

I'm currently building my resources for translating medical/pharmaceutical texts and was wondering if anyone had any idea where I could find harmonised standard terms (i.e. standard terms across several languages)? So far I have only found the EDQM which seems to provide standard terms on packaging and labelling wording but I was hoping to find somewhere that provides standard terms for medical conditions, adverse reactions etc.
 
Titia Meesters (X)
Titia Meesters (X)  Identity Verified
Local time: 23:39
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MedDRA preferred terms Oct 9, 2018

Hi Emily,
for AEs, EMA uses MedDRA terms (Medical Dictionary For Regulatory Activities), see: https://spor.ema.europa.eu/rmswi/#/search.
Here you can find most AEs in many EU languages, including French and Italian, and EMA requires that you use the MedDRA terms if available.
Good luck!
 
Emily Scott
Emily Scott  Identity Verified
הממלכה המאוחדת
Local time: 22:39
חבר (2018)
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TOPIC STARTER
Thanks! Oct 9, 2018

Hi Titia,

Thank you! Yes, I found this yesterday, I think it was something that you'd actually posted that I saw when trawling through old forum posts I used MedDRA in my old job and was thinking I was going to have to pay to take the exam again so thank you for this information - very useful
 
Joao Figueroa
Joao Figueroa  Identity Verified
צ'ילי
Local time: 17:39
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How to get access? Dec 5, 2018

Hello Titia and Emily!

Could you please help me. I have created an account in the SPOR website but I can't access any content.

It says "You don't have permission to perform this action" when I try to access to "referentials"

Do you know what should I do? I'm translating content related to Clinical trials from English to Spanish and I really need access to the list of Prefered terms for Adverse events.

Thank you!

Joao
 
Emily Scott
Emily Scott  Identity Verified
הממלכה המאוחדת
Local time: 22:39
חבר (2018)
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TOPIC STARTER
Sorry! Dec 6, 2018

Hi Joao,

I'm sorry, I don't know how to fix your issue! Is there a support email address you can contact?
 


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Harmonised standard terms for medicine/pharmaceuticals







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