EMA: News about e-submission of information about medicines Thread poster: Catherine GUILLIAUMET
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Hi,
The article begins this way :
"
The European Medicines Agency is preparing for the implementation of the electronic submission of information on medicines.
This is the first deliverable of the new pharmacovigilance legislation...."
and goes on :
"
Phases of implementation
The Agency is applying a phased approach to support the pharmaceutical industry with the implementation of the electronic submission... See more Hi,
The article begins this way :
"
The European Medicines Agency is preparing for the implementation of the electronic submission of information on medicines.
This is the first deliverable of the new pharmacovigilance legislation...."
and goes on :
"
Phases of implementation
The Agency is applying a phased approach to support the pharmaceutical industry with the implementation of the electronic submission.
Phase one: Notification of the electronic submission format
The Agency published the format for the notification of the electronic submission of medicinal product information in July 2011, which lists all of the data elements required, including the description of the characteristics of the substances contained in medicinal products. The Agency updated this information in September 2011 to include the XML Schema Definition (XSD) for the individual data elements.
The Agency has published a list of controlled vocabularies, which companies should use to fill in fields of the extended EudraVigilance product report messages (XEVPRMs). This list is updated periodically. The XSD schema files and naming conventions for substances are also available.
All documents related to the electronic submission process are available under documents for electronic submission of information on medicines..."
The documents (in English only) have been published on Sept 1st.
Here is the article in full :
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000496.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac05803bf141&jsenabled=true
Have a nice day
Catherine ▲ Collapse
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Thanks Catherine, will go read it right away.
Have a great day!
Anne
| | | | Bruno Depascale 
Italy
Local time: 06:30
Member (2009)
English to Italian
+ ...
| XML Schema Definition (XSD) | Sep 5, 2011 |
Hi everybody,
for what I have understood, there will be specific softwares developed in-house of from third-party vendors that will be used to enter the pharmaceutical data AND their translations.
"Marketing-authorisation holders can now submit information electronically using tools developed in-house by pharmaceutical companies or software vendors".
How can translators be prepared to tackle this issue?
Sincerely,
Bruno
| | | | | Vérifier les capacités des CAT/ Check the CATs abilities | Sep 5, 2011 |
Bruno Depascale wrote:
Hi everybody,
for what I have understood, there will be specific softwares developed in-house of from third-party vendors that will be used to enter the pharmaceutical data AND their translations.
"Marketing-authorisation holders can now submit information electronically using tools developed in-house by pharmaceutical companies or software vendors".
How can translators be prepared to tackle this issue?
Sincerely,
Bruno
Bonjour Bruno,
Je viens de poser clairement la question de l'utilisation possible (ou non) de Wordfast dans ce contexte sur la liste WF française. J'attends la réponse. (voir ci-dessous)
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I just asked the WF French discussion list about the usability (or not) of WF in those circumstances. I'm waiting for answers. (See below).
I'd like to know what CAT(s) is/are the most appropriate to fulfill this new requirements. What's your opinion about this ?
Here's a copy of my message to the WF-FR list :
"Bonjour,
L'EMA (agence européenne des médicaments) a publié le 1er septembre une nouvelle réglementation concernant le traitement des dossiers de demande d'autorisation de mise sur le marché et autres affaires réglementaires.
A partir du 1er janvier 2012, tout document devra être au format XML.
Je voudrais avoir l'assurance que WF pourra me permettre de répondre à ces nouvelles exigences.
Et quel WF ? WFC, WFPro, WFA ?
Sinon, quel logiciel recommanderiez-vous ? Il faut que ça fonctionne *à coup sûr et sans bavure*.
Merci d'avance.
(Pour les traducteurs médicaux non encore informés, voir sur le site de l'EMA :
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000496.jsp&murl=menus/regulations/regulations.jsp&mid=WC0b01ac05803bf141&jsenabled=true )
Bonne journée de rentrée à tous.
Catherine
Catherine GUILLIAUMET - France
Medical Translations
Clinical Medicine and Pharmacology - EN, ES, PT > FR
CGTRADMED
Moderator of the Medical_Translation mailing-list for Professionals
Other sites :http://fr.linkedin.com/in/cgtradmed
http://wwww.viadeo.com/fr/profile/catherine.guilliaumet
Twitter: @Cgtradmed"
[Edited at 2011-09-05 11:16 GMT]
[Edited at 2011-09-05 11:17 GMT]
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Bruno Depascale
Italy
Local time: 06:30
Member (2009)
English to Italian
+ ...
| that would be so good | Sep 5, 2011 |
Catherine GUILLIAUMET wrote:
Bonjour Bruno,
Je viens de poser clairement la question de l'utilisation possible (ou non) de Wordfast dans ce contexte sur la liste WF française. J'attends la réponse. (voir ci-dessous)
---
I just asked the WF French discussion list about the usability (or not) of WF in those circumstances. I'm waiting for answers. (See below).
I'd like to know what CAT(s) is/are the most appropriate to fulfill this new requirements. What's your opinion about this ?
[Edited at 2011-09-05 11:16 GMT]
[Edited at 2011-09-05 11:17 GMT]
Dear Catherine,
in my personal opinion, and according to what I have read so far on the issue, it is very unlikely that translators will be able to work directly on that format.
I think it will be more likely that translators will work directly on in-house softwares developed for the pharmaceutical industry.
But I really hope I am wrong!
Sincerely,
Bruno
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