Translating Pharmaceutical documents and regulations.

Luke Mersh wrote:

@Elif,
Just looking at EMA, mind boggling....
So many regulations, I do not know where to start.

I don't know what even to look for.
regards

Elif Baykara wrote:




@Eileen is right to some extent.

I was not thinking of "really learning all the regulations".

When you translate medical files or regulatory files, there are some rules you have to follow. These may be related to the file style (fonts etc.) and content. Style is something you do not need to think of as long as you do not modify the source file. It is the job of the regulatory affairs department.

When it comes to the content, of course, you don't need to learn the "regulations" regulations unless you have a personal interest

You need to know about CTD and the corresponding titles, section names etc. in your target language. Even though you are able to translate a phrase, there are already approved and required phrases in place (e.g. patient information leaflets). You have to know these details. One example:

"patient information leaflet" when literally translated into turkish is "hasta bilgilendirme broşürü".
But, the correct term adopted by MoH is "kullanma talimatı" (which is the literal translation of "instructions for use").

The link below may provide a starting point:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000134.jsp

Christine Andersen wrote:

I follow Emma Goldsmith chiefly for her advice on Trados Studio, but the medical translation sections are excellent too - and she works with Spanish.

http://signsandsymptomsoftranslation.com/

Try that for sound, readable and very relevant advice.