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Re: AW: Re: DE > EN Stufenplanbeauftragter, Informationsbeauftragter

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What Astrid points out underscores why I almost always turn down business

and finance and other translations that are likely to be heavy with

official corporatese. I have no experience with that world either in

English or in German and it simply feels alien. Even when I read this

material, it is often difficult for me to create a mental picture of what

it actually is. Particularly when I'm pressed for time. Perhaps I'm not the

only one with this limitation.

But Astrid is certainly right that a footnote would be appropriate --

particularly now that I (we) have the English version of the AMG.

All the best,

Ken

At 02:55 PM 2006-11-17, you wrote:

>I need to get on with my own work, but I would still like to offer the

>following comments:

>

>Probably, I should have taken the time to write a longer reply yesterday,

>mentioning some of the facts below.

>

>

>

>I couldn't agree more with the statement that " scientific fact checker " is

>inappropriate. I had provided the reference to the AMG, which clearly

>describes the many functions of such person (as defined in the AMG - this is

>important to note!).

>

>Concerning the term " safety and Information officer " . well, this is better

>than the above, but am not so sure this actually matches the functions

>described in the AMG, because the " Informationsbeauftragte " is not concerned

>with the monitoring of adverse events at whatever stage (prior to or after

>marketing approval).

>

>

>

>In this context it is important to be aware of false friends, since titles,

>degrees etc. may have another meaning in a different companry and a

>different system. Simply providing a term, which sounds good and close

>enough, does not do the trick in my opinion. It is the translator's

>responsibility to point out the specific meaning, if necessary, in a

>footnote or otherwise.

>

>Attention also needs to be paid to the audience. I am assuming that Ken is

>translating for a US-audience, but that also may be incorrect.

>

>

>

>My two cents.

>

>Astrid

>

>

>

>

>

> _____

>

>Von: medical_translation

>[mailto:medical_translation ] Im Auftrag von T. Creutz

>Gesendet: Friday, November 17, 2006 4:58 PM

>An: medical_translation

>Betreff: Re: DE > EN Stufenplanbeauftragter, Informationsbeauftragter

>

>

>

>The title of the person responsible for both " pharmacovigilance "

>(monitoring of adverse drug reactions) and " information " in a

>pharmaceutical company is usually Safety and Information Officer.

>An " Informationsbeauftragter " is an Information Officer, in that and

>a host of other contexts. This person is more than a data verifier

>( " scientific fact checker " ).

>

> Creutz

>Weymouth, MA, USA

>

>

> >

> > Hi Ken,

> >

> >

> >

> > Sorry for the late reply.

> >

> >

> >

> > Regarding the " Informationsbeauftragter " you will find a formal

>definition

> > under: < <http://www.bmj.bund.de/jur.php?amg_1976,74a>

>http://www.bmj.bund.de/jur.php?amg_1976,74a>

> > <http://www.bmj.bund.de/jur.php?amg_1976,74a>

>http://www.bmj.bund.de/jur.php?amg_1976,74a

> >

> > Here, you will also find that the " Stufenplanbeauftragte " and the

> > " Informationsbeautragte " can be one and the same person (as

>suggested by the

> > title " Manager Drug Regulatory Affairs & Pharmacovigilance " ). It

>will depend

> > on the organisational structure and the size of the company whether

>one or

> > more persons perform these functions.

> >

> >

> >

> > In plain words the " Informationsbeauftragte " is a person in a

>pharmaceutical

> > company, who is responsible for providing medical/pharmaceutical

> > information, but also has other functions that would come under

>regulatory

> > affairs.

> >

> >

> >

> > As for pharmacovigilance manager and " Stufenplanbeauftragter " I

>would

> > probably want to call such a person " Manager Drug Safety &

> > Pharmacovigilance " . Although the term pharmacovigilance is

>sometimes used in

> > a broader sense, in a stricter sense it only involves procedures

>after the

> > market approval of drugs [ahem, medicinal products, in order not to

>offend

> > our dear colleague Kinori]. However,

>the " Stufenplanbeauftragte " , is

> > also concerned with drug safety during the clinical development

>phase.

> >

> >

> >

> > Best,

> >

> > Astrid

>

>

>

>

>

>

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