AW: DE > EN Stufenplanbeauftragter, Informationsbeauftragter

[Guest guest]

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

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

_____

Von: medical_translation

[mailto:medical_translation ] Im Auftrag von

Kronenberg

Gesendet: Thursday, November 16, 2006 7:17 PM

An: medical_translation

Betreff: Re : DE > EN Stufenplanbeauftragter, Informationsbeauftragter

Dear Charlotte and Karina,

Excellent! As is " pharmacovigilance manager, " given the circumstances.

Since that is the term they use in German, I think I'll go with that.

All the best,

Ken

At 12:02 PM 2006-11-16, you wrote:

>Hi Ken

>

>This is a site which explains the terms you are looking for. I hope it

>will help.

> <http://www.medscape.com/medline/abstract/7640512?prt=true>

http://www.medscape.com/medline/abstract/7640512?prt=true

>Sicnerely,

>

>KARINA PETERSON

>

>

>

>----- Message d'origine ----

>De : Kronenberg < <mailto:kfkronenberg%40earthlink.net>

kfkronenberg@...>

>À : <mailto:medical_translation%40yahoogroups.com>

medical_translation

>Envoyé le : Jeudi, 16 Novembre 2006, 11h09mn 27s

>Objet : DE > EN Stufenplanbeauftragter, Informationsbeauftragter

>

>Hi all,

>

>In a list of permanent members of a Committee for Medicinal Product Safety

>(in the original German text):

>

> " Manager Drug Regulatory Affairs & Pharmacovigilance

>(Stufenplanbeauftra gter, Informationsbeauftr agter, Sachkundige Person) "

>

>What are Stufenplanbeauftrag ter and Informationsbeauftr agter? Is the

first

>one a person authorized to carry out the phase plan? And what about

>Informationsbeauftr agter? Is this a spokesperson?

>

>Any help appreciated.

>

>All the best,

>

>Ken

>

> Kronenberg

>German translator / writer / editor

>

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