Re: DE > EN Stufenplanbeauftragter, Informationsbeauftragter

[Guest guest]

Hi Ken,

According to

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=7\

640512 & dopt=Abstract,

a Stufenplanbeauftragter is a qualified person who is responsible for

the fulfillment of obligatory reporting

Informationsbeauftragter is Person legally responsible for

information

(http://www.google.com/search?q=Informationsbeauftragter+responsible & btnG=Search\

& hl=en & lr= & c2coff=1 & rls=GGGL%2CGGGL%3A2006-23%2CGGGL%3Aen)

According to the same Google search, a Sachkundige Person is simply a

qualified person and may even be a synonym for Informationsbeauftragter.

Mind you, I don't normally translate this sort of thing so you might

want to confirm it.

Jill

>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

>(Stufenplanbeauftragter, Informationsbeauftragter, Sachkundige Person) "

>

>What are Stufenplanbeauftragter and Informationsbeauftragter? Is the first

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

>Informationsbeauftragter? Is this a spokesperson?

>

>Any help appreciated.

>

>All the best,

>

>Ken

>

>

> Kronenberg

>German translator / writer / editor

>

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[Guest guest]

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

>

> 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