safety summay

German translation: Zusammenfassender Bericht zur Sicherheit (von Arzneimitteln)

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:safety summary
German translation:Zusammenfassender Bericht zur Sicherheit (von Arzneimitteln)
Entered by: Lucius Passani, Ph.D.

22:01 Apr 13, 2005
English to German translations [PRO]
Medical - Medical (general)
English term or phrase: safety summay
NEW DRUG SAFETY SUMMARY: 1999. Before drugs are approved by the FDA for marketing in the United States they undergo testing in a few thousand
Lucius Passani, Ph.D.
Zusammenfassender Bericht zur Sicherheit (von Arzneimitteln)
Explanation:
This is the URL related to the text given by Lucius:
http://www2.kumc.edu/druginfo/drugsafety/drgsafe99.html

The first paragraphs are only an introduction on what are the tasks / procedures for the goal of drug safety, etc.

Below you find selected FDA documents on special drugs safety issues. These "Summaries" are - if you consider the German BfArM - summarizing reports on a more or less regular basis on drug safety.

"Die Überprüfung eines Arzneimittels auf Qualität, Sicherheit und Wirksamkeit ist jedoch eine permanente Aufgabe, die nicht mit der ersten Zulassung endet. Treten danach weitere Erkenntnisse auf, die eine Anpassung erforderlich machen, müssen auch diese an die jeweilige(n) Behörde(n) weitergegeben werden. Zulassungen müssen ferner in den Ländern der europäischen Gemeinschaft alle 5 Jahre erneuert werden; in dieser Zeit sind je nach Arzneimittel ein bis mehrere ***die neueren Erkenntnisse zusammenfassende Berichte*** erforderlich. ..."
http://www.megra.org/html/affairs.htm

Therefore my suggestion:
[Zusammenfassener] Bericht über die Sicherheit neuer / neu zugelassener Arzneimittel

--------------------------------------------------
Note added at 10 hrs 58 mins (2005-04-14 08:59:53 GMT)
--------------------------------------------------

I made one mistake: The \"New\" is not related to drug, but is the announcement of the - at that time! - new list of documents in 1999!

So I change my suggestion:
\"Aktuell: Berichte zur Arzneimittelsicherheit 1999\"

--------------------------------------------------
Note added at 11 hrs 6 mins (2005-04-14 09:08:23 GMT)
--------------------------------------------------

This again is an excellent example for the often misleading choice of text parts given - and for the need to have rather long!!! text paragraphs in order to make the correct conclusions.

This is not meant as a specific criticism toward the asker Lucius :-)), but in general, toward all askers who pick only some words and think this is enough to help them.
Selected response from:

MMUlr
Germany
Local time: 02:56
Grading comment
Thank you.
Lucius
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1NEUE SICHERHEITSMASSNAHMEN BEI MEDIKAMENTEN:
Dr.G.MD (X)
4(Neue) Arzneimittelvorschriften(: 1999)
Sandy A Pirie
3Zusammenfassender Bericht zur Sicherheit (von Arzneimitteln)
MMUlr
3Zusammenfassung der neuen Anforderungen an die Arzneimittelsicherheit
Steffen Walter


  

Answers


3 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
NEUE SICHERHEITSMASSNAHMEN BEI MEDIKAMENTEN:


Explanation:
Vor ihrer Zulassung durch die FDA....

Dr.G.MD (X)
Local time: 02:56
Specializes in field
Native speaker of: Native in GermanGerman
PRO pts in category: 126

Peer comments on this answer (and responses from the answerer)
agree  Hans G. Liepert
50 mins
  -> Thank you, Hans

neutral  Steffen Walter: würde ich etwas anders formulieren - s.u.
10 hrs

neutral  MMUlr: auch: s. unten
10 hrs
Login to enter a peer comment (or grade)

24 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
(Neue) Arzneimittelvorschriften(: 1999)


Explanation:
Since the safety of drugs is part of the testing procedures, not necessarily mentioning 'Sicherheit' in the translation would seem permissible.

Generische Medikamente
... Die Reform der EU-Arzneimittelvorschriften zielt daher unter anderem darauf ab, die europäischen Generika-Hersteller zu stärken. ...
www.euractiv.com/Article?_lang=DE& acmuri=tcm:31-103658-16&type=LinksDossier


Andererseits ware so etwas auch denkbar:

Zulassungsbedingungen für Medikamente
In Deutschland befinden sich zur Zeit rund 40 000 Arzneimittel auf dem Markt. Jedoch nur etwa 23 000 davon mussten bis jetzt ihre Wirksamkeit, ...
www.netdoktor.de/topic/phyto/pharmatext_marion.htm

Sandy A Pirie
Local time: 01:56
Native speaker of: Native in EnglishEnglish
PRO pts in category: 12
Login to enter a peer comment (or grade)

10 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
Zusammenfassung der neuen Anforderungen an die Arzneimittelsicherheit


Explanation:
IMO this comes closer to what is really meant here (as stated in the sentence following the headline).

Steffen Walter
Germany
Local time: 02:56
Specializes in field
Native speaker of: Native in GermanGerman
PRO pts in category: 268
Login to enter a peer comment (or grade)

10 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
Zusammenfassender Bericht zur Sicherheit (von Arzneimitteln)


Explanation:
This is the URL related to the text given by Lucius:
http://www2.kumc.edu/druginfo/drugsafety/drgsafe99.html

The first paragraphs are only an introduction on what are the tasks / procedures for the goal of drug safety, etc.

Below you find selected FDA documents on special drugs safety issues. These "Summaries" are - if you consider the German BfArM - summarizing reports on a more or less regular basis on drug safety.

"Die Überprüfung eines Arzneimittels auf Qualität, Sicherheit und Wirksamkeit ist jedoch eine permanente Aufgabe, die nicht mit der ersten Zulassung endet. Treten danach weitere Erkenntnisse auf, die eine Anpassung erforderlich machen, müssen auch diese an die jeweilige(n) Behörde(n) weitergegeben werden. Zulassungen müssen ferner in den Ländern der europäischen Gemeinschaft alle 5 Jahre erneuert werden; in dieser Zeit sind je nach Arzneimittel ein bis mehrere ***die neueren Erkenntnisse zusammenfassende Berichte*** erforderlich. ..."
http://www.megra.org/html/affairs.htm

Therefore my suggestion:
[Zusammenfassener] Bericht über die Sicherheit neuer / neu zugelassener Arzneimittel

--------------------------------------------------
Note added at 10 hrs 58 mins (2005-04-14 08:59:53 GMT)
--------------------------------------------------

I made one mistake: The \"New\" is not related to drug, but is the announcement of the - at that time! - new list of documents in 1999!

So I change my suggestion:
\"Aktuell: Berichte zur Arzneimittelsicherheit 1999\"

--------------------------------------------------
Note added at 11 hrs 6 mins (2005-04-14 09:08:23 GMT)
--------------------------------------------------

This again is an excellent example for the often misleading choice of text parts given - and for the need to have rather long!!! text paragraphs in order to make the correct conclusions.

This is not meant as a specific criticism toward the asker Lucius :-)), but in general, toward all askers who pick only some words and think this is enough to help them.

MMUlr
Germany
Local time: 02:56
Specializes in field
Native speaker of: German
PRO pts in category: 355
Grading comment
Thank you.
Lucius
Login to enter a peer comment (or grade)



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