German to English translations [PRO]
Science - Medical: Pharmaceuticals / Pharmacovigilance | | German term or phrase: Anzeigeverpflichtungen | from an SOP re processing complaints:
Pharmacovigilance Manager ist verantwortlich für: Initialbewertung aller Reklamationen, Risikoabschätzung und Einhaltung möglicher gesetzlicher Anzeigeverpflichtungen.
I think the „Anzeigeverpflichtungen“ arise under the AMG – I’ve seen this transalted as "reporting duties“ but is there a more common term for this? |
| KenOldfieldKudoZ activityQuestions: 761 ( 3 open) ( 51 without valid answers) ( 19 closed without grading) Answers: 0
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| | (regulatory) reporting obligations | Explanation:
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Note added at 14 Min. (2009-10-28 16:42:17 GMT)
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Uponstudy closure, the investigator will be required to certify that the study wasconducted and the Pfizer grant funds and/or drug were used solely toconduct or report the study and that all safety reporting obligations weremet.
http://209.85.129.132/search?q=cache:MWGF3psX4WsJ:media.pfiz...
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Note added at 17 Min. (2009-10-28 16:44:53 GMT)
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Additional Reporting Obligations for Investigators-Sponsors
When an Investigator files an IND, the Investigator is considered the Sponsor and as such carries all of the FDA regulatory responsibilities and reporting obligations of both the Investigator and Sponsor as outlined below described in the FDA regulations 21 CFR 312 (drugs) and 21 CFR 601 (biologics). Please refer to the regulations for complete information.
• FDA reporting obligations of investigators under an IND include:
• Drug disposition
• Case histories
• Progress reports
• Safety reports
• Final report
• Financial disclosure report
•
Specific record keeping and record retention
• FDA reporting obligations of sponsors under an IND include:
• Protocol amendments
• Information amendments
• IND Safety Reports
• Annual Reports
• Withdrawal of an IND
•
Specific record keeping and retention
http://www.research.ucsf.edu/chr/guide/chrIND.asp#10 |
| Selected response from:
 Susanne Schiewe (medical & IT translations)
Germany
Local time: 14:31
| Grading comment Many thanks
3 KudoZ points were awarded for this answer |
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| Discussion entries: 0 |
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Automatic update in 00:
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13 mins confidence:   peer agreement (net): +2 | (regulatory) reporting obligations
Explanation:
.
--------------------------------------------------
Note added at 14 Min. (2009-10-28 16:42:17 GMT)
--------------------------------------------------
Uponstudy closure, the investigator will be required to certify that the study wasconducted and the Pfizer grant funds and/or drug were used solely toconduct or report the study and that all safety reporting obligations weremet.
http://209.85.129.132/search?q=cache:MWGF3psX4WsJ:media.pfiz...
--------------------------------------------------
Note added at 17 Min. (2009-10-28 16:44:53 GMT)
--------------------------------------------------
Additional Reporting Obligations for Investigators-Sponsors
When an Investigator files an IND, the Investigator is considered the Sponsor and as such carries all of the FDA regulatory responsibilities and reporting obligations of both the Investigator and Sponsor as outlined below described in the FDA regulations 21 CFR 312 (drugs) and 21 CFR 601 (biologics). Please refer to the regulations for complete information.
• FDA reporting obligations of investigators under an IND include:
• Drug disposition
• Case histories
• Progress reports
• Safety reports
• Final report
• Financial disclosure report
•
Specific record keeping and record retention
• FDA reporting obligations of sponsors under an IND include:
• Protocol amendments
• Information amendments
• IND Safety Reports
• Annual Reports
• Withdrawal of an IND
•
Specific record keeping and retention
http://www.research.ucsf.edu/chr/guide/chrIND.asp#10
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