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pharmakovigilanz

WHO definition of pharmacovigilance: " … The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem …" (The Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring: The Importance of Pharmacovigilance, 2002)
 
We offer very special services: Trainings...
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Schulung
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On the correct practice with terms: differentiation between "pure" events, AE/SAE and adverse reactions, AR, SAR. What are "unexpected adverse reactions? What are SUSAR?
(see:: "Short Glossary")
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Training in interpretation of the local laws and international Guidelines and Directives (GCP, EMEA, FDA, German AMG etc.)
(see: "Notes for Guidances / Guidelines / Directives" for downloading) download)
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Statistical aspects of the analysis of adverse reactions, signal detection etc.
(see: "Cooperation with other institutions")
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  Practical Help...
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Praktischehilfe
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Consulting in "Expedited Reporting" of serious adverse reactions, SAR (15 days or 7 days reports), especially in "not labelled" reactions - SUSAR - to be reported to authorities and Ethics Committees according to the European Directive 20/2001/EC, FDA and/or local laws, respectively
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punktElectronic Reporting Systems: central reporting of SUSAR to the EMEA; support and consulting in the development / selection / validation of systems
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PhV System Audits
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Support in preparing for PhV inspections by the authorities (EMEA, FDA, BfArM,) according to the respective guidelines and local laws
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SOPs for a PhV System (also for Data Management, Statistics, Computer Systems Validation etc.)
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PhV Planning according to ICH Note for Guidance, Topic E2E, which requires PhV plans for each particular drug:
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Preparation of PhV Plans
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Prospective Risk Management
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43581. Besucher

 
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