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Novotel Berlin-Mitte , Berlin, Germany
May 7 2012 9:30AM - May 8 2012 12:00PM
The World Health Organisation (WHO) defines the term Signal as “reported information on a possible causal relationship between an adverse event and drug, the relationship being unknown or incompletely documented previously”. Adverse Drug Reactions (ADRs) may be identified as Signals for clinical and / or quantitative reasons. This course will cover the fundamentals of classical and statistical signal detection and data mining in Pharmacovigilance.
Learning Objectives: At the conclusion of this course, participants should be able to: - Explain and apply the basic concepts and principles of signal detection in Pharmacovigilance
- Explain the role and differences of classical and statistical signal detection in the ongoing safety surveillance of medicinal products
- Outline how to apply signal detection within their function based on the possibilities and limitations of methodology and data
- Employ data mining techniques to analyse large volumes of adverse event report data
- Discuss key messages from the European Medicines Agency Guideline on the uses of statistical signal detection methods in the Eudravigilance Data Analysis System
Event Code: 12555
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Organized by:
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DIA Europe |
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Invited Speakers:
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Jan Petracek, MD,MSc CEO, Director of Pharmacovigilance Services European Pharminvent Services, s.r.o., Czech Republic
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Deadline for Abstracts:
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Call contact
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Registration:
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Contact Information: DIA Europe KUECHENGASSE 16, POSTFACH
4002 BASEL
SWITZERLAND
TEL.: +41 61 225 51 51 FAX: +41 61 225 51 52
E-MAIL: DIAEUROPE@DIAEUROPE.ORG
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E-mail:
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diaeurope@diaeurope.org
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