Title:
Training course on Introduction to Signal Detection and Data Mining in Pharmacovigilance in Europe
Date(s) And Time(s):
Apr 26 2010 8:30AM - Apr 26 2010 4:30PM
Location:
Marriott Rive Gauche
17 , Boulevard Saint Jacques
75014 Paris
France
Overview:
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;
- Asses contemporary methods of quantitative signal detection;
- Identify how to interpret signals;
- Learn about principles in following up on signals;
- Discuss key messages from the EMEA Guideline on the uses of statistical signal detection methods in the Eudravigilance Data Analysis System
Target Audience:
Professionals who work in:
- Pharmacovigilance (including QPPV)
- Clinical Development
- Risk Management
- Pharmacoepidemiology
- Information Technology
- Regulatory Affairs
- Quality and Compliance
- Legal
CANCELLATION POLICY
Cancellations must be made in writing and be received at the DIA Europe office five working days prior to the course start date.
Cancellations are subject to an administrative fee:
Full Meeting Cancellation:
Industry (Member/Non-member) = € 200.00
Government/Academia/Non-profit (Member/Non-member) = € 100.00
Registrants who do not cancel five working days prior to the course start date and do not attend, will be responsible for the full registration fee. DIA Europe reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA Europe is not responsible for airfare, hotel or other costs incurred by registrants. Registrants are responsible for cancelling their own hotel and travel reservations.
Transfer Policy
You may transfer your registration to a colleague prior to the start of the event but membership is not transferable. Substitute registrants will be responsible for the non-member fee, if applicable. Please notify the DIA Europe office of any such substitutions as soon as possible.
Event Code:
10550
Contact Information:
DIA Europe
ELISABETHENANLAGE 25, POSTFACH
4002 BASEL
SWITZERLAND
TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: DIAEUROPE@DIAEUROPE.ORG
|