Practical Aspects of Signal Detection in Pharmacovigilance

Ebook

In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations.

These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners.

The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems.

Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.

Download Now Read Online

Practical Aspects Of Signal Detection In Pharmacovigilance


Download Now Read Online

Author by :
Languange Used : en
Release Date : 2010
Publisher by : Cioms

In recent years public expectations for rapid identification and prompt management of emerging drug safety iss

Practical Aspects Of Signal Detection In Pharmacovigilance


Download Now Read Online

Author by :
Languange Used : ja
Release Date : 2011-07
Publisher by :

最近では、新たに発生した医薬品の安全性の問題点を、できる限り早期に特定し

Drug Safety Data How To Analyze Summarize And Interpret To Determine Risk


Download Now Read Online

Author by : Michael J. Klepper
Languange Used : en
Release Date : 2010-10-25
Publisher by : Jones & Bartlett Publishers

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinica

Pharmacovigilance Medical Writing


Download Now Read Online

Author by : Justina Orleans-Lindsay
Languange Used : en
Release Date : 2012-06-22
Publisher by : John Wiley & Sons

Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the

Pharmacovigilance


Download Now Read Online

Author by : Ronald D. Mann
Languange Used : en
Release Date : 2007-02-06
Publisher by : John Wiley & Sons

Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd Edition is th

Mann S Pharmacovigilance


Download Now Read Online

Author by : Elizabeth B. Andrews
Languange Used : en
Release Date : 2014-03-24
Publisher by : John Wiley & Sons

Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference fo

An Introduction To Pharmacovigilance


Download Now Read Online

Author by : Patrick Waller
Languange Used : en
Release Date : 2017-02-14
Publisher by : John Wiley & Sons

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and preve

Leave a Reply