Back

Login or Register
to download FREE PDF book

Existing user LOGIN
OR
New user REGISTRATION

Register Fill in details Download

Register Fill in details Download

Your download has started.

If the download didn't start automatically, then please click here.

Thank you for the interest in
Practical Aspects of Signal Detection in Pharmacovigilance: Report of CIOMS Working Group VIII

We welcome your feedback on this publication.

Explore more publications

PUBLICATIONS

Practical Aspects of Signal Detection in Pharmacovigilance: Report of CIOMS Working Group VIII

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 pharmacovigil Read more...
  • In Stock
  • isbn: 9290360828
  • Year of publication: 2010
  • Number of pages: 143
  • SKU: 107

Hardcopy paperback at reduced price to increase access. Postage will be added.

1 00 CHF

Amount:


"Practical Aspects of Signal Detection in Pharmacovigilance: Report of CIOMS Working Group VIII" reviews

There are no reviews yet.

×

Please leave your review for Practical Aspects of Signal Detection in Pharmacovigilance: Report of CIOMS Working Group VIII

Be the first to review “Practical Aspects of Signal Detection in Pharmacovigilance: Report of CIOMS Working Group VIII”

Your email address will not be published.

The maximum upload file size: 300 MB. You can upload: image. Links to YouTube, Facebook, Twitter and other services inserted in the comment text will be automatically embedded. Drop file here

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.

CORRIGENDUM

In 2010, CIOMS Working Group VIII published “Practical Aspects of Signal Detection in Pharmacovigilance”. This guideline was well received and has been widely distributed around the world.
CIOMS has now received a note from a careful reader: Dr Parthibaraja Aswathaman, Senior Drug Safety Physician, Medical and Safety Services, Clinical Research Service, Dublin, Ireland, part of a team involved in single case processing and signal detection activities. We therefore issue the following corrigendum:
Currently on page 54, the formula for Information component (IC) is given as
Log2 A(A+B+C+D)/(A+C)(A+D)
The correct formula should be:
Log2 A(A+B+C+D)/(A+C)(A+B)