Questions & Answers Blog on recent webinar on ‘Impetus to Literature surveillance in pharmacovigilance on wheels of automation’

April 9, 2015

Questions & Answers Blog on recent webinar on ‘Impetus to Literature surveillance in pharmacovigilance on wheels of automation’These are few of the questions raised by Webinar audience regarding Literature automation module (LAM) of PvNet and their appropriate responses

1) Can we integrate the cases into different safety databases?

Yes, it is possible in LAM to integrate cases (ICSRs) into different safety databases

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Surpass limitations of Literature monitoring in Drug safety with flexible and versatile approach

March 16, 2015

Surpass limitations of Literature monitoring in Drug safety with flexible and versatile approachWith the advent of technology, we are cocksure to upgrade ourselves not only to fear that we would turn obsolete soon but also to accomplish the objective of organizational Good pharmacovigilance practices.

For any drug that sees light of the day, there are case studies that will be published, research and review articles that would be written by the researchers working to discover the yet unknown or to confirm the trial findings on a pivotal scale.

The existence of each of these literature of interest will ultimately be cycled to manage the regulatory reporting and document the literature screening activity, as an essential part of routine pharmacovigilance surveillance.

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Questions & Answers of webinar (Feb 2015) on Signal detection methodology: Current and Novel approaches

March 5, 2015

Questions & Answers of webinar (Feb 2015) on Signal detection methodology: Current and Novel approachesThis Questions & Answers Blog are from Signal Detection Webinar conducted in February 2015.

1) Which level of grouping or selection for AE term is used?
Usually the Lowest level term (LLT) that precisely reflects the reporter’s verbatim should be selected. However, the MedDRA coder should also check the hierarchy of the terms selected (i.e., PT, HLT, HLGT and SOC) as it is also important to select the LLT falling under correct hierarchy which otherwise would lead to erroneous coding.
Also, it is equally important to ensure good coding practices by establishing company procedures and having a quality check so as to ensure correct information as is reported goes in the case. In PvNET, when an LLT term is selected, the system automatically enters the related PT term in the data field.
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Medicinal product ‘inquiry’ centers: An infallible mechanism to combat efficacy, safety, quality and other product challenges

February 24, 2015

Medicinal product ‘inquiry’ centers: An infallible mechanism to combat efficacy, safety, quality and other product challengesIf a Marketing Authorization Holder (MAH) nurtures a molecule and gives it a proper shape in form of a palatable dosage form with various types, i.e., in different strengths and route of administration(s), they also are required to keep a track-record of how the product is behaving in pharmacokinetic, pharmacodynamic and more so, pharmacogenetic pattern, once marketed.

Documenting and routing of all the product related inquiries can aid in analysis of product trend eventually with a span of its time spent in market. Simply adverse event monitoring is not a sufficient measure to comply to this dire need and the issues faced are to be addressed on a wider platform, also termed as Product information/inquiry evaluation and response.

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Things You should know about Pharmacovigilance ‘Signal’!

January 21, 2015

Things You should know about Pharmacovigilance ‘Signal’!Signal detection and validation by Marketing Authorization Holders is an integral pharmacovigilance activity and should be carried out intermittently because ‘Signal’ may pop up out of the blue necessitating appropriate evaluation or justification, as the case may be.

Things You Should know to Manage a ‘Safety Signal’
Does the Safety Signal warrant further investigation or should be refuted ? Who is going to decide and document?

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