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Pooling meaningful data from vast Pharmacovigilance database for Regulatory periodic reports
There exist regional and universal guidelines emphasizing the type and nature of data that needs to be submitted in the Periodic update reports (or so called ‘aggregate reports’). Few of those are listed below: EMA’s Good Pharmacovigilance Practices – Management and reporting of adverse reactions to medicinal products (Rev 1), Periodic safety update report (rev […]
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Surpass limitations of Literature monitoring in Drug safety with flexible and versatile approach
With 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 […]
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Medicinal product ‘inquiry’ centers: An infallible mechanism to combat efficacy, safety, quality and other product challenges
If 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, […]
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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 […]
