News

New course: Signal Detection and Management in Pharmacovigilance

Fri 11 Sep 2015 @ 11:05

Zenosis, the leading provider of eLearning for the medicinal products industry, has announced the release of a new course: PV04: Signal Detection and Management in Pharmacovigilance. The release is the first in a programme of expansion of the Zenosis product range in the area of drug safety and pharmacovigilance. The new course complements the introductory module PV03 and will be followed soon by PV05 on risk management planning. Other modules are in development. Together with the rapid expansion of the company's range of courses on Good Manufacturing Practice, and established modules on clinical research and regulatory submissions, Zenosis is on track to offer the world's most extensive library of eLearning for the pharmaceutical and biotechnology industries.

The fundamental aim of drug safety assessment is to establish what adverse reactions may be caused by a medicinal product. Factors such as seriousness, severity, and frequency of reactions are then taken into account, along with the medical benefit of the drug, in establishing the benefit/risk profile of the product.

Product licence holders and regulatory authorities monitor the safety of licensed drugs to detect adverse reactions that are unexpected qualitatively or quantitatively and that alter benefit/risk balance, and they take risk minimisation action as necessary. Such pharmacovigilance principally involves the identification and evaluation of safety signals in information obtained from a wide range of data sources.

The methods used range from traditional medical assessment of individual spontaneous reports of adverse events, through ‘data mining’ of large databases, observational studies of ‘real world’ prescription and use, to interventional clinical trials.

The new course provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four stages: signal detection, signal validation, signal analysis and prioritisation, and risk assessment and minimisation.

All staff working in medical, drug safety, or pharmacovigilance departments of pharmaceutical or biotechnology companies or contract research organisations should have access to this module. It will also be of value to healthcare professionals and regulatory authority personnel.

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