EMA/Member States governance structure for pharmacovigilance EU Individual Case Safety Report (ICSR)0F Implementation Guide. ‘ICSR’ refers to Individual Case Safety Reports which must be compiled for each instance of a suspected or Pharmacovigilance Operations – Postmarketing. Description: The HL7 Individual Case Safety Report (ICSR) Pharmacovigilance – Structure and data elements of individual case safety report.

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One of the lcsr important, and challenging, problems in pharmacovigilance is that of the determination of causality. This article possibly contains original research. We carry out full quality control on each report. But anonymous reporting is also important, as whistle blower protection is not granted in all countries. Create clinical and regulatory documents to support all stages of your drug and device development.

These queries are sent to the reporter, and once the reply is received, the data is updated in the case. For the case processor, every case is different, pharacovigilance within the same study. Disclaimer All opinions expressed herewith are those of the authors, and do not reflect the views of their organizations.

The source of AE reports may include: Unsourced material may be challenged and removed. Defining what constitutes hospitalization can be problematic as well. The purpose of medical coding is to convert adverse event information into terminology that can be readily identified and analyzed.

Such intensive schemes, however, tend to be the exception. Guidance for marketing-authorisation holders. You can help improve this article by introducing citations that are more precise. Although somewhat intuitive, there are a set of criteria within pharmacovigilance that are used to distinguish a serious adverse event from a non-serious one.


Guidance is also available on withdrawn products notification and risk-management plans. Data mining pharmacovigilance databases is one approach that has become increasingly popular with the availability of extensive data sources and inexpensive computing resources.

An example of phxrmacovigilance device in the “high risk” category would be cardiac pacemakers. Table of contents Guidance for marketing-authorisation holders Pharmacovigilance practices. This is because the reporter has first-hand information about the patient and is identifiable i.

Finally, “medically significant events” is a category that includes events that may be always serious, or sometimes serious, but will not fulfill any of the other criteria. If the reporter has not provided the causality assessment, the case processor can also assess the case causality.


Author information Copyright and License information Disclaimer. In addition, the standard also strengthens personal data protection in the records of ICSRs collected by pharmaceutical companies and regulatory authorities. The role of a case processor is to monitor and track all serious adverse events, serious and medically significant adverse drug reactions ADRsand other medical-related product information followed by timely processing and reporting of such information in accordance with the company and regulatory reporting timelines.

Adverse event information phsrmacovigilance be generated from various modes, for example, clinical trials, post marketing programs, spontaneous reports, and literature or legal reports.

Once the case has been triaged, the case processor will perform the complete data entry. Optimizing product development to ensure commercial success. Examples range from simple devices such as tongue depressorsmedical thermometersand disposable gloves to advanced devices such as medical robotscardiac pacemakersand neuroprosthetics.


Nevertheless, the determination of risk factors is an important step of confirming or ruling-out a causal relationship between an event and a drug. Case receipt Mailbox management The first thing a case processor will do is to check the email after logging in to the system. There can be challenges while handling all these tasks at a time, hence the associate will have to maintain a balance to overcome them and keep on updating their knowledge on drug safety regulations, which in turn, would help in increasing their learning curve.

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A day in the life of a pharmacovigilance case processor

This article describes the activities a case processor performs every day, during PV data management. Medical Dictionary for Regulatory Activities. Let’s look at each task in which a case processor is involved on a daily basis.

Events such as cancer might always be considered serious, whereas liver disease, depending on its CTCAE Common Terminology Criteria for Adverse Events grade—Grades 1 or 2 are generally considered non-serious and Grades serious—may be pharmacovigilacne non-serious.

An example of a device in the “low risk” category would be contact lenses.

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