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Pharmacovigilance Operations – Postmarketing

Case processing (ICSRs)

What Is An ICSR & How Will They Change? ‘ICSR’ refers to Individual Case Safety Reports which must be compiled for each instance of a suspected or confirmed adverse event and each reception of a report about one. Your company … Continue reading

Expedited reports

Fact: EU pharmacovigilance laws mean that ALL spontaneous reports regarding serious adverse reactions must be expedited within 15 days. In addition, by Q3 2017 all non-serious adverse reactions will also require expediting. Fact: These laws will mean that ALL suspected reactions provoked by a medicinal product must be expedited – regardless of severity … Continue reading

Periodic reporting (PSURs/PBRERs)

Companies are required to prepare detailed periodic safety update reports on all their products that have marketing authorisation in the EU. The PSURs provide an overview of safety and efficacy (GVP Module VII) over a defined interval: they … Continue reading

Literature screening

Why Are Correct Screening Procedures So Important? GVP Module VI makes it clear that regulators expect consistent screening to be an integral part of your day-to-day drug safety operations. For each marketing … Continue reading

Safety signals

Business-Critical Responses – Your Processing of Safety Signals All drugs safety monitoring activities involve the collection and processing of tremendous amounts of drug safety data. When it comes to processing data related to Adverse Reactions, your work must demonstrably meet …