What is an ICSR
A report that contains information describing a suspected adverse drug reaction related to the administration of one or more medicinal products to an individual patient is termed as individual case safety report.
Safe use of medicines continues to be a crucial issue globally and is the prime responsibility of stakeholders of the health system. Besides the patient identification data, it should also specify time frames of the adverse reactions, details of medications used, dechallenge and rechallenge details to mention a few. These ICSRs need to be submitted within rigid time frames as specified by the regulatory authorities.
Our robust and erudite team will not only formulate the ICSRs with utmost attention to all nuances but also ensures that they are submitted within the stipulated timeframes. The team has years of experience in the sensitive field of PV and is well versed with the regulatory requirements making them apt for this job.
Fact: EU Pharmacovigilance laws state that all spontaneous reports regarding serious adverse reactions must be expedited within 15 days. In addition, from November 2017 all non-serious adverse reactions, with an origin within the EU, require expediting to EMA within 90 days.
This implies that all reactions need to be fast tracked to meet the timelines. It is interesting to note that failure to be compliant with expedited reporting is one of the common causes for penalty and losses to MAH.
It is inevitable that submission of the report in the exacting format within the short challenging period can be a cause of demurral in services many a time. What is required is a team which believes in flight and fright reaction at the appropriate times and doesn't dawdle in these tricky situations. The team at AWINSA Life Sciences thoroughly knows the intricacies of the regulations and has systems and processes in place to help prioritize their action. They are well equipped to cut the Gordian knot efficiently and will ensure smooth delivery of services at your end.