‘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 to the Competent Authority (CA) of the Member State.
ICSRs for all adverse reactions (serious and non-serious) experienced with the EU are required to be submitted to EudraVigilance only following its upgrade by EMA which become effective from 22 November 2017.
ICSR format is precise and exacting and includes:
References for administration and identification purposes, including where the report came from and who received it
All information from primary sources
Characteristics of the patient concerned
Description of the relevant events
Results of clinical tests and procedures
Characteristics of the medicinal product in question
Narrative style summary of the case
Any further relevant supporting information
It is expected that each ICSR should be:
Validated before reporting
Submitted within extremely strict and rapid timescales – starting from the time when minimal information is brought to your attention as the Marketing Authorisation Holder – and this includes your Sales representatives and any contractors
Rapidly re-submitted as new or updated information becomes available which has an impact on the original submission
You also need to be sure that detailed Safety Data Exchange Agreements (SDEAs) exist regarding relevant information exchanges (including information from periodic Literature Searching) with any of your contractors. SDEAs must be formulated to ensure compliance with the interim and final arrangements.
Why Choose PrimeVigilance for your ICSR COMPLIANCE?
Advice from our drug safety services consultants ensures:
You and your staff stay abreast of all the changes
Your submissions remain seamlessly compliant throughout the transition from interim to final arrangements
You avoid onerous and costly penalties accrued through non-compliance
PrimeVigilance uses ArisGlobal LifeSphere Safety MultiVigilance™ and Argus Oracle Health Sciences leading safety databases. With over 10 years dedicated to providing pharmacovigilance services, our employees have been processing Individual Case Safety Reports (ICSR) and drug safety data for many years. Our system server is secure, with appropriate back-up and disaster recovery programmes in place.
We offer a cost-effective solution for managing your legacy safety data as well as taking care of your company’s future needs for processing ICSRs. Our experienced pharmacovigilance physicians are involved in reviewing MedDRA coding and in themedical assessment of all cases. We carry out full quality control on each report.
We have a specialised submissions team who are qualified users of EudraVigilance for electronic reporting. Case disposition is tracked and contributes to metrics for regulatory and quality compliance monitoring. Regulatory intelligence is key part of this team’s role to ensure we keep abreast of any changes in the regulations and update our core regulatory reporting requirements table accordingly.
We understand the need for keeping to time, for making the right decisions about expedited reporting and for keeping the appropriate people in your company informed If necessary we can tailor our established standard practices to your specific requirements. The whole system is subject to internal audit and is also open to your scrutiny.
However, entering data into a safety database is only a small part of the requirements for pharmacovigilance. Regular management reports, routine signal detection, database searches for signal evaluation, periodic safety update reports or responses to regulatory authority enquiries all attract the same attention to quality and application of medical expertise. At PrimeVigilance, if it needs a medic we use a medic, but it need not cost you the earth.
Reference 1. European Commission. Vol 9a of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use.
PLEASE NOTE: EU drug safety laws are complex here and changing – this document is provided for education purposes and cannot be interpreted as any statement of meaningful professional advice.