Question

What are the major benefits of being able to share information in individual case safety reports (ICSRs) and view reports submitted in other countries?

Answer 1

ANSWER

Individual Case Safety Report (ICSR) captures information needed to support reporting of adverse events, product problems and consumer complaints associated with the use of FDA regulated products.

All adverse events of the medicines and products occurring in a post-marketing situation and qualifying for your national ICSR database should be shared with the other members of the WHO Programme, both serious and non-serious cases.

VigiBase is mainly a database for spontaneous ICSRs on registered medicinal products. However, UMC also accepts cases from clinical trials and literature; the type of report should be specified in the ICSR.

ICSRs on medication errors, counterfeit/substandard medicines and therapeutic failure should also be submitted. ICSRs on ordinary allopathic medicines, traditional medicines (herbals), as well as biological medicines, including vaccines, should be shared.

Medicines in combination with medical devices should also be sent. ICSRs on veterinary medicines, cosmetic/hygiene products or medical devices are not within the scope of the WHO Programme and should not be shared in VigiBase.

• Expertise in ICSR case management including case triage/book-in, case processing, narrative writing, medical review, quality control and submission
• Staff with hands-on experience in handling/managing standard and customized safety databases like Aris G, Oracle Argus, Adverse Event Reporting System (AERS), FDA's AERS (FAERS)
• Experience in conducting mock audits, training on facing inspections, support in preparing Corrective and Preventive Action (CAPA) and remediation activities
• Extensive experience in PV process harmonization and creation of Company Core Data Sheet (CCDS) and Core Safety Information (CSI)
• Experience in tracking safety variations and PV System Master File (PSMF) compliance
• Defined processes of thorough scientific, medical, editorial and quality control review
• Timely delivery with the highest standard of quality
• Expert program and project management support to maintain compliance