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Regulatory Services in South AfricaPatient safety is of utmost importance and the root of all decisions along the entire drug development pipeline. Systems must be established to ensure that safety related data is collected and managed appropriately to mitigate potential or confirmed risks relating to a pharmaceutical product. ICSR processing and submission are integral components of pharmacovigilance as they provide critical safety data in the form of adverse reactions of serious & non serious nature with cause & effect analysis. The ADRs are received from various sources that include, but are not limited to, Health Care Providers (HCPs), patients, consumers (spontaneous reports), scientific literature, clinical studies, epidemiological studies, and any post-approval clinical/safety studies that have been conducted.
DDReg understands the importance of adhering to global and national ICSR Case Processing requirements. Our ICSR Pharmacovigilance Services comprehensively covers all stages of case reporting, be it case receipt, duplicate check, triage, data entry, quality check, medical review, case publishing and/or final submission. Our highly experienced team processes the ICSRs received from various sources and provides our customers with end-to-end assistance in handling diverse reports.
DDReg’s ICSR Processing & Submission capabilities include:
- Receiving Adverse drug events, Medical Information queries & Product Quality Complaints.
- Triage of initial and follow-up ICSRs, SUSARs,
- Case Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
- Quality Check, Medical reviews
- Submission of cases as per agency timelines
- Maintaining ICSR monitoring & tracking sheets
- Reconciliation process with customers
