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INDIVIDUAL CASE SAFETY REPORTS:
SOLICITED REPORTS
SPONTANEOUS REPORTS
ICSR
PSP (Patient support programme)
MRP(Market Research Programme)
Regulatory authority sources
NOT TO REPORT
clinical trial registries
contractual agreements
WHAT TO REPORT
internationally standardized procedure in order to
improve the quality of safety information and to harmonise the way of gathering and reporting information.
ICH E2A: guideline on pre-approval safety data management.
ICH E2D: Guideline for post approval safety data management.
-SERIOUS UNEXPECTED ADR
-IMPORTANT SAFETY FINDINGS (Teratogenicity, Mutagenicity, Carcinogenicity, increased mortality)
-OTHER OBSERVATIONS: Lack of efficacy, overdose, misuse, abuse, medication error, medication error.
-USE IN PREGNANCY/LACTATION.
-OFF LABLE USE
-SERIOUS EXPECTED
-NON SERIOUS UNEXPECTED
- NON SERIOUS EXPECTED.
-OTHER OBSERVATIONS- No serious AE/ADR
ADVERSE EVENT (AE)
ADVERSE DRU REACTION (ADR)
SERIOUS AE/ADR
UNEXPECTED SERIOUS ADR/AE
EXPECTED/ UNEXPECTED AE/ADR
SERIOUS UNEXPECTED- 15 DAYS
MINIMUM CRITERIA:
1. IDENTIFIABLE PATIENT
2. IDENTIFIABLE REPORTING SOURCE.
3. SUSPECTED MEDICINAL PRODUCT.
4. EVENT OR OUTCOME- SERIOUS UNEXPECTED
EXPEDITED REPORTING
LIFE THREATENING- 7 DAYS+ ADDITIONAL 8 DAYS FOR REPORTING
NON SERIOUS AE- IN PSUR
(avoid case duplication, ensure authenticity, and facilitate follow-up of appropriate cases).