ADR Reporting, MedicationADR Reporting, MedicationError Reporting SystemError Reporting System(MERS) & Cold Chain(MERS) & Cold ChainManagementManagement
Updates from ‘Bengkel Laporan KesanUpdates from ‘Bengkel Laporan Kesan Advers Ubat-Ubatan dan Vaksin’ Advers Ubat-Ubatan dan Vaksin’ 18-20 March 200918-20 March 2009Organized By: Bahagian PerkhidmatanOrganized By: Bahagian PerkhidmatanFarmasi, KKM Farmasi, KKM
Pharmacovigilance:Pharmacovigilance:Ensuring the Safe use of Ensuring the Safe use of Medicine and Role of Medicine and Role of PharmacistsPharmacists
Registration CriteriaRegistration Criteria
EfficacyEfficacy
–
Evaluated from data obtained from clinical trialsEvaluated from data obtained from clinical trials
QualityQuality
–
Compliance to established standards,Compliance to established standards,manufacture by GMP licensed premisemanufacture by GMP licensed premise
Safety**Safety**
–
Toxicology, clinical trialsToxicology, clinical trials
** (Very limited information)** (Very limited information)
(Further established through post registration studies)(Further established through post registration studies)(Discovering new dangers of drugs after marketing is common)(Discovering new dangers of drugs after marketing is common)
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ADR Reporting, Medication Error Reporting System
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