Found 14 presentations matching your search
The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. The...
Here is a detailed description of ICH guidelines for PBRER (ICH E2C R2) & Expedited reporting (E...
GVP intro
Introduction to Drug Safety & Pharmacovigilance Process Work Flow for Pharmaceuticals, Bio-Pharm...
Aggregate reporting in pharmacovigilance refers to the process of collecting and analyzing data from...
Japan Regulation Drug Regulatory Affairs
ICH guidelines
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOM...
CIOMS
The New Drugs and Clinical Trials Rules, 2019 (NDCT Rules, 2019) apply to all new drugs, investigati...
El modulo VII de las GVP define como se debe realizar un PSUR, con el fin de actualizar el balance r...
According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already impleme...
A Risk management plan is a document based on safety profile of medicines that collects all pharmaco...
Critical discussion addressing the current benefit/risk balance for the product on the basis of a co...
