Analysis of similar events (AOSE) The sponsor must identify in each IND safety report, all IND safety reports previously submitted to Food […]
Blog Archive
0
Summary of key health product safety information from Health Canada InfoWatch newsletter
Summary of key health product safety information from Health Canada InfoWatch newsletter This is a monthly publication and is intended primarily for […]
0
EMA releases guidance on the use of Regdanvimab for treating COVID-19
EMA releases guidance on the use of Regdanvimab for treating COVID-19 On 26 Mar 2021, EMA’s human medicines committee (CHMP) has completed […]
1
Risk of thrombocytopenia and coagulation disorders with the use of COVID-19 Vaccine AstraZeneca
Risk of thrombocytopenia and coagulation disorders with the use of COVID-19 Vaccine AstraZeneca European Medicines Agency (EMA) has published Direct healthcare professional […]
1
Important Medical Event (IME) list
Important Medical Event (IME) list In the Pharmacovigilance process, to facilitate the seriousness assessment of a reported event, the safety team should […]
0
Risk of Severe Cutaneous Adverse Reactions (SCARs) with atezolizumab
Risk of Severe Cutaneous Adverse Reactions (SCARs) with atezolizumab 25 MArch 2021: European Medicines Agency (EMA) has published Direct healthcare professional communication […]
6
Pharmacovigilance interview questions for freshers 2021
Pharmacovigilance interview questions for freshers 2021 What is Pharmacovigilance? Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from […]
0
Safety concerns of COVID-19 Vaccines
Safety concerns of COVID-19 Vaccines Here we are listed out COVID-19 Vaccine’s safety concern. BioNTech, Dated: 20 December 2020 The safety concerns […]
