Analysis of similar events (AOSE) The sponsor must identify in each IND safety report, all IND safety reports previously submitted to Food […]
Blog Archive
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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 […]
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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 […]
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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 […]
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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 […]
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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 […]
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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 […]
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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 […]
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Risk of serious liver failure with Ulipristal
Risk of serious liver failure with Ulipristal On 18 February 2021, MHRA issued drug safety update on Ulipristal acetate 5mg (Esmya). Esmya […]
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EMA issued DHPC for Lomitapide
European Medicines Agency (EMA) has published Direct healthcare professional communication (DHPC) contains important information for healthcare professionals prescribing, dispensing or administering the […]
