Important Medical Event (IME) list In the Pharmacovigilance process, to facilitate the seriousness assessment of a reported event, the safety team should […]
Blog Archive
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Ethiopia Pharmacovigilance guidelines
In September 2020, Ethiopian Food and Drug Authority issued Pharmacovigilance Directive in accordance with Article 71 sub article (2) of the Ethiopian […]
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Updates on labelling, package leaflet and variations (EMA)
On 09 Feb 2021, European Medicines Agency (EMA) has provided updates on labelling and package leaflet and variations. Here you can find […]
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GVP Module XVI Addendum II – Methods for effectiveness evaluation (Draft for Public Consultation)
On 01 Feb 2021, EMA has released a draft Regulatory and procedural guideline on “GVP Module XVI Addendum II – Methods for […]
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GVP Module XVI – Risk minimisation measures (Draft for Public Consultation)
On 01 Feb 2021, EMA has released draft Regulatory and procedural guideline on “GVP Module XVI – Risk minimisation measures: selection of […]
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Health Canada Open Consultation for Pharmacovigilance Professionals
Health Canada Open Consultation for Pharmacovigilance Professionals Health Canada announced a 90-day consultation for the revised guidance draft document: Reporting adverse reactions […]
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ANVISA PBRER list 2021 (Brazil)
ANVISA PBRER list 2021 (Brazil) Background In 2009, the first pharmacovigilance legislation at the national level was published in Brazil. On 22 […]
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CIOMS role in Pharmacovigilance
CIOMS full form is Council for International Organizations of Medical Sciences CIOMS is an international, non-governmental, non-profit organization CIOMS plays a vital […]
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Historical Evaluation of Pharmacovigilance
Historical Evaluation of Pharmacovigilance: We would be going through the origin and evolution of Pharmacovigilance to its present stage. Let’s start! On […]
