EMA pub's safety monitoring plan and guidance on risk mgmt
Nov 14, 2020 18:18:02 GMT 7
smokie36 likes this
Post by rubl on Nov 14, 2020 18:18:02 GMT 7
Even with all tests and precautions it is still necessary to keep track of who gets inoculated and the short, medium and long term result.
"EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines
EMA and the national competent authorities (NCAs) in EU Member States have prepared a PDF iconsafety monitoring plan for COVID-19 vaccines . The plan outlines how relevant new information emerging after the authorisation and uptake of COVID-19 vaccines in the pandemic situation will be collected and promptly reviewed.
The safety of COVID-19 vaccines will be monitored according to the guidance set out by EMA and NCAs in the good pharmacovigilance practices (GVP), that applies to all medicines. In view of the extraordinary circumstances, though, EU authorities have planned several activities that will apply specifically to COVID-19 vaccines.
Through the implementation of these activities, the EU medicines regulatory network will assess any safety data emerging from a range of different sources (spontaneous reporting, observational studies, etc.). Any potential safety concerns identified will be addressed by taking appropriate regulatory action to safeguard individual and public health and communicating with the public in a transparent and timely manner."
www.ema.europa.eu/en/news/ema-publishes-safety-monitoring-plan-guidance-risk-management-planning-covid-19-vaccines
"WELCOME TO THE EUROPEAN MEDICAL ASSOCIATION, FOUNDED BY DOCTORS FOR DOCTORS…
Created in 1990 by doctors from the 12 member states, the European Medical Association was established as an “international foundation pursuing a scientific aim” according to the Belgian law dating 25/10/1919. It is a unique, independent non-profit organisation, which offers every European Community doctor the opportunity to:
. Join a European network of doctors
. Add a European dimension to their professional and social life
. Actively influence the development of European Health Care"
emanet.org
"EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines
EMA and the national competent authorities (NCAs) in EU Member States have prepared a PDF iconsafety monitoring plan for COVID-19 vaccines . The plan outlines how relevant new information emerging after the authorisation and uptake of COVID-19 vaccines in the pandemic situation will be collected and promptly reviewed.
The safety of COVID-19 vaccines will be monitored according to the guidance set out by EMA and NCAs in the good pharmacovigilance practices (GVP), that applies to all medicines. In view of the extraordinary circumstances, though, EU authorities have planned several activities that will apply specifically to COVID-19 vaccines.
Through the implementation of these activities, the EU medicines regulatory network will assess any safety data emerging from a range of different sources (spontaneous reporting, observational studies, etc.). Any potential safety concerns identified will be addressed by taking appropriate regulatory action to safeguard individual and public health and communicating with the public in a transparent and timely manner."
www.ema.europa.eu/en/news/ema-publishes-safety-monitoring-plan-guidance-risk-management-planning-covid-19-vaccines
"WELCOME TO THE EUROPEAN MEDICAL ASSOCIATION, FOUNDED BY DOCTORS FOR DOCTORS…
Created in 1990 by doctors from the 12 member states, the European Medical Association was established as an “international foundation pursuing a scientific aim” according to the Belgian law dating 25/10/1919. It is a unique, independent non-profit organisation, which offers every European Community doctor the opportunity to:
. Join a European network of doctors
. Add a European dimension to their professional and social life
. Actively influence the development of European Health Care"
emanet.org
