Can EMA's Regulatory Science Strategy Meet Medicine's Major Challenges?

[...]the report, which covers both human and veterinary medicines, devotes relatively limited space to ways of using regulatory science to deal with pandemics such as COVID-19, particularly the emergency development and mass-scale manufacture of vaccines. [...]to deal with the outbreak, EMA has impl...

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Bibliographic Details
Published in:Pharmaceutical technology Europe 2020-05, Vol.32 (5), p.6-8
Main Author: Milmo, Sean
Format: Article
Language:English
Subjects:
Collaboration
Consumer organizations
Coronaviruses
COVID-19 vaccines
Epidemics
Good Manufacturing Practice
Manufacturing
Pandemics
Science
Stakeholders
Task forces
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Summary:[...]the report, which covers both human and veterinary medicines, devotes relatively limited space to ways of using regulatory science to deal with pandemics such as COVID-19, particularly the emergency development and mass-scale manufacture of vaccines. [...]to deal with the outbreak, EMA has implemented its 2018 Health Threat Plan by setting up a COVID-19 EMA Emergency Task Force (ETF), which will assist in the development, authorization, and safety monitoring of therapeutics and vaccines to deal with the pandemic (2). EMA, "Mandate, Objectives, Rules, and Procedure of the COVID-19 EMA Pandemic Task Force (COVID-ETF)," ema.europa. eu (Amsterdam, 31 March 2020).
ISSN:1753-7967