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November 24, 2020
HMA and EMA have released a joint statement on the appropriate route for companies to submit marketing authorization applications and the approval processes for vaccines.
November 18, 2020
The agency’s safety monitoring plan outlines how information that emerges after the authorization of COVID-19 vaccines will be collected and reviewed.
The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.
The agency marked the annual European Antibiotic Awareness Day with the launch of a social media campaign highlighting the prudent use of antibiotics.
November 04, 2020
Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress.
November 03, 2020
The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.
An optimal engineering design is crucial for aseptic operation and cleaning.
Bio/pharma continues preparations for a no-deal scenario as time for the UK and EU to agree upon a new deal runs out.
November 02, 2020
The agency is balancing a variety of important issues including the review of COVID-19 vaccines.
Industry wants clarification on compliance following the end of the Brexit transition period.