Regulatory/GMP Compliance, Europe

EMA Issues Safety Monitoring Plan for COVID-19 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.

EMA Publishes Risk Management Guidance for COVID-19 Vaccines

November 18, 2020

The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.

EMA Raises Antibiotic Use Awareness

November 18, 2020

The agency marked the annual European Antibiotic Awareness Day with the launch of a social media campaign highlighting the prudent use of antibiotics.

Technology’s Role in QA/QC

November 04, 2020

Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress.

EDQM Releases Document on Recombinant Viral Vectored Vaccines for COVID-19

November 03, 2020

The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.

Understanding the Impact of Annex 1 on Isolator Design

November 03, 2020

An optimal engineering design is crucial for aseptic operation and cleaning.

Dealing with No Deal

November 03, 2020

Bio/pharma continues preparations for a no-deal scenario as time for the UK and EU to agree upon a new deal runs out.

COVID-19 Stresses EMA Resources

November 02, 2020

The agency is balancing a variety of important issues including the review of COVID-19 vaccines.

Calling for Clarity

November 02, 2020

Industry wants clarification on compliance following the end of the Brexit transition period.

EMA Implements Transparency Measures for COVID-19 Medicines

October 30, 2020

The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.