Quality Systems

Articles

EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022. 

EC Confirms Go-Live Date for Clinical Trials Information System

Bristol Myers Squibb has been granted approval by the European Commission for Opdivo (nivolumab) as an adjuvant treatment

BMS Gains European Approval for Opdivo

EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.



CHMP Approves Manufacturing Scale-Up for Spikevax

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Pharma and biotech supply chain companies are working together to help facilitate the transition of the pharma industry to net zero emissions compliance.

Working Towards Zero Emissions

The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.

EMA Approves Scale-Up Process for Janssen COVID-19 Vaccine

The draft revisions of Annex 1 are driven by a quality risk management approach and will provide more clarity and detail for manufacturers.

Considering Annex 1 Revisions: Expert Insights

Podcasts

Pharmaceutical Technology discussed the potential increased risk of counterfeit medicines in the UK post-Brexit and how blockchain could be a useful tool to tackle the issue.

Tackling Counterfeit Medicines

EMA's recent positive opinion for a recombinant vaccine for rabbits developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, should push the full commercialization of the platform forward.

EMA Issues Positive Opinion for CrisBio Developed Vaccine, Validating the Platform

As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.

EU Regulators Recommend Not Releasing Batches of Janssen COVID-19 Vaccine

The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.

Regulatory/GMP Compliance, Europe