Quality Systems

Revolutionary therapies restructure pharmaceutical manufacturing.

European bio/pharma companies have no choice but to invest and adapt to the evolving industry needs.

A thoughtfully constructed QRM Master Plan translates the strategy and enables a risk-based approach.

UK scientists are once again able to participate in the Horizon European research programme thanks to a deal struck in 2023.

Analytical methods and tools play a pivotal role in cleaning validation.

The EHDS aims to increase access to health data, but how will it impact pharma?

Clinician-Scientists are vital innovation spark plugs, accounting for 40% of Nobel awards in Physiology or Medicine, and two thirds of Big Pharma CSOs.

The midterm report of the European Medicines Agencies Network Strategy finds that the network has strengthened and is on track to achieve its objectives.

WHO provides a look at the world’s health as the agency turns 75.

The final guidance document provides recommendations for designing a new registry or using an existing registry to support decisions regarding safety and effectiveness of a drug.

The agencies published a joint guidance document regarding quality development for breakthrough therapies and PRIME programs.

The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.

The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.

RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.

The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.

Sanofi has issued a statement expressing its disappointment with FTC’s decision to block an exclusive licensing agreement with Maze Therapeutics for a rare disease drug candidate.

Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.

The product is being voluntarily recalled because of powder leakage due to seal integrity issues.

The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.

The medicines, levetiracetam and clobazam, may a cause life-threatening reaction to patients if not caught and treated quickly.

Novartis has issued a nationwide voluntary recall of two lots of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL because of crystallization issues.

The bio/pharmaceutical industry is struggling with the challenge of staffing and training.

Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.