Regulatory Oversight and Compliance

Bridging Gaps and Investing in Change

January 03, 2024

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

Developing an Optimized Risk Assessment Portfolio—The Quality Risk Management Master Plan

January 03, 2024

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

Bringing Collaboration to the Horizon Once More

January 03, 2024

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

Proving It’s Clean with Analytics

January 02, 2024

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

Finalizing the European Health Data Space

January 02, 2024

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

European Medicines Regulatory Network on Track to Meet Goals

December 27, 2023

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

A Record Year for Disease Elimination

December 26, 2023

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

FDA Publishes Guidance on Real-Word Data

December 21, 2023

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.

EMA and FDA Answer Questions About Breakthrough Therapies

December 21, 2023

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

EMA Publishes Guide for Use of AI in Medicine Regulation

December 18, 2023

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