Drug safety

Making drug safety a company-wide responsibility

Despite in-depth pre-clinical tests and clinical trials, and despite respecting strict regulatory manufacturing standards, side-effects can occur with medicines because patients can react differently to the disease and its treatment. We have well-established systems to closely monitor these adverse events and react rapidly to them.

The risk of a potential drug failing to progress through development to market is significant. Numerous quality, safety and clinical efficacy thresholds have to be passed. At UCB, we follow the strict regulatory standards for drug manufacturing to ensure that our drugs meet the legal and regulatory safety, quality and efficacy requirements.

Like other biopharmaceutical companies, UCB receives thousands of adverse event reports every year concerning our drug products, which are reviewed internally and provided to the governing regulatory authorities. Our safety teams use various tools to identify potential safety issues that could be related to adverse events, which may or may not be associated with our medicines.

Together with other departments, our safety teams draw up patient-risk management plans.

Providing patient-risk management plans

Patient-risk management plans describe potential safety issues and the necessary actions and timelines required to reduce potential risks to patients throughout the entre lifecycle of each medicine.

UCB provides these plans to health authorities as part of its submission for approval to market new medicines. These plans, which are also applied to first-in-man studies, are regularly reviewed and updated with new safety data as scientific and medical knowledge of the medicine’s safety profile progresses.

Investing in new techniques

Alongside other biopharmaceutical companies, we are investing in new techniques that will help improve patient safety and detection of possible side effects at an early stage. For example, we are developing technologies like safety biomarkers imaging techniques, computer modelling and simulation linking large sets of preclinical and clinical data. Much of this work is carried out through partnerships such as the European Union’s Innovative Medicines Initiative (IMI).