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Our pharmacovigilance system is helping to ensure safer use of medicines.

Patient safety must always be the number one priority when providing access to pharmaceutical products – which is exactly why Centrient Pharmaceuticals has a pharmacovigilance system in place.

Pharmacovigilance is defined by the World Health Organization (WHO) as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem’. We teach our employees about the basics of pharmacovigilance to ensure that those who take our medicines do so safely.

'We provide the very latest drug information by implementing Good Pharmacovigilance Practices (GPP), as issued by the European Medicines Agency (EMA), and by immediately adapting to new releases when necessary', says Benedicte Hubrecht, Head of Regulatory Affairs for Final Dosage Forms at Centrient Pharmaceuticals. 'This enables us to determine any potential safety issues that may arise from literature screening, clinical studies or other market reports. Any relevant findings are subsequently included in the patient information leaflets we produce.'

In January 2018, for example, a Periodic Safety Update Report (a so-called ‘PSUR’) was submitted by Centrient Pharmaceuticals to the EMA for assessment of any new safety information related to atorvastatin. This assessment led to an update of the patient leaflet regarding the effects of the drug when taken with certain other medications.