Starting from the development of any new potential drug and all along its life cycle, our objective is to ensure that Zambon products are safe.
Before a new Zambon drug is approved and enters the marketplace, it is assessed though rigorously controlled pre-clinical and clinical studies, which provide critical information on its safety and efficacy. Furthermore, once the drug is available for widespread use, Zambon maintains a set of ongoing explicit and comprehensive processes and procedures aimed at ensuring that any new potential safety issue is systematically detected and communicated to regulators, so that appropriate decisions and actions are taken.
Zambon has a global pharmacovigilance system in place, with a dedicated team of scientists and physicians across the world.
To ensure patient safety during all stages of the product lifecycle, Zambon has instituted:
A central Drug Safety Unit located in Bresso (Milano), which collects all safety information reported worldwide and monitors the risk-benefit profile of Zambon products, in order to confirm their positive therapeutic effects in relation to their risks as regards to patients’ health
Local Pharmacovigilance Operating Units in each subsidiary, which collect, record, analyze and communicate safety information reported by patients, clinical trial investigators and healthcare professionals. In addition, these teams interface with local health authorities.