Pharmacovigilance is all about safer and more effective use of drugs and medical devices throughout the products’ life cycles by the detection, collection, assessment and management of adverse reactions or effects.
Our Pharmacovigilance department has experience of investigational medicinal products, advanced therapy medicinal products (ATMP) and medical devices in a wide range of indications and areas of use. The team carries out their work in accordance with good pharmacovigilance practice (GVP) and related regulations and directives
Every medicinal product and medical device must have a satisfactorily completed clinical trial/investigation program establishing acceptable evidence of safety and efficacy before achieving marketing approval and or CE marking. Our Pharmacovigilance team can offer full guidance in identifying your company’s specific needs regarding required pharmacovigilance activities, safety management and medical monitoring as well as tailor our services to provide suitable and reliable support to your team throughout the development process.
Cornelia Lif-Tiberg, MD, Director Pharmacovigilance