Pharmacovigilance and medical information

A medical information division is responsible for providing scientific, product and therapeutic expertise to health care professionals and patients to support them in making decisions.

Pharmacovigilance activities relate to the detection, evaluation, understanding and prevention of adverse drug reactions or any drug-related problems.

Medical information and pharmacovigilance activities are closely related. Medical information requests often contain for example off-label use or exposure during pregnancy, which are considered adverse events and need to be reported to the pharmacovigilance department. On the other hand, adverse event reports often contain questions regarding the product and its shelf life, correct use, available safety information,...

Both services are extremely important in the pharmaceutical industry, as pharmacovigilance ensures the safety and wellbeing of patients throughout the entire drug life cycle. It is an obligation imposed by authorities to continuously monitor side effects of both experimental and marketed drugs, by collecting data and reporting to health authorities on a regular basis. The safety profile of a medicinal product is continuously evolving, and PV helps to inform HCP and patients (with SmPC and PIL) as well as positioning drugs on the market.

The performance of medical information is also legally required by the authorities for every marketing authorization holder. Educating HCP (and patients) regarding the existing product data enables them to make informed decisions. The medical information team provides knowledge and expertise on correct product use and administration, available safety information, literature data and many more.

Combining both medical information and pharmacovigilance services, AxTalis is an ideal partner to meet regulatory obligations and customers’ expectations.