Pharmacovigiliance

Our pharmacovigiliance department is engaged in the collection and analysis of data submitted by authorized entities of adverse drug reactions (ADR).

In 2013, EU law made it possible for patients to report adverse drug reactions. Funding from the European Union made it possible to create an electronic platform dzialanianiepozadane.com, for patients and healthcare professionals to quickly report adverse medication reactions of prescription products, diet supplements, or other medical products.

Because Poland came in at the bottom end in the EU of reported adverse drug reactions (0,02% of the ADR reported to the WHO in 2013). Our initial ambition was to improve the safety of patients in Poland. Since then we have sought to offer our expertise to others with a similar need.

Within the site pharmacovigiliance we offer among others:

• Pharmacovigiliance service
• Access to the register of www.adrreporting.com
• NDL s reporting service through our platform which facilitates the export of electronic data
• Preparing CIOMS forms
• Monitoring of the international press in the fields relating to pharmacovigiliance
• Preparing SOPs for non-interventional, PASS, and PAES research
• Providing information on adverse drug reactions relating to active substances and medicinal products compatible with the customer’s portfolio
• PV audits
• PV training by experts with years of experience in the field of pharmacovigiliance