PASS, PAES, DUS Studies
- New regulations impose the responsible entity the obligation to conduct such research, as a condition of authorization, or at any other time, when concerns or safety issues need to be investigated.
- We are the most experienced in Poland in organizing and conducting safety research such as PASS, PAES, and DUS.
- For over 17 years, Europharma has supported the activities of pharmaceutical companies in monitoring the safety of medicinal products after authorization and obtaining complete and reliable data after entering the market, by conducting safety research (PASS – post-authorization safety study) and effectiveness (PAES – post-authorization efficacy study), and drug utilization (DUS – drug utilization study).
- We have done almost 50 such research projects, with a total population of about 500,000 patients.
- In our activities the patients’ welfare is paramount. From this idea was born the conception of creating the universal system that allows the reporting of adverse drug reactions not only by healthcare providers, but also by patients themselves.
- Safety and proper compliance with the law are of great importance to us, so in order to assure compliance with all standards of the European Union, as well as in host countries, we have adopted internal procedures prepared with close consultations of leading law firms specializing in pharmaceutical law.