ECFS 2020 - Optimizing pharmaceutical care in cystic fibrosis

European Cystic Fibrosis Society   283  OPTIMIZING PHARMACEUTICAL CARE IN CYSTIC FIBROSIS PATIENT REGISTRIES IN PHARMACOVIGILANCE CHAPTER 16 5 Perspectives Post-marketing drug monitoring (phar- macovigilance) is an important task for patients, caregivers, industry and regula- tors. Patient registries like the ECFSPR are qualified to contribute to active pharmacov- igilance surveillance in Europe, however this places stress on infrastructure, govern- ance, data quality management and finan- cial resources. The transformation from a mainly commitment-based research collab- oration to a high-quality post-authorization database for regulatory decision-making is challenging. Continuous dialogue with patients is critical. The commitment of patients, collaborating partners like national registries and individual centers, MAH and regulators is needed to build up a construc- tive relationship to fulfill the goals of better safety and efficacy of new treatments. Recently, the first post-marketing studies have been published, mainly from the UK and US, and the first multinational post-mar- keting studies for CF across multiple coun- tries in Europe have been requested by the EMA. These studies will be the proof- of-concept for this ambitious concept. We hope that this will pave the way to a long-term sustainable and independent patient-registry database in Europe, which can be adapted to future needs and fulfill the goals to contribute to pharmacovigi- lance as well as epidemiology and research.