EU Pharmacovigilance legislation
Since the revised EU Pharmacovigilance legislation came into force in 2012, it has become a statutory requirement for pharmaceutical companies to produce risk management plans (RMPs) for a broad range of medicines. The DSRU team is heavily involved in both advising on and conducting studies which are part of RMPs. In addition, our team has experience in conducting studies to monitor the effectiveness of risk management measures.
The DSRU has many years’ experience of conducting studies which are used as part of a RMP, including cohort studies conducted in primary or secondary care settings, registries, case-control studies, studies based on a number of pharmacoepidemiological databases, and systematic reviews. Our expert team comprises epidemiologists, physicians, pharmacists, biomedical scientists, statisticians, a data manager and trained coding staff.
Complete study package
We offer a complete study package, including the following:
- Consultation and advice on risk management strategy
- Design the study protocol taking account of any specific regulatory requirements
- Write a statistical analysis plan
- Request ethics approval and NHS R&D approval where necessary
- Conduct the study
- Analyse and interpret the study data
- Write interim and final study reports
- Publish the study in high impact peer reviewed scientific journals
- Communicate findings at national and international conferences
Studies utilising a range of data sources
In many cases, where the DSRU team consider that the best option for a risk management study is to be conducted using other sources, such as CPRD, they provide advice and have the capabilities to advise on or conduct such studies.