Consulting on Risk Management
Based on its vast experience, the DSRU team provides advice on strategies and options (including the most suitable study designs) for Risk Management Plans in the EU. The DSRU has experience in handling a very broad range of products, from those that are widely used to small niche highly specialised medicines. The DSRU has a proven track record of providing impartial advice.
The DSRU scientific team comprises epidemiologists, clinicians, pharmacists, biomedical scientists and statisticians. Through our experience of conducting studies of all sizes, we have gained a thorough understanding of the national and international regulatory requirements. Since the EU Pharmacovigilance legislation came into force in 2012, it has been a statutory requirement to produce risk management plans for medicines. DSRU studies may be based on the DSRU’s data sources or other sources in Europe. They can be designed to address the requirements of risk management plans. We guide all concerned through the associated regulatory processes of such studies.
Further information about our consulting capabilities is available via the links in the panel on the left.