Since 2012, the role of the Risk Management Plan (RMP) has gained huge importance, with the requirement that every new medicinal product needs to have one.
The DSRU can assist in various activities in this area, including:
- Writing the risk management plan, or assisting in its development
- Designing protocols for studies that are scientifically robust and meet regulatory standards (we have never had a study design proposal refused by PRAC)
- Conducting post authorisation safety studies to evaluate safety, post authorisation efficacy, or the effectiveness of risk minimisation – or we can simply provide practical guidance on how to do this
However, risk management doesn’t end there! It’s a dynamic process, and so as time goes on, companies need to be able to manage new and emerging safety data on their product, which may impact on the benefit risk assessment, and/or require further thinking on risk minimisation. We can help by:
- Doing benefit risk assessments at various times in the product life cycle
- Evaluating safety signals
- Signal detection
- Collating data
We understand regulatory expectations in these areas.
Ultimately the aim of risk management is to:
Ensure benefits exceed risk by the greatest possible margin
The DSRU can help you do this…..
Examples of studies designed and conducted by us as part of a RMP:
In primary care using information provided by General Practitioners (GPs):
- Asenapine – a modified prescription-event monitoring study designed to examine the safety of this atypical antipsychotic. A sister study was undertaken to examine the safety and utilisation of this drug when it is prescribed in specialist care.
- Rivaroxaban – a modified prescription-event monitoring study designed to examine safety of this oral antithrombotic agent. A sister study (ROSE) was undertaken to examine the safety and utilisation of this drug when it is prescribed in secondary care.
- Fentanyl buccal tablets
- Testosterone patch (Intrinsa)
Using information provided by Specialists:
Observational Assessment of Safety in Seroquel (OASIS) – completed
Observational Safety Evaluation of Asenapine (OBSERVA) – completed
Rivaroxaban Observational Safety Evaluation (ROSE) – completed
The Rivaroxaban Observational Safety Evaluation post-Acute Coronary Syndrome (ROSE ACS) Study – currently recruiting