Pharmacovigilance is all about striking a balance between making new medicines available for patients as early as possible still ensuring sufficient information on a product's quality, safety and efficacy is known.
Safety in the science, safety in the process
The overarching aim of pharmacovigilance (PV) is to protect public health. It starts with an intimate understanding of human biology and the mechanism of action your product relies on, to assess and mitigate any trial and treatment related risks. But it is equally about the systems and processes you as a sponsor apply to monitor and manage your product’s benefit / risk profile once it is on the market.
Understanding risk is managing risk
Safety is not absolute and there is never a situation without any risks. The way to advance clinical and scientific safety is by applying a risk-based approach. Adequately informed, a risk assessment of your program will inform you, not just where you may have the greatest clinical risks, but how to drive your development plans with the right priorities and mitigating measures in place.
At NDA we apply a risk-based approach in many aspects of drug development. From early immunogenicity risk assessments to the Risk Management Plans (RMP) that foster the PV practices surrounding the marketed product, we adopt an understandable, yet comprehensive risk-based approach to help you make the right decisions.
The devil is in the… process
Many accelerated pathways to market come with conditions – activities you must carry out post approval to demonstrate your claims. Agreeing the most appropriate measures with the regulatory agencies can be a factor significantly affecting your operation, and your bottom line, for years after you’ve been granted your marketing authorisation. NDA will make sure your commitments are clinically meaningful, yet practically feasible and efficient to implement.
Even when there are no specific strings attached you must be prepared to have a surveillance system, ruled by your Pharmacovigilance System Master File, in place. This will ensure that all meaningful safety signals are caught, assessed and appropriately responded to. Pharmacovigilance experts in NDA were there from the beginning, supporting the implementation of the PV regulation in Europe and have since been helping clients all over the world to scratch build, expand and globalise their PV systems. We do this conscientiously and efficiently, ensuring you build the system that is suitable for your products and the markets where they are sold.
To help us in this process we have a full offering of inspection readiness services where our auditors support you in identifying any shortcomings, before the agency inspectors do. It is these processes, diligently managed, that will ensure you leverage your products full financial potential once it hits the market, while ensuring the safety of all the patients that rely on your product for their treatment.
Our services include
- PV Strategic Advice
- Development Risk Management Plans
- PV & GCP Inspection Readiness
- Mock Inspection
- Risk Management Plan
- EU QPPV Services
- PSUR/PBRER authoring