SAFETY RISK MANAGEMENT
SAFETY RISK MANAGEMENT AND PERIODIC REPORTING FROM SAFETY REVIEW BOARD TO LOCAL PHARMACY
SAFETY RISK MANAGEMENT AND PERIODIC REPORTING
Enables global / HQ as well as local science units to maintain overview of Risk Strategies, RMPs/RPDs, PSURs/DSURs, RMMs and risks, in an easy and structured way through a web browser
Facilitates that the process occurs smoothly and without duplication of effort. A workflow ensures that each party will review and input changes – also Tracks compliance to the process/timelines for document creation.
Blocks usage of risks outside the strategy remit, i.e. enforces global acknowledgement of local deviations
Scheduling available to automatically task periodic reviews
Be inspection-ready with reports that demonstrate that the documents are created and distributed timely, in a PSMF annex ready format
Maintain a set of document templates that can be used for creation – and auto-populate data into documents from HALO PV
Is GxP validated* and ready to use in the cloud
*Validation package provided with documented proof of execution of test cases according to Insife’s standard process configuration. Additional validation activities may be needed to satisfy needs for your organization.
IMPROVING THE PROCESSING OF ADVERSE EVENT DATA BETWEEN LOCAL AND GLOBAL ACTIVITIES.
Safety risk management (SRM) of drugs, biologics and devices is an evolving discipline.
Whilst being at the very heart of pharmacovigilance (PV), the most predominant tools for
SRM is spreadsheets, perhaps because of diversity of activities and relatively low volumes of transactions, at least at the company HQ.
SRM is typically comprised of a hierarchy of processes and documents. From the very top is the Risk Strategy, which determines the core nature of how the company approaches risk management for a particular compound or product. One step down, the Risk Management Plans and other Risk management documents are created to satisfy the need for explaining and agreeing the approach for pharmacovigilance activities to specific markets. Some create “core” documents that are then modified to local markets. Finally, in the process of entering a market, Risk Minimization Measures / Regulatory Commitments (RMM) are typically surfacing at a local level, to adapt to further requirements by Authorities. The identified risks themselves is of course the central component that reaches across all these documents. Maintaining a good overview of the utilization of risks in global and local documents can be surprisingly challenging. A typical consequence of not keeping a well-managed risk register is that legacy
definitions of risks or non-corporate level risks emerge in local documents. Finally, periodic reporting is a timebound representation of your understanding of those
risks, often against the product benefits.
We acknowledge that managing all this is difficult. Therefore, we created a tool to allow you to manage your efforts and their inter-linkages, from strategy to local activities. It is called HALO PV.