SAFETY RISK MANAGEMENT
SAFETY RISK MANAGEMENT AND PERIODIC REPORTING FROM SAFETY REVIEW BOARD TO LOCAL PHARMACY
Safety Risk Management at a glance
Global risk register
Manage risk strategy, Benefit-Risk evaluations, risk management documents, risk minimization measures (also locally) and other activities – global as well as local
Build up your universe of risk components in one place, from Risk registration, Risk Management Strategies to Plans, to Minimization measures and other activities – also locally - Built around a powerful workflow engine that will allow for the review, approval and management
Auto-generate RMPs, format using Word templates. Template based document creation but also with “text snippets” that allow controlled introduction of non-core template text
Built-in charts including Gantt overview of activities. Also monitor timeliness across all deliverables
Link to Signal Management process ensures that risks are monitored and to Requirements Intelligence to ensure that RMPs are timely against regulations
Simple and configurable user interface means less training needed and quicker to go live
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.