REQUIREMENT INTELLIGENCE

WORRIED ABOUT HOW TO KEEP UP TO DATE WITH GLOBAL PV REGULATIONS AND REQUIREMENTS?

REQUIREMENT INTELLIGENCE

 

  • Enables local operations to maintain overview of requirements across ICSRs, PSMF/PV system, QPPV, Risk/periodic reporting, IRB/ethics committees, 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

  • Integration to your safety database, e.g. Argus Safety, to auto-configure reporting rules for ICSR distribution

  • Share blinded regulatory intelligence data with other pharmaceutical companies to ensure common practice

  • Scheduling available to automatically task periodic reviews

  • Tracks compliance to the process

  • Be inspection-ready with reports that demonstrate that the requirements are managed and in effect

  • 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 MANAGEMENT OF REQUIREMENTS ON A LOCAL TO GLOBAL SCALE

The global environment for pharmacovigilance (PV) is becoming increasingly diversified and complex. Europe, USA and Japan are pushing out regulatory changes that have impact on pharmaceutical and biotech companies every year. Additionally, other regions and territories are also becoming increasingly active, across China, India, Arab League, South/Latin America to name but a few. It is expected that your company is compliant with PV regulations in all the markets you have a presence in, for clinical as well as post-marketed product operations – but it can sometimes be difficult to account for the local requirements, especially if cited in a local language.

 

From the actual identification of a regulation change, to the assessment to actual implementation in your PV system, there may be a number of processing bottlenecks that can lead to compliance issues e.g.underreporting of adverse events (ICSR) from local markets or presence of a local QP.

Dealing with all this information often ends up being a manual management task involving a myriad of emails and complex spreadsheets. The risk of failure is high in this scenario, e.g. in producing a complete overview and adequate ICSR distribution.

 

Standard Operating Procedures (SOP) and agreements can be pushed on to enforce all your stakeholders to get the requirements to you, but our experience as consultants tell us that this is a fragile construct with multiple points-of-failure. Knowing the importance of complying with regulations in this area, we have therefore invested in making a PV tool to improve the management of requirements on a local to global scale and ensure adequate reporting. It is called HALO PV.

© 2020 Insife