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REQUIREMENT INTELLIGENCE

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

Requirement Intelligence at a glance
  • Manage all local requirements and obligations for Authorities as well as partners and affiliates, across ICSRs, PSURs, SUSAR reporting etc.

  • Auto-build “reporting rules” and auto-schedule activities according to them

Key features​

  • Maintain overview of global requirements (“obligations”) towards partners and authorities. Allow for local personnel to do the updates of e.g. a spontaneous ICSR rule. An approval from central is potentially all it takes to auto-configure your safety database​

  • Auto-generate rules in the safety database​

  • Auto-schedule to other modules of HALOPV e.g. Aggregate reporting or Submissions for generation and tracking of activities​

  • Link to Submissions, i.e. track the number of actual reports sent out based on the requirement​

  • Link to SDEAs for establishing a loop between what is in in the contract and what is implemented in practice​

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.