A smart digital pharmacovigilance system should:

  • Focus resources on safety rather than administration.
  • Promote work-sharing to leverage and maximise the existing capacity of industry and regulators.
  • Use automation, robotization and Artificial Intelligence (AI), to accelerate the assessment of the medically relevant information collected through the EU pharmacovigilance system

Medicines are developed and manufactured to help patients so, it is important to monitor their use for potential adverse events through pharmacovigilance.

At the 13th Annual Medicines for Europe Pharmacovigilance Conference, stakeholders agreed that pharmacovigilance is not only mechanical exercise in regulatory compliance. Rather, smart pharmacovigilance should allow us to leverage the experience of the European Pharmacovigilance System, including the longstanding knowledge of the safety profile of well-established products and big data to optimise the use of our finite human resources.

Big data and globalisation offer opportunities to innovate in the pharmaceutical sector. Innovation also means finding new ways of making existing drugs and processes like pharmacovigilance deliver more for patients. Digital technologies increase available pharmacovigilance data, but this can only be put to good use if essential and non-essential information is filtered by the EMA pharmacovigilance system before review.

By building on successful industry-regulator cooperation projects such as the HaRP project for risk management, we can dramatically improve synergies in other areas like electronic product information or streamlining communication with healthcare professionals.

Adrian van den Hoven, Medicines for Europe Director General commented: “Europe has one of the most sophisticated pharmacovigilance frameworks in the world. But we should not rest on our laurels. Smart pharmacovigilance requires us to improve our capacity to filter the massive information available so that we can focus on what matters most to patients.”

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