An easy way of publishing your relevant EU press releases.

Smart Pharmacovigilance Essential for Patient Safety


29 Jan 2020


Health & Consumers

Amsterdam, 29 January 2020

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 HovenMedicines 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.”

About Medicines for Europe

Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe, and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at and on Twitter @medicinesforEU.


Specialised Nutrition Europe
Communications & Public Affairs Trainee
Membership intern
Friends of the Earth Europe
Finance Manager
The European Network Against Racism
Budget & Finance Officer
International Dairy Federation
Content Creator
EERA - The European Energy Research Alliance
Communications & Policy Internship
Peace Brigades International
Finance Compliance Consultant