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Pharmacovigilance now and in the future – Current topics of the World Drug Safety Congress Europe

The World Drug Safety Congress Europe was arranged as a virtual event on 14–16 October 2020. The event was attended by hundreds of drug safety experts from Europe and around the world. Current topics related to pharmacovigilance in Europe and elsewhere were covered extensively. Future trends were also emphasised strongly in the discussion, especially with regard to the development possibilities introduced by new technological solutions.

Here are the highlights of the event as chosen by our experts:

1. Could it be possible to focus more on individuals in pharmacovigilance?

In addition to the likelihood of the occurrence of an adverse effect, health care professionals and patients are interested in which patients are at particular risk of the adverse effect. More and more attention is being paid to treating patients as individuals and, consequently, there is demand for creating more individualised benefit-risk profiles for drugs. Creating more individualised safety profiles and providing patients with adequate information about the profiles would also support patients’ participation in making decisions concerning their treatment.


2. Demand for modern technology and new distribution methods in risk minimisation measures

An interesting subject of all drug safety forums is the distribution methods and effectiveness of “additional risk minimisation measures”. The following topics were discussed:

  • Traditionally used letters and other materials should be updated to more modern forms, such as videos/online training services/applications
  • Authorities should have a larger role in the distribution of materials and assessing their impact as the communication/information collection processes of authorities are generally considered to be more effective
  • The use of technological solutions in the distribution of materials should be developed further, for instance, by introducing mobile applications and various digital platforms
  • Using the services of patient/expert organisations more effectively in the distribution of materials is important


3. The COVID-19 pandemic highlights the importance of pharmacovigilance

Practically all parties possible from consumers to health care personnel, authorities, industry, media and politicians are interested in finding a cure for controlling and eradicating COVID-19. The development of a new drug/vaccine is largely based on the product’s benefit-risk ratio, and assessing this ratio is one of the key themes of pharmacovigilance.

The pandemic and its ramifications have set at least the following expectations for the pharmaceutical industry in controlling/eradicating the pandemic:

  • Accelerated research/marketing authorisation process and focusing resources on the most important themes.
  • Transparency in research schedules and the benefit-risk ratios of drugs.
  • Training on the development phases and safety analysis of new drugs, particularly for the media.


4. Artificial Intelligence (AI) has become an integral part of pharmacovigilance

There are various elements that support the use of automation in pharmacovigilance forums, such as the need to save data in a standard format and to analyse massive quantities of detailed data quickly, reliably and from multiple perspectives.

Many major pharmaceutical companies and service providers have invested heavily in automation, while several smaller companies are just learning about the basics of automation with possibly mixed feelings of elation and terror. At DRA, we are eagerly waiting to welcome our first robot colleague – more on that later!