"The potential to use artificial intelligence methods increasingly for the analysis of the increasing amounts of pharmacovigilance data is well understood and many companies are moving (or planning to move) there, and we can predict that routine tasks in pharmacovigilance will in the future be increasingly automated. It will be crucial, however, for regulatory authorities to very clearly provide a position about the use of AI as well as the acceptable level of quality from AI applications. But in parallel with the shaping of those definitions, given the massive increase in their AE case workloads that most companies are currently experiencing, the industry will out of necessity proceed swiftly with the adoption of AI and cloud technologies to reduce their costs and increase their efficiencies. "Like other industries, the pharmaceutical business and in particular the pharmacovigilance field will see a massive change in their processes in the near future, away from tedious, repetitive manual tasks towards a better utilization of scarce resources, in particular medical and scientific knowledge, for value-adding tasks. It is imperative for all stakeholders – industry, service providers and regulators – to provide an environment in which such a transformation can take place without ever compromising public health or the safety of the individual patient, and ideally providing additional benefit for patients." A quote from Addressing the Data Challenges [...]