The regulatory world is rapidly evolving to shorten the review and approval process, moving toward more conditional approvals with restricted and controlled drug use. The field of combination products, with the limitless possibilities of smartphones, device technology, sensors and drug delivery systems is exploding. The ability to access massive datasets across different systems and populations is disrupting the existing approaches to data mining and pharmacoepidemiology.
The customization of benefit-risk at the individual level brings patient engagement activities and risk communication to a totally different way of thinking about benefit-risk and risk communication. In the meantime, the ever increasing dis-harmonization of safety requirements across regions and countries obliges pharmacovigilance organizations to constantly look for innovation, productivity and performance gains. These are some of the significant but very exciting challenges that makes pharmacovigilance such a fascinating domain, more than ever. The ability to understand the current trends and to brainstorm with key opinion leaders and colleagues are critical to preparing our minds and practices to this changing world.