A Continuing Paradigm Shift

Looking back on our company's activities over the last few years, we can observe notable changes which are a testimony to the ever-growing recognition of the importance of the safety of therapeutic products (drugs, devices, vaccines, combination products):

· We are being contacted more and more by companies very early in development who want to ensure that PV will be supporting their progress to CTA and first patient in. This is a radical change from the previous mindset of bringing PV as an afterthought only when reaching Phase II or later. It means that the Biotech world is aware that PV is a key element of the early development strategy.

· We see a new generation of very motivated and knowledgeable PV experts around us. They did not come to PV by accident but are driven by passion for the PV science and the importance to the health care environment. This level of energy and knowledge will continue to drive phenomenal changes for the decades to come. Pharmacovigilance can get further integrated within Pharma and it will.

· Access to PV knowledge has reached another dimension, thanks to technology and increasing collaborations between regions/countries. Understanding regulatory expectations is becoming easier with multiple guidances and Q&A documents, including CIOMS works. From a strategic standpoint, it makes it easier to have a global approach to dealing with challenges while understanding the local needs. International harmonization will continue to progress.

Pharmacovigilance and adverse drug events matter more than ever.