Special Section: Pharmacovigilance

Preamble and Introduction
Dr. J. Vijay Venkatraman standing behind a proctor and giving a speech

ear Global Forum Readers,

As a pharmacovigilance aficionado and an active contributor to a variety of DIA initiatives over the past 15 years, I consider it one of my greatest honors to have been invited to serve as the Editor for this Special Section of Global Forum on Pharmacovigilance. I take this opportunity to thank Dr. Alberto Grignolo, Global Forum Editor-in-Chief, and Chris Slawecki, Senior Digital Copy Editor, DIA Scientific Communications, for this invitation to contribute to this vital topic.

Pharmacovigilance, a term which used to be pronounced often only by those working in the discipline, has almost become common parlance during the past 18 months or so, thanks to the pandemic! Never before has pharmacovigilance demanded more attention from the public than it does today, given the avalanche of discussions we have seen on the safety profiles of medicines used for treating COVID infections and then on the benefit-risk potential of COVID vaccines. Within the pharmacovigilance fraternity, this newfound recognition for the phenomenal work that has always been done has indeed induced cheer and optimism despite the gloom we all went through during the dark days of the pandemic.

But it is worthwhile to recall that pharmacovigilance as a domain was already at a crossroads even before the novel coronavirus struck. Years of deliberations on several global pharmacovigilance concepts such as harmonization of regulations, automation of processes, compliance challenges, fast-growing national pharmacovigilance programs worldwide, impacts of geopolitical decisions like Brexit, adoption of new business models in outsourcing, emergence of new hubs for drug safety operations, and technological revolutions with promising future, etc., had led to significant developments in the drug safety space, which were further studied and leveraged properly during the pandemic.

We have borne two fundamental tenets in mind while choosing which submissions should be featured in this special edition of Global Forum, namely the “spirit of innovation” and “relevance at a global level.” This does not mean that routine pharmacovigilance activities for established drugs do not reveal critical signals anymore, or that locally effective innovative measures in drug safety are not important. We have only tried to achieve just the right balance between “what is new?” and “what is useful?” for any Global Forum reader, hailing from any part of the world, regardless of how deeply they are involved in pharmacovigilance.

From the large number of positive responses that we received from many countries for this special section, we are confident that the current and forthcoming issues of Global Forum will prove to be a feast for readers interested in pharmacovigilance, whether or not this is their specialty.

With thanks and regards,

Dr. J. Vijay Venkatraman
Special Section Editor