Much more than ever before, I am delighted to greet you through this February 2023 edition of Oviya MedSafe‘s newsletter (the 123rd in the series since April 2012) that is being released soon after the 11th anniversary of Oviya MedSafe’s founding (on 14th March)! On this occasion, let me thank each one of you for your goodwill for Oviya MedSafe which has always encouraged us to work hard to raise and establish Oviya MedSafe as one of the leading global brands in Pharmacovigilance that it is today!
At this juncture, I wanted to touch upon a topic that has always been close to my heart and elaborate a bit on how Oviya MedSafe has approached it all the time. I prefer to call it ‘Pharmacovigilance Equilibrium‘. As you know, the word equilibrium could be defined as “a state of balance between opposing forces or actions”. Pharmacovigilance, by its very nature as an inexact science, is often subject to opposing forces or actions. In fact, the concept of benefit-risk balance itself stems from the desire to achieve equilibrium in the context of usage of medicinal products. While benefit-risk balance is a vast subject encompassing several fields, I wish to now focus on one specific aspect of equilibrium from a Pharmacovigilance operations’ standpoint.
When we carry out Pharmacovigilance activities in the industry with the aim of achieving regulatory compliance, we occasionally come across questions that have more than one reasonable answer. At times, none of these answers could be accurate or adequate. Sometimes, a solution that addresses one part of a problem may end up jeopardizing another. We all know that the relevant regulatory rules, widely accepted Pharmacovigilance guidelines, written procedures of the company (license-holder), contractual agreements between Pharmacovigilance stakeholders, and several such documents are used in the industry to establish a robust Pharmacovigilance system but unfortunately ambiguity is something that can never be eradicated in life sciences.
Now, coming to the logical questions: How does Oviya MedSafe manage such scenarios? How are we able to tread a clear path amidst all the confusion?
Right from Day One of Oviya MedSafe, we made it a point to jot down gray areas which seemed to be unaddressed by any of the known norms that govern industry Pharmacovigilance activities. We then periodically evaluated these gray areas against prevalent global industry working practices and from them, derived our own conservative interpretations for each such situation, which in turn were documented as ‘Oviya MedSafe Conventions‘, with specific sections for each scenario. These conventions were then added to our version-controlled list of proprietary procedural documents and our entire team has since then been trained on these conventions which are mandated to be updated whenever a business need emerges. Thanks to such conventions, we have been able to reduce bias to the highest extent possible and adopt a homogenous approach in handling such situations, much to our clients’ benefit. If you are a potential client and would like to receive more information from Oviya MedSafe in this regard, please do not hesitate to reach out to us.
Moving on, I am glad to share with you that a Letter to the Editor I wrote to the Journal of Pharmacovigilance and Drug Safety (an official publication of the Society of Pharmacovigilance, India) thanking them for naming Oviya MedSafe in the list of organizations that significantly contributed to the evolution of Pharmacovigilance in India has been published recently. That this mention of Oviya MedSafe was mainly in the context of the usefulness of Oviya MedSafe’s newsletters in enhancing awareness of Pharmacovigilance in India, makes this news worth sharing. I take this opportunity to thank the editor once again.
Before closing this newsletter edition, I am pleased to show you some snaps clicked at the 16th Annual Conference of the Indian Society for Clinical Research (ISCR) held between 23rd & 25th February 2023, in which I moderated the panel discussion ‘Innovation as a Way of Life in Pharmacovigilance‘. It was wonderful meeting some of you there.
Eager to meet you all through our March 2023 newsletter,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Phone: +91 422 2444442
Oviya MedSafe UK Ltd,
Phone: +44 20 3393 6037
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