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Oviya MedSafe - Balancing Subject Matter Expertise & Technology in Pharmacovigilance

Dear Well Wishers,

I am pleased to reach out to you through this May 2019 edition of Oviya MedSafe‘s newsletter which intends to elucidate Oviya MedSafe’s pragmatic approach in balancing subject matter expertise & technology in pharmacovigilance, a strategy that has kept us lean and therefore successful ever since we adopted it in 2012.

Oviya MedSafe is well-qualified to deliberate on this topic as we have not only advised, sourced, customized and deployed appropriate technology to support the pharmacovigilance functional systems we created for ourselves as well as for our clients; but as we have also been contracted for providing functional consultancy services to organizations that work exclusively on the technical side of pharmacovigilance. While the first part of the preceding sentence was explained in our April 2017 newsletter, I would like to share my thoughts on the second part in a little more detailed manner in this edition.

While technology has greatly accelerated the ability of any subject to be advanced further, pharmacovigilance is no exception. Starting from a simple spreadsheet to a modern full-fledged pharmacovigilance software database, technology has taken pharmacovigilance experts through an exciting journey which progressively reduced the time consumed by non-core tasks thereby saving it for activities involving higher functional analysis. Today, the buzzwords Robotic Process Automation (RPA), Artificial Intelligence (AI), Cognitive Computing, etc, stand for the emergence of technology-aided pharmacovigilance of the highest order that the previous generation of pharmacovigilance experts could only feel envious about. While technology does resolve several logistical issues pertaining to pharmacovigilance, it is important to recognize that even the most revolutionary technological tool will require functional inputs at several levels, along with provisions for appropriate checks and balances. In other words, facilitating the building of futuristic yet dependable technological products for pharmacovigilance and ensuring that they are fit for purpose could well be specialized pharmacovigilance consulting activities by themselves. Oviya MedSafe takes pride in having realized this fact several years ago and developed holistic pharmacovigilance subject matter expertise which now proves to be a skill set that many pharmacovigilance technology companies yearn for, regardless of whether they work for large pharmaceutical companies or for their small & medium-sized counterparts.

On taking a deeper dive into the topic, it is clear that technology does not stop with pharmacovigilance software databases alone. Mobile applications for reporting adverse events, applications which harvest potential drug safety data from social media, proprietary workflow applications designed by some organizations to standardize certain parts of their pharmacovigilance processes, intuitive off-the-shelf software applications meant for helping medical information staff with the right questions to be asked when callers report adverse events, tailored tools for reconciling safety data, portals for securely transmitting safety data between organizations, pharmacovigilance document management systems, and electronic training modules with performance metrics are some instances in which technology is closely involved in pharmacovigilance beyond safety databases. Obviously, all of these and many more of such offerings need ongoing functional advice in order for them to cope up with the ever-changing regulatory scenario. This is particularly difficult for technology companies which may have little or limited exposure to the functional side of pharmacovigilance. Thanks to our rich pharmacovigilance domain experience of working with a variety of pharmaceutical clients across the globe for the past seven years and our astute understanding of the challenges faced by pharmacovigilance toolmakers, Oviya MedSafe is now being increasingly recognized as a strategic partner by pharmacovigilance-focused technology companies that wish to develop cutting edge pharmacovigilance products.

Although many would argue that regulation is the primary driver for so many pharmacovigilance activities to be performed in the industry, conscientious pharmacovigilance professionals would understand that such regulation exists in the first place in order to secure the interests of the consumer who takes a drug trusting that it would benefit them. While any drug cannot be expected to render only benefits to all consumers all the time, the proper performance of applicable pharmacovigilance activities would ensure that a consumer’s risk is reduced to as less as possible while leveraging the maximum therapeutic benefit for the consumer. I have been invited to elaborate on this concept at the ‘Continuing Medical Education on Pharmacovigilance: Clinical Implications‘ organized by Vydehi Institute of Medical Sciences & Research Centre, Bengaluru in collaboration with the Pharmacovigilance Programme of India (PvPI), on 19th July 2019 at the college. I am eager to deliver my address on the topic “The Role of Pharmaceutical Industry in bringing about Translational Pharmacovigilance” and look forward to interact with the students and young professionals in Bengaluru.

Last but not the least; I wish to speak a little about the annual Indian Pharmacovigilance Day conference which I will chair for the 4th consecutive time this year. The 2019 edition of the conference which is to be held at Hotel Kohinoor Continental, Mumbai on Friday, 26th July 2019 boasts of a galaxy of seasoned speakers who will deliberate upon matters of contemporary significance in the context of the various forms in which pharmacovigilance exists in India. I hear from the organizers that the agenda has already attracted a good number of delegate registrations and that they expect to reach a record number of participants before the last minute fee becomes applicable on the registration charges after 21st July 2019. To register yourselves to be part of this phenomenal knowledge-sharing gathering, please click on https://www.townscript.com/e/indian-pharmacovigilance-day-2019.

Waiting to meet you through our June 2019 newsletter,

With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)

Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Coimbatore, India
Phone: +91-422-2444442

Director,
Oviya MedSafe UK Ltd,
London, UK
Phone: +44-8452-733839

Web: www.oviyamedsafe.com
Mail: info@oviyamedsafe.com
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