With immense fervour, I compile this August 2016 edition of Oviya MedSafe’s newsletter which aims to elucidate a key differentiating feature of ours and invite you to consider participating in two important pharmacovigilance events in which we are formally involved – one to be held in New Delhi and the other in London.
Pharmacovigilance (PV) operations, especially in the outsourced scenario and more particularly when it involved offshoring, have almost always been performed in fragments irrespective of their scale. On some occasions, end-to-end processing activities were outsourced but still cross-functional capability development within the team was not a mainstream strategy. This approach was justified until recently by the lack of experience of the newly groomed PV professionals in the evolving regions wherefrom the services were delivered and by the lead time needed by large global pharmaceutical companies to make and implement such drastic decisions, although cost-effectiveness and scalability were compelling reasons for the paradigm shift to occur.
With the concept of PV outsourcing/offshoring having attained reasonable maturity as a business vertical in countries to which PV work has been offshored, we see that we have huge numbers of PV professionals with commendable specialist-level expertise in some specified sets of PV activities but not in all of them. It is common understanding that several sub-activities have to be sewn together to form the complete spectrum of PV as a global industry practice, with excellence in qualitative and quantitative efficiency in operations being the fine but firm interconnecting thread. While many traditional organizations providing outsourced services have the capabilities to carry out all PV activities at the organizational level, they have been finding it challenging to develop holistic PV talent at the level of each individual in their team. This can primarily be attributed to the fact that fulfilling the business goals of managing tight deadlines and heavy workloads to the satisfaction of the existing clients ranks much higher in the priority list.
One could argue that concentrating on comprehensive capability development at the individual level may not be important beyond the purpose of rendering job satisfaction to PV staff. But, the need of such holistic PV thinkers is being felt, especially when the client is a small pharmaceutical company who wishes to outsource PV activities not to save cost or to enhance operational efficiency but to bring in the PV expertise they lack. Evidently, such clients do not need an expensive PV service provider that can take care of their PV liabilities only by deploying a big team because of the simple reason that their scale of operations cannot afford their charges. Hence, comprehensivising the erstwhile model of compartmentalised PV in the outsourced setting appears to be the future business need, with small and mid-sized pharmaceutical companies needing such support being many more in number than the top-rankers in the ‘Big Pharma’ which were the ones that required, created and are generally comfortable with the compartmentalisation in their outsourced PV operations, justifiably so due to their business volumes across the globe.
Recent news from Europe such as the improvement in drug safety monitoring evidenced since the enactment of the new PV legislation and the release of the Designated Medical Events List by the EMA (European Medicines Agency) emphasize the fact that performing good PV indeed alters the benefit-risk ratio of the medicinal product in favour of the consumer. While this obvious truth has been proven on multiple occasions in the western world, the ‘Emerging Markets’ or ‘RoW Countries’ are not far behind in learning from the global past, and their competent authorities have begun to increasingly adopt PV as a regulatory norm for the pharmaceutical industry. Given this scenario, holistic PV professionals capable of creating PV systems and meticulously carrying out various PV activities in compliance with them are required in order to fulfil the drug safety obligations of the pharmaceutical industry, especially in these regions and more specifically for generic drugmakers that have limited budgets for PV. Acclaimed and individually well-experienced PV experts are available, although not in huge numbers, to create systems but a Comprehensive Boutique Consultancy is what is required to establish and run a PV system in an organization that hitherto did not have one, and not just a service provider accustomed to the conventional model of Compartmentalised PV or an individual expert who could perform only an advisory role.
At this juncture, I am proud to state that Oviya MedSafe is pioneering the evolution from today’s world of compartmentalisation to tomorrow’s need of comprehensiveness in PV, without compromising on any of the principal tenets of a PV business enterprise which includes regulatory compliance, cost-effectiveness, scalability and deployment of appropriate technology, among others. It is not surprising for me because Oviya MedSafe was conceived that way. Although we have never hesitated to function as a conventional PV service-provider to clients who have strong drug safety systems, we always felt that our all-encompassing support has been most needed by drug manufacturers and/or marketing authorization holders with absent, nascent or inadequate PV systems. Our aspiration of being identified by the industry as the “Single Window” to go to for all their PV requirements has been achieved, thanks to the smart work of Team Oviya MedSafe over the past four and a half years. We believe that this professional philosophy makes Oviya MedSafe unique and will continue to inspire all our strategies for the future.
Moving on to the first of the two events I hinted about, I am delighted to announce that Oviya MedSafe will be a sponsor of the 3rd National PV Symposium of the Indian Society for Clinical Research (ISCR), which is to be held on Saturday, 24-Sep-2016 at Holiday Inn New Delhi International Airport, New Delhi. The theme of the symposium is “Evolving a Pharmacovigilant Environment in India – Collaborations, Opportunities & Challenges” and it has renowned speakers representing all stakeholders of PV in India. Incidentally, I have been asked to speak at the symposium on the topic “PV as a value addition to the pharmaceutical industry in contemporary Indian scenario“, which I eagerly look forward to. I wish to take this opportunity to invite you to register online to attend the symposium by visiting the URL www.iscrpvsymposium.com which also has the agenda and the facility to receive online payments for ensuring quick completion of registration.
Last but not the least; I am pleased to mention that I will be travelling to London to Chair the UK Pharmacovigilance Day 2016 conference, which has shaped up quite well with a mix of conventional and innovative PV topics for deliberation. I will write more about this conference in our next newsletter but wish to request you to start registering to attend as the places are filling up fast. Needless to say, I will be available and keen to meet UK colleagues for business discussions during my forthcoming short stay in the UK in October 2016.
Thanking you for the patient reading and awaiting to connect with you through our September 2016 newsletter,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Oviya MedSafe UK Ltd,
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