Dear Well-wishers,

I am pleased to meet you through this March 2023 edition of Oviya MedSafe‘s newsletter (the 124th in the series since April 2012) in which I intend to outline some practical challenges faced by fast-growing multinational pharma/biotech/healthcare companies when they begin to constitute an integrated global Pharmacovigilance system aimed at attaining total regulatory compliance involving all their markets and covering all their products. Obviously, I also am zealous of telling you how Oviya MedSafe as their global Pharmacovigilance Service Provider helped them overcome such challenges effectively.

If we trace the natural history of a typical generic company, we commonly note that Pharmacovigilance used to be considered an upfront investment only when the company planned to place its marketed products for sale in developed countries. Later, some developing countries brought about minimal Pharmacovigilance requirements but the implementation was not that stringent. Underdeveloped countries were yet to make their presence felt on the global Pharmacovigilance map. However, with time, the continuous upward mobility of drug regulations across the globe has now made Pharmacovigilance relevant in almost all markets today albeit with varying intensities. As a result, multiple Pharmacovigilance systems existing within the same organization has become unavoidable.

To start with, the prototype for the integrated global Pharmacovigilance system must be determined. Unlike a Pharmacovigilance-naive organization in which it is actually easier to build a Pharmacovigilance system from scratch, an organization that already has several affiliates in different geographies with varying levels of regulatory expectations pertaining to Pharmacovigilance will find it difficult to identify the primary system into which all the secondary systems need to merge in order to form a single comprehensive system that retains the most advantageous characteristics of all the systems. The ideal candidate for the prototype would be the most demanding as well as the most inclusive system, upon which the specific compliance needs of individual affiliates could be built. Considering that each affiliate would have been complying with the local regulations in their own way and to the extent of their choice until then, the very mention of integration may often cause apprehension in the minds of the key personnel. But, it is to be remembered that the purpose of integration is progress and does not mean loss of freedom. In fact, it couples freedom with accountability, and ensures productivity.

After identifying the prototype, the organization has to set up a task force to study the best practices of each Pharmacovigilance system which include thorough review of the written procedures, Pharmacovigilance agreements with partners, measures in place for collection of safety data from all sources, documentation on Pharmacovigilance activities carried out in-house versus activities outsourced to service providers, stored source documents, audit & inspection reports, status of CAPAs, Pharmacovigilance software databases used, any automation efforts taken that could impact Patient Safety, all communication with regulatory authorities, important internal documents like Minutes of Meetings, escalation mechanisms and so on. The organization should identify a Global Head for Pharmacovigilance who shall lead the task force which would consist of the Pharmacovigilance Heads of all the affiliates. In case the organization already has presence in markets with highly evolved regulations such as the EU or the UK, the concerned QPPVs shall also play key roles in the task force. The Corporate Quality Assurance department should also have representation in the task force. Essentially, this means that the outcome should be the establishment of a global Pharmacovigilance hierarchy with the mandate of making the integrated organization much more compliant than its individual constituents were ever before. Unfortunately, it is not easy for all organizations to achieve this harmony by themselves and that is where Oviya MedSafe is here to help smiley 

Oviya MedSafe, as a premier boutique consultancy firm in Pharmacovigilance, has rich experience not only in creating Pharmacovigilance systems for our smaller clients but also in bridging the gaps in the Pharmacovigilance frameworks of our larger clients. Oviya MedSafe possesses a success formula for constituting the task force as stated above and driving it on behalf of our clients to ensure that its purpose is fulfilled, a feat that has been perfected by our practice over a decade’s time. We understand that each client is unique and that drives us to engage in deep discussions with all stakeholders of Pharmacovigilance at our client’s and come out with a customized plan to streamline the client’s global Pharmacovigilance system. As an interested but independent third party, we then proceed to execute the plan on behalf of our client, never once missing the larger picture. We take care to maintain the arm’s length distance so that we remain fair to all stakeholders in our client organization which also helps the case as we are least likely to get influenced by any particular stakeholder unit. Finally, we play a significant role in convincing the C-suite of our clients on the transformation that needs to happen in their Pharmacovigilance function without which there would be no hope for betterment. Thanks to our reputation for integrity and efficiency, we have almost always been asked by such clients to continue as their sole or principal Pharmacovigilance Service Provider, thereby validating the triumph of our well-structured hybrid model of Pharmacovigilance offerings.

To conclude, let me take the help of the legendary Lebanese-American writer, poet and visual artist Kahlil Gibran. As he says at the end of his famous poem titled ‘Fear‘, the verses “The river needs to take the risk of entering the ocean because only then will fear disappear; because that’s where the river will know it’s not about disappearing into the ocean, but of becoming the ocean“, appear to be so relevant to a fast-growing multinational pharma/biotech/healthcare company that aspires to integrate and harmonize its Pharmacovigilance systems under a single umbrella. Needless to say, every such ocean that we see in the industry today was once a river that was afraid of disappearing into the ocean! At Oviya MedSafe, we take nothing but immense pride in allaying these fears of tomorrow’s oceans.

Looking forward to connect with you soon through our April 2023 newsletter,

With thanks & regards,
Dr J Vijay Venkatraman

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

Oviya MedSafe UK Ltd,
London, UK
Phone: +44 20 3393 6037

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