As I sit down to chronicle the October 2018 edition of Oviya MedSafe‘s newsletter, I am unable to help exclaiming about the variety of Pharmacovigilance angles the month subjected me to!
On one side was KRUPACON 2018, a composite conference conducted by Krupanidhi Group of Institutions at Bengaluru, in which I had a chance to share my insights with Pharmacy and Management students separately. The inaugural function of KRUPACON 2018 bestowed upon me the honour of sharing the dais with Dr B Suresh, President of the Pharmacy Council of India (PCI), along with several other dignitaries from India and overseas. I spoke to Pharmacy students on the topic ‘Monitoring Product Safety Beyond Clinical Trials: Industry Practices‘. I trust my talk gave them a fair overview of what they could expect to do if they get to join the industry as Pharmacovigilance professionals in the future. In the co-located Management conference, I opined on the topic ‘Operational Disruptions in the Knowledge Industry‘. As an entrepreneur, I felt glad to have influenced the thought process of young Management professionals, especially with reference to the Knowledge Services segment under which Oviya MedSafe’s Pharmacovigilance offerings may be broadly categorized. Photographs of my participation in KRUPACON 2018 are available for viewing/download from this link.
On the other side was my participation as a panelist at the ‘One Day Training Workshop on Good Clinical Practice (GCP) & Local Regulations for Clinical Trials‘ organized by Indian Society for Clinical Research (ISCR) & Coimbatore Respiratory Society (CRS) at Coimbatore, in which I was able to apprise a group of Clinical Investigators and other Clinical Research Professionals regarding the recent developments in the regulatory requirements pertaining to Pharmacovigilance in India. The workshop also gave me an opportunity to learn from the other Clinical Research experts who also spoke at the event. The fact that I was invited to speak at such an intense Knowledge Sharing event which was conducted at Coimbatore, the place where both Oviya MedSafe and I were born, rendered a special feeling to me. To view/download some pictures which were clicked at the workshop, please click here.
While re-visiting these experiences, I feel that Pharmacovigilance, with its various forms, is relevant to several stakeholders in different ways. It also means to say that standardization of Pharmacovigilance (as an activity) needs to be done separately and uniquely for each stakeholder depending on the nature, depth, need, timelines and extent of their vested interest in the domain. For example, standardizing a Pharmacovigilance process that is carried out by the industry for regulatory compliance is dissimilar from doing so for a process pertaining to voluntary reporting of adverse events by a healthcare professional. To put it differently, the standards of assessment should not be the same because we cannot assess apples against the standards set for oranges. I think it would be appropriate to elucidate this point further as the word ‘standards’ means different things for different people. Although it is generally used synonymously with ‘quality’, I personally feel ‘standards’ is the pedestal on which ‘quality’ is constructed. In other words, standards refer to the efforts and quality refers to the results. The higher standards we maintain, the higher quality we get. Not surprisingly, the Collins English Dictionary defines ‘standards’ not only as “criteria; a level of quality used to judge or compare something else” but also as “principles of propriety, honesty, and integrity” which vindicates my postulate.
At this moment, I find it pertinent to mention that we at Oviya MedSafe, on our own, cultivated Pharmacovigilance standards for every activity that we have been involved in, right from our inception in 2012. As an organization providing global Pharmacovigilance consulting and Drug Safety services, Oviya MedSafe has always believed that the long-term success of any business entity depends on how it standardizes itself against the known standards in the industry. As the Founder, I have seen Oviya MedSafe growing not only by doing so but by also creating standards in certain aspects of our portfolio of services which were tailored for clients who had little prior understanding of Pharmacovigilance. The fact that we had internally resolved to treat every client of ours (irrespective of the maturity of their Pharmacovigilance understanding) equally, ensured that we set the highest quality target, namely 100%, more so for the clients who did not request for it. To achieve this quality, we standardized every process in the organization, both intrinsic and extrinsic, ranging right from the core departments of Pharmacovigilance and Quality Assurance to the entire set of support functions such as Business Development, Administration, Information Technology, Human Resources and so on. Thanks to our Quality Management System which has highly evolved over the past six and a half years, Oviya MedSafe possesses the ways and means to attain this stage.
I would like to attract your attention to the February 2018 edition of Oviya MedSafe’s newsletter in which I had written in detail about how important Integrity is to Oviya MedSafe and of our July 2018 edition which explained how the robustness of our Quality Assurance function ensured Oviya MedSafe’s growth as a versatile organization supporting the Pharmacovigilance requirements of the global industry. I believe re-reading these newsletter editions from a cause-effect angle would further facilitate your comprehension and hopeful acceptance of this confident substantiation. I wish to thank you for your patient reading and welcome your feedback on this note.
Waiting to re-connect with you through our November 2018 edition,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Oviya MedSafe UK Ltd,