I begin writing this July 2018 edition of Oviya MedSafe‘s newsletter with limitless exuberance, thanks to the grand success of the third consecutive annual Indian Pharmacovigilance Day conference that was organized under my chairpersonship at Mumbai on 27th July 2018. Organized by Italy-based conference producer LS Academy (a business unit of EasyB srl), the conference had renowned pharmacovigilance professionals sharing their experiential wisdom with the enthusiastic audience. Please refer to the news reports published by Express Pharma and Pharmabiz for more details of the day’s proceedings. To view/download the official photographs of the conference, kindly click here.
While reflecting upon two major aspects the conference was applauded for, namely the wide variety of topics covered in a single day and the integrated approach adopted towards the discipline of pharmacovigilance, I realized that I had probably subconsciously built the agenda as a corollary to how Oviya MedSafe got structured over the past six years as a ‘go-to’ organization for pharmacovigilance. It is unsurprising given the fact that Oviya MedSafe’s clientele has invariably been diverse in parameters such as company size, kind of products, scientific temper, type of licenses, marketing authorization status, country of origin, regulatory norms to be complied with, and so on, which has, in turn, played a significant role in the metamorphosis of Oviya MedSafe to what it is today – an exemplification of a versatile organization that provides comprehensive pharmacovigilance services to the pharmaceutical industry. In support of this seemingly tall claim, this newsletter edition intends to showcase the heterogeneity of Oviya MedSafe’s clients and indicate how each category of clients had different needs as follows:
• Multinational Pharmaceutical Innovators: Oviya MedSafe has a rich history of working with five of the top twenty multinational pharmaceutical innovators. Writing subject narratives for Clinical Study Reports, providing end-to-end support for local affiliates, processing Individual Case Safety Reports (ICSRs), delivering corporate training to pharmacovigilance as well as non-pharmacovigilance staff, and performing local literature monitoring are some of the activities we have carried out on behalf of clients who fall under this category.
• Global Generic Pharmaceutical Companies: Clients that fall under this category are not innovators but are those which sell their generic products in several countries. Oviya MedSafe has such clients from many parts of the world and has garnered extensive experience in setting up end-to-end pharmacovigilance activities including drug safety software database deployment for such clients, for both regulated and semi-regulated markets. Most of the Global Literature Monitoring, Aggregate Reporting and the Risk Management parts of Oviya MedSafe’s repertoire of services have been delivered to this category of clients. Further, Oviya MedSafe has prepared Pharmacovigilance System Master File (PSMF) and, in the past, Detailed Description of Pharmacovigilance System (DDPS) too, for clients in this category to submit in different countries with varying pharmacovigilance requirements.
• Drug Manufacturers with Marketing Partners: In countries like India, the holder of a manufacturing license or an import license is responsible for pharmacovigilance compliance. Although the Pharmacovigilance Guidance Document for Marketing Authorization Holders (MAHs) of Pharmaceutical Products labels the above-mentioned manufacturers/importers as MAHs, it is a misnomer in many cases, as there are several companies which only manufacture finished products under their own licenses. Their products are procured vide business agreements by other pharmaceutical companies which in turn engage in marketing the products. In such scenarios, the client’s understanding of pharmacovigilance would usually be suboptimal and the budgets meagre. Oviya MedSafe has been recognized by such clients as a knowledgeable, trustworthy and cost-effective pharmacovigilance partner.
• Drug Distributors in Different Countries: Oviya MedSafe has a good deal of experience in addressing the pre-approval/post-approval pharmacovigilance consultancy needs of drug distributors (sometimes known as Local MAHs) in countries where the manufacturers or the main MAHs did not have direct presence. Interaction with Qualified Persons for Pharmacovigilance (or QPPV equivalents known by different names in emerging markets) who would take care of the local liaison was a critical part of the activity. Establishing pharmacovigilance quality assurance systems and performing gap analyses of such systems were significant specialized services rendered to clients who fell under this category. Providing pharmacovigilance training to such QPPV equivalents also formed a key part of the business engagements with such clients. Onsite training sessions in foreign locations have also been conducted by Oviya MedSafe in more than one occasion.
• Producers of Biologics/Vaccines: Oviya MedSafe has been having its share of carrying out pharmacovigilance activities for niche products like biologics (including biosimilars) and vaccines, with regulatory reporting facilitated for many countries.
• Technology Firms: With technology having proven itself as an enabler of continuous and incremental advancements in pharmacovigilance, Oviya MedSafe has began supporting this novel category of clients with functional consulting from a futuristic perspective.
What has made Oviya MedSafe triumphant in all engagements we have had with any client of ours is our strict adherence to the applicable written procedures. In fact, I am proud to mention that we have used our own Standard Operating Procedures (SOPs), Work Instructions (WIs) and Guides for most of our clients. Thanks to our robust and proactive Quality Assurance department, Oviya MedSafe has always been inspection-ready and has cleared external audits with ease. In short, the broad acceptance of Oviya MedSafe’s ready-to-use pharmacovigilance system by our clients is a result of our meticulous teamwork overarched by our unflinching commitment to attaining the peak of domain excellence.
While we have indeed come a long way as a boutique pharmacovigilance consultancy enriching our long list of clients all along by epitomizing our multi-pronged approach, I believe it is time to consider shifting our goalpost. I trust that not only Oviya MedSafe but also our future clients will benefit a lot if we express our expertise at a much larger scale by growing our team. To pursue this self-set growth target, Oviya MedSafe has started contemplating on whether venture capital investments could be accepted, which is a topic I may write in detail sometime in the future. I thank you for your patient reading and wish to hear your feedback on this letter.
Looking forward to re-connecting with you in August 2018,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Oviya MedSafe UK Ltd,