I am pleased to reach out to you through this May 2021 edition of Oviya MedSafe‘s newsletter (the 104th in the series since April 2012) in which I intend to share with you some of my perspectives on what the cornerstone for good pharmacovigilance in any organization is. Yes! You guessed it right: I am talking about the existence, adequacy, relevance, implementability and evaluability of written procedures.
Written procedures are of many forms such as standard operating procedures, work instructions, guides, manuals, policies, conventions and so on. These are pretty standard terms with unique definitions available in public domain and are used across many industries in the context of their quality management systems. While written procedures are considered “good to have” in many industries, pharmacovigilance is one of those sensitive fields where these are absolutely “need to have“. In several pharmacovigilance inspections across the world, findings related to written procedures have arguably been the most common as well as the most critical ones. This unfortunate state of affairs, especially in many small and mid-size pharma/biotech companies, appears to be an outcome of their tendency to undermine the significance of having solid written procedures in place. It is analogous to a movie producer asking his director to begin shooting without a script in hand at all, or having written just the plot summary with not much effort invested in finalizing the setting of the story, sketching the characters, planning the schedule and taking opinions from interested third parties.
We all know how important a meticulously written script is to a movie that exhibits quite a lot of detail. Not just the main knot but in fact every key element in a movie needs to be conceived and visualized in prior. The conversations between characters, leitmotifs, body languages of the artistes, backdrops in each scene, and everything else would sound logical only if they are within the scope of the script. While having a good script does not guarantee a good movie by itself, not having a script at all is definitely a journey towards failure, even if the director is seasoned and is confident of going extempore on the sets. Pharmacovigilance is quite similar to a movie that warrants tremendous attention to detail and no amount of professional seniority can compensate for the lack of proper written procedures. In other words, it is the strength of the system that matters in pharmacovigilance rather than that of any particular individual. Akin to how directors have intense brainstorming sessions with their scriptwriters to make the movie better than themselves, the role of strong individuals working in pharmacovigilance is actually to collaboratively develop a pharmacovigilance system that is stronger than all of them put together. In short, just as the script enables direction in cinema, written procedures direct pharmacovigilance in an organization. Further, properly performed pharmacovigilance ensures regulatory compliance just like how a well-directed movie achieves its target of engaging the audience.
Since 2012, Oviya MedSafe has written many such tight scripts for other directors (consultancy services in pharmacovigilance), directed scripts of others to their delight (outsourced pharmacovigilance activities according to our clients’ written procedures), and been the successful scriptwriter & director for our producers (clients) who totally entrusted their movies (hybrid model of consultancy & outsourced services in pharmacovigilance) to us. Occasionally, we have also been consulted for third party opinions (performing gap analysis in pharmacovigilance) by other scriptwriters and directors for their own movies at various stages of production, as pharmacovigilance is a movie that always has to enthral the viewers. We have been phenomenally successful in all these roles thanks to our team members who never get tired of facing new pharmacovigilance challenges on behalf of our clients and instead always enjoy the process of identifying solutions for their problems.
As an organization that loves pharmacovigilance, Oviya MedSafe is heartened to state that more than 50 clients (pharma, biotech, vaccine, CRO & technology companies) have benefited from our pharmacovigilance offerings and we warmly invite you too to experience our expertise.
The month of May has always been special since the time I became part of the clinical research discipline, thanks to the International Clinical Trials Day which is observed on 20th May every year. On this day in 2020, I wrote a short LinkedIn article “Happy Birthday, Clinical Trials! Thank you, COVID-19!” as a response to my friend who demanded a COVID-19 vaccine. Within this one year, Science has proven to everyone what it is capable of, by bringing out quite a few vaccines already and assuring that many more are in the pipeline. Many clinical trials have been conducted to prove the safety and efficacy of various COVID-19 treatment options as well. These speak volumes of the hard work done by hundreds of scientists during all stages of research & development that deserve to be celebrated on par with our frontline COVID warriors. On this occasion in 2021, I had the privilege of emphasizing this point to the entire physician fraternity across India in my honorary capacity as the Chairman of the Indian Medical Association (IMA) Standing Committee for Pharmacovigilance, by organizing a talk by the renowned Dr Nilima Kshirsagar on “The Role of Clinical Trials in Assuring the Safety of Medicines“. The 90-minute programme was well-attended and applauded by all the participants for the useful content. If you wish to watch the recorded webinar, please click on this link.
I am excited to inform you that we are all set to conduct the next session on behalf of the IMA Headquarters Standing Committee for Pharmacovigilance on a very attractive topic “Medico Legal Aspects of Adverse Drug Reactions” by Dr Subhrojyoti Bhowmick. The webinar is scheduled for Tuesday 22nd June 2021 from 5 pm to 6:30 pm IST. The Zoom link to join this webinar is https://bit.ly/3gv8bTA. Please do add this event to your calendar if you wish to be part of this novel and intriguing initiative from the IMA.
Looking forward to connecting with you through our June 2021 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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