Dear Well-wishers,

On the World Patient Safety Day 2020, I am delighted to post this August 2020 edition (the 95th in the series since April 2012) of Oviya MedSafe‘s newsletter! It is indeed a pleasure that I am able to pass on to you my thoughts for the completed month on this special day.

According to the World Health Organization, the objectives of World Patient Safety Day are to increase public awareness and engagement, enhance global understanding, and spur global solidarity and action to promote patient safety. While these objectives are shared goals for all the stakeholders involved, I wish to take this opportunity to highlight the responsibilities of the pharmaceutical industry in this context.

Although the terms Patient Safety and Pharmacovigilance are not necessarily synonymous, having a proper pharmacovigilance system in place is the bare minimum that a pharmaceutical company should be doing if it is inclined to honour its commitment to Patient Safety. It is obvious that many companies set up pharmacovigilance departments but such efforts are more often the results of external pressure rather than of their own interest. External pressure not only denotes regulatory mandates but also the business obligations of a company towards its partners. Moreover, not all of such pharmacovigilance departments are as active as they are supposed to be. While ‘compliance-driven pharmacovigilance’ is and should always be the primary focus of the pharmaceutical industry, the true purpose of ‘pharmacovigilance for patient safety’ is not fulfilled unless proactive pharmacovigilance is practised.

At the mention of the term ‘proactive pharmacovigilance’, I have often come across the scenario where it was misinterpreted as ‘soliciting safety data’. As pharmacovigilance professionals, all of us know that unsolicited safety data and solicited safety data considerably differ in the weightage attached to them. However, we cannot expect healthcare professionals and/or consumers to report safety data unless they are made aware of what, how, when, why and to whom they should report. While it is mainly the duty of governments to create such awareness, a conscientious pharmaceutical company is expected to extend voluntary support in this direction as the spirit behind the compliance obligation attached to it is that patient safety is of paramount importance. Such positive measures form the foundation for the culture of proactive pharmacovigilance to be built within a pharmaceutical company, with its safety data collection system being the elevation. This is a non-negotiable need even if a company has outsourced the rest of its pharmacovigilance activities. In fact, imparting a sense of proactive pharmacovigilance to a hitherto pharmacovigilance-naive pharmaceutical company is one of the most underrated fundamental duties a pragmatic pharmacovigilance service provider should undertake as soon as they have been contracted.

In this context, I am glad to recollect that Oviya MedSafe has grown to be recognized as a champion for the cause of proactive pharmacovigilance time and again. What is more heartening is that all our clients have often expressed that the customized pharmacovigilance systems we created for each of them have not only fulfilled their compliance needs but have actually enlightened them by demystifying the much feared discipline of pharmacovigilance. Of course, we have come a long way before experiencing this sense of achievement and not before doing our math of balancing the industry’s best practices with the acceptance levels of every client at a micro level. Naturally, this turned out to be a successful Unique Selling Proposition (USP) of ours over the past 8 years and I am sure it will remain so for the future too, as evidenced by our ever-growing list of new customers as well as repetitive business from our current ones.

Moving on from the principal topic, I am pleased to share with all of you the article ‘Challenges and Dilemmas of Operationalizing COVID-19 Clinical Research in India‘. It was my pride to facilitate this original content from India on this coveted subject authored by Dr Pooja Sharma and Anirban Roy Chowdhury for the August 2020 edition of Global Forum, a DIA publication, in my honorary role as its Regional Editor for the country. Please click here to read the write-up. As always, feedback is welcomed not only by the editorial board but also by the learned authors.

Last but not the least: Let me take the pleasure of inviting you to register for the (virtual) Autumn Conference of the Indian Society for Clinical Research (ISCR) on ‘Clinical Research Landscape – Post 2020‘ organized by the South Chapter of the society and scheduled for 9th and 10th October 2020. Along with Dr Ramesh Jagannathan, I am in-charge for the Pharmacovigilance & Real World Evidence track. The PDF flyer and the intriguing agenda featuring speakers from various countries are available on the respective embedded links. I hope we can get to e-meet during this event 😊

Eager to re-connect with you through our September 2020 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: +44-8452-733839

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