I am overjoyed to connect with you through this June 2018 edition of Oviya MedSafe’s newsletter which bears the pride of being the 75th Issue in the monthly series I have been writing since the inception of the brand Oviya MedSafe in 2012. While this is an exciting moment for me as the Founder of the organization, I wish to humbly share the credit of the achievement of this milestone with all of you who have constantly encouraged me with your valuable feedback to my monthly mailers.
The month of June 2018 was mind-boggling, thanks to our attempt at challenging ourselves with an exercise called ‘IndUS Drug Safety‘, a one-day workshop on Indian and US FDA pharmacovigilance compliance requirements for the pharmaceutical industry. The workshop, which had my team members along with me as the trainers, was well-attended. In fact, we were surprised to see not just the young professionals we intended but quite a number of industry leaders from several globally renowned organisations too, as part of the audience. We perceived this outcome as an implicit token of trust the industry gifted to Oviya MedSafe. To our delight, the perception was ratified by the unambiguous verbal testimonials delivered by the participants at the end of the day.
During the sessions, we realized that there are differences in the ways each company approaches pharmacovigilance compliance, even in the context of well-regulated markets like the United States (US). While the norms may be clear, there may be more than one right way of performing the activities linked to them. Most of such specific directions adopted by companies were resultants of company conventions written secondary to audit or inspection findings. Of course, a one-size-fits-all approach may not work because the product portfolios as well as the circumstances under which each company was audited or inspected were widely different from each other. Moreover, the organizational structure of each company especially that of their pharmacovigilance system, plays a major role in devising such company-specific conventions. However, there was consensus among all the participants that global regulatory agencies do understand such differences and are, by and large, convinced as long as regulatory obligations are fulfilled and a proper justification (with proof of the effort invested) exists for any approach adopted by an organization.
The intense cross-learning that happened during the workshop immensely benefited the attendees per their own words, while validating the success of Oviya MedSafe’s self-challenge. To view the photographs clicked at ‘IndUS Drug Safety‘, click here.
On a related note, I wanted to share with you that my interview titled ‘Pharmacovigilance guidance document should be made part of D&C Act to ensure 100% compliance of drug industry: Expert‘ was published on 21st June 2018 in Pharmabiz, a leading pharma industry magazine in India. This interview gave me an opportunity to firmly express my independent views on the dire need to render more power to the recently-introduced Indian pharmacovigilance obligations for the pharma industry. I eagerly look forward to your comments in response to this interview and brainstorm on what more could be done in this regard.
As a matter of fact, the concepts I had highlighted in the interview influenced to a great extent the agenda of the ‘Indian Pharmacovigilance Day 2018‘ conference which I will be chairing. The conference which is to be held at Mumbai on 27-July-2018 has an India-specific session that deals with the guidance document, clinical trial safety updates and the future of the outsourced pharmacovigilance industry. A unique ‘Literature Symposium‘ has been planned to provide a complete overview of literature monitoring activities for pharmacovigilance. Another session deals with core pharmacovigilance practices, covering Signal Management, Risk Management and the role of Medical Writing. Over and above all of these, we have two distinct experience-sharing keynote addresses. I trust attending this conference would serve as a great opportunity to listen to and directly interact with distinguished speakers.
Before concluding, I wish to pass on some administrative information I received from Italy-based EasyB srl, the organisers of the ‘Indian Pharmacovigilance Day 2018‘ conference. Please note that the conference venue has been changed to Hotel Kohinoor Continental, Andheri (E), Mumbai. For online registration, the link https://www.townscript.com/e/indian-pharmacovigilance-day-2018 may be used. Registration before 20th July 2018 will be cheaper. Over and above this timeline-based benefit, discounts are available on group bookings as well. For offline registration or for any other queries, EasyB’s Indian partner agency VHEO Ventures may be contacted on +917598815311 and/or email@example.com.
Looking forward to write to you in July 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,