Dear Colleagues,

Season's greetings from Oviya MedSafe

It is my pleasure to reach out to you through the August 2013 edition of Oviya MedSafe's newsletter!

I am immensely happy to announce that Oviya MedSafe has been featured in the special section "Pharmacovigilance: The way forward for India" published in the latest issue of Express Pharma, one of the leading pharmaceutical industry magazines published from India. The article showcases insights from many different personalities in the discipline of pharmacovigilance, in which I have commented on the pharmacovigilance initiatives in India, regulatory compliance trends among companies, clinicians' perspectives of reporting adverse events and suggestions for establishing and successfully running a solid pharmacovigilance system for India. It is noteworthy that a mention has been made by the author about Oviya MedSafe's growth as a pharmacovigilance consulting and outsourcing player in the industry within the brief period of its full-fledged operations since its launch in February 2013. Please visit http://pharma.financialexpress.com/sections/market-section/2507-pharmacovigilance-the-way-forward-for-india to read the complete article and share with us your feedback about it.

In continuation with the same topic of Indian Pharmacovigilance, I am glad to share with you that I have been invited as a trainer for the National Training Workshop on "Secured Medicines & Robust Pharmacovigilance - Key to Patient Safety & Health" organised by Partnership for Safe Medicines (PSM) India Initiative and Grahak Shakti in technical Collaboration with the Indian Pharmacopoeia Commission, Ghaziabad which is the National Co-ordinating Centre for the Pharmacovigilance Program of India (a Government of India initiative), on Friday, 23-Aug-2013 at Bengaluru. I have been asked to speak on "Adverse Drug Reaction (ADR) monitoring system - its status, awareness, implementation and reach", one of my favourite topics in Pharmacovigilance. For more information on the workshop, please refer to the day's agenda on PSM's website at http://www.safemedicinesindia.in/Programs_Bengaluru.pdf.

I take this opportunity to emphasize on Oviya MedSafe's featured service of the month, namely Medical Device Vigilance (Materiovigilance), which is an integral part of our service portfolio. The principal purpose of Medical Device Vigilance is to improve the protection of health and safety of patients, users of devices and others by reducing the likelihood of recurrence of adverse incidents. This is achieved by evaluation of reported incidents and, where appropriate, dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such incidents. It enables dangerous devices to be withdrawn from the market and eliminate faults in medical devices with the intention of constantly improving the quality of devices and providing patients and users with increased safety. Not only the manufacturers or their representatives but also the persons distributing devices, notified bodies, practitioners and people responsible for receiving and/or delivering the devices should all signal to the regulatory authorities when they come across untoward incidents. Incidents must be notified as quickly as possible using the quickest means possible. Incidents that have led to death or serious injury must be notified immediately.

It is relevant to note at this point that I have been requested to talk on "Global Safety Regulations for Medical Devices" at BIOYANTRA 2013 - a National Symposium on Medical Devices organized by the Department of Biomedical Engineering, SRM University, Chennai on 6th and 7th September 2013. I believe this is a significant platform for insisting upon Materiovigilance, given the expected presence of a good number of senior executives from medical device manufacturing and marketing companies at Chennai for the event. I hope to share my experiences during the symposium in our next month's newsletter.

Before signing off for the month, I would like to place on record that I had an opportunity to speak on "Phase IV Trials and Ongoing Drug Safety Management" at the workshop titled "Fundamentals of Drug Development for Pharmacology & Pharmacy Students" organized by the Department of Pharmacology, Madras Medical College in collaboration with the Indian Society for Clinical Research, at Chennai on 17-Aug-2013. I have also been invited to participate as a panelist in the panel discussion "The Road Not Taken" and talk about careers in pharmacovigilance for doctors, on 25-Aug-2013 at Tamil Nadu State CRRI CON 2013 - a state level career guidance workshop for young doctors, organized by the Coimbatore branch of the Indian Medical Association.

Looking forward to meeting you with more exciting news in September 2013,

With thanks & regards, 
Dr J Vijay Venkatraman 
MBBS, F. Diab., MBA 

Managing Director & CEO, 
Oviya MedSafe Pvt. Ltd. 
Pharmacovigilance Consulting & Services
 
2nd Floor, KTVR Gardens,
220a-3, Marudha Konar Road,
Velandipalayam, 
Coimbatore - 641 025.
Tamil Nadu, India.

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