Dear Colleagues,

I am immensely happy to connect with you through this September 2014 edition of Oviya MedSafe’s newsletter, which will not only update you about our organization but also provide you with useful insights on the recent advancements made in the domain of pharmacovigilance across the world, especially in India.

As you know, Oviya MedSafe (in association with UK-based Assured Information Systems) organized a free webinar titled ‘Assuring Cost-Effective Global Pharmacovigilance Compliance’ for pharmaceutical companies on 10-Sep-2014, which session included a complimentary demonstration of Assured Information Systems’ human pharmacovigilance hosted software database PV247. The patronage for the webinar & demo session far exceeded our expectations and helped us realize that what we already offer at the moment is exactly the pharmacovigilance package that pharmaceutical companies would dream of, for the future: a comprehensive, reliable, economical, E2B & 21 CFR Part 11 compliant, user-friendly and global solution.

It is my duty to thank leading pharmaceutical industry magazines Express Pharma and Pharmabiz for featuring the news about the event and our partnership for PV247 respectively. With our inboxes being filled with appreciations and requests for more information, we have begun to think that we should run such sessions periodically on a regular basis, for the benefit of those who missed our first event. I take this opportunity to thank all the attendees of the webinar & demo and look forward to your comments on it.

In general, pharmacovigilance is now more in the news than it was ever before, not only in Europe in the background of the MHRA’s WEB-RADR project to screen social media for drug safety information or the implementation of the EMA guideline on pharmacovigilance inspections, but also in countries like India.

The Pharmacovigilance Programme of India recently opened its doors to consumer reporting of drug adverse events, evolved for itself a guidance document in line with the WHO-NRA recommendation, and signed up with the National AIDS Control Organization to monitor the safety of the anti-retroviral drugs used, which are major breakthroughs for any country’s national pharmacovigilance programme.

At the same time, the mainstream media too seem to have come up with their best efforts to report incidents connected with suspected adverse drug reactions, follow-up stories on why other patients did not develop those adverse drug reactions, genuine educational attempts made by agencies such as the Maharashtra State Pharmacy Council to check drug-drug interactions by aiding pharmacists with software, ‘banned drugs’ being available in India (visibly inspired by a much better researched and more complete article by Ms Gauri Kamath titled ‘Why India still sells medicines banned elsewhere in the world’) and so on.

All the above developments indicate that pharmacovigilance regulations specific for India (especially for marketed products) need to be drafted and enforced at the earliest in order for pharmaceutical companies operating in India to ensure compliance with the regulatory requirements in India which would also help them remain compliant with the regulations in the other markets in which they are present. This is probably the time for all the stakeholders of Indian pharmacovigilance to come together under a common forum and resolve these larger issues amicably. 

Before I conclude, I am glad to share with you the news about two conferences in which I will be speaking. The conferences organized by the OMICS group are co-located and will be conducted between 27-Oct-2014 and 29-Oct-2014 at Hyderabad International Convention Centre, Hyderabad, India.

I have been requested to deliver one of the keynote addresses at the 3rd International Conference and Exhibition on Pharmacovigilance & Cinical Trials 2014 on the topic Hosted Pharmacovigilance Software Databases - The Emerging Solution. I will also talk on the topic Pharmacovigilance of Biosimilars - Challenges & Possible Solutions at the 3rd International Conference and Exhibition on Biowaivers, Biologics and Biosimilars 2014. I look forward to reaching out to you with more details soon.

Looking forward to meeting you all in October 2014 with news of further interest,

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

Managing Director & CEO, 
Oviya MedSafe 
Pharmacovigilance Consulting & Drug Safety Services
Coimbatore, India & London, UK

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