Dear Colleagues,

With the flowers of Pharmacovigilance blooming throughout the world, I wish to share their fragrance with you by handing this June 2015 bouquet of Oviya MedSafe’s newsletter!

This universal season of enhanced awareness of Drug Safety began with the launch of the VigiAccess website (which I had detailed in Oviya MedSafe’s May 2015 newsletter) and warrants celebration with a song for sure! And, can there be a song more appropriate than ‘Take & Tell’ conceptualized by the Uppsala Monitoring Centre (UMC), to celebrate the science of Pharmacovigilance? I personally feel that, as evangelists of Patient Safety, all of us need to promote this ‘Take & Tell’ initiative and use it to motivate healthcare professionals and consumers to report suspected Adverse Drug Reactions (ADRs) to the relevant authorities.

Despite the facts that pharmacovigilance is a global concept and that harmonisation of drug safety regulations is much talked about across the globe, the need for customized regulations for specific regions does exist with its own reasons. Nevertheless, many countries or groups of countries have adopted their regional guidelines from the Good Pharmacovigilance Practices (GVP), a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU), with varying levels of adaptations.

The Middle East Asian and the African countries are of particular mention in this regard, as they have not only legislated the guidelines but have also implemented them quite some time ago. These guidelines cover all the available GVP modules with some amendments for national purposes. These guidelines could significantly influence pharmacovigilance practice in the concerned regions and are expected to augment the adverse event reporting rates while enabling detection of signals from these parts of the world.

We at Oviya MedSafe have had the privilege of working with clients from these regions over the past three years and completely understand the challenges faced by marketing authorization holders in complying with the new pharmacovigilance obligations. Accordingly, Oviya MedSafe has risen to the occasion by rendering cost-effective pharmacovigilance services with 21 CFR Part 11 & E2B compliant drug safety software database support. I am proud to mention that Oviya MedSafe’s offerings for these regions include assessment of the marketing authorisation holders’ pharmacovigilance obligations and execution of all the applicable drug safety tasks such as adverse event reporting (including electronic submissions where required), literature monitoring, aggregate reporting, risk management planning, signal detection and all other pertinent services.

Speaking of regional pharmacovigilance compliance from an Indian perspective, an Office Order dated 18-May-2015 (effective from 01-Jun-2015) issued by the Indian Pharmacopoeia Commission (IPC), the National Coordination Centre for the Pharmacovigilance Programme of India (PvPI) under the Ministry of Health & Family Welfare, Government of India states that pharmaceutical companies need to submit ADRs due to their respective pharmaceutical products in XML-E2B format to PvPI to hasten the process of uploading Individual Case Safety Reports (ICSRs) to VigiFlow, a web- based database of UMC. This measure is expected to enhance the process of assessment of ADRs reported in India and facilitate the detection of signals from Indian data.

While pharmaceutical companies in India do collect suspected ADR reports from healthcare professionals through their marketing teams, only a few of them have pharmacovigilance departments and drug safety software databases to generate ADR reports in XML-E2B format needed to comply with the Office Order. It is here that Oviya MedSafe emerges as the most reliable and comprehensive yet simple and economic solution for pharmaceutical companies to adhere to the Office Order. With Oviya MedSafe already being a pioneer in promoting India-specific pharmacovigilance services such as authoring Periodic Safety Update Reports (PSURs) for submission to the Central Drugs Standard Control Organization (CDSCO) on behalf of our clients, the addition of XML-E2B ADR reporting support complements our portfolio of services in this vertical.

I take this opportunity to thank pharmaceutical industry magazines PharmaAsia (Singapore), PharmiWeb (UK) and Express Pharma (India), for featuring the news of the introduction of our support services for pharmaceutical companies to report ADRs in XML-E2B format to PvPI. I also thank Pharmabiz for interviewing me and mentioning my comments in their news report on the Office Order.

Further, I am pleased to inform you about my involvement in two forthcoming pharmacovigilance conferences, both of which are scheduled to be held at London, namely, the 4th International Conference and Exhibition on Pharmacovigilance & Clinical Trials to be conducted by OMICS International and the UK Pharmacovigilance Day 2015 conference to be organized by EasyB, as an Organising Committee Member and as a Chair, respectively.

OMICS International’s event in August 2015 will see Oviya MedSafe represented by reputed Pharmacovigilance Consultant and Oviya MedSafe’s UK Business Advisor Mr Alistair J Coates who will speak on the topic ‘European Pharmacovigilance under EudraVigilance and the eXtended Eudravigilance Medicinal Products Dictionary (XEVMPD) environment within it‘. I take the privilege of inviting you to register for the conference which is certain to serve the audience with a scientific feast in global drug safety.

Last but not the least, I am delighted to state that I will be in the UK in October 2015 to chair EasyB’s event and conduct the day’s proceedings along with my good friend Dr Sumit Munjal, Medical Director Lead, Global Pharmacovigilance at Takeda Pharmaceuticals, UK. I will also participate in the 10th Annual Conference of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK and hope to get the opportunity to meet drug safety colleagues from all over the European Union during these conferences.

Signing off for now, to meet you with more engaging news in July 2015,

With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA., FPIPA (UK)

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

India Office: +91-422-2444442
UK Office: +44-8452-733839

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