Oviya MedSafe – Asian Pharmacovigilance, Indian Emergence & European Compliance

Dear Well-wishers,

I am enlivened to reflect upon the invigorating developments at Oviya MedSafe over the past month, while I attempt to capture its gist for this November 2015 edition of our newsletter!

The engaging month began in an encouraging manner with my invited talk on the topic ‘South India – An Attractive and Emerging Global Pharmaceutical Hub‘ at the UK South India Business Meet 2015, which was organized by the British South India Council of Commerce (BSICC) at the UK Parliament, London on 05-Nov-2015. It was inspirational for me to share the dais at the prestigious venue, with Mr Virendra Sharma (UK Member of Parliament and Patron of BSICC who chaired the day’s proceedings) and with Dr Boora Narsaiah Goud (Member of Parliament, India who is also a renowned Laparoscopic & Gastrointestinal Surgeon), among other dignitaries. The event was felicitated by UK Members of Parliament Mr Ranil Jayawardena and Ms Angela Rayner, who also interacted with the delegates. My talk was well-received and led to discussion on South India’s untapped potential in the pharmaceutical space, both from the manufacturing and from the services perspectives. Pictures of me at the event are available at this URL. To view the entire album containing the photographs of all speakers, click here. The formal report of this event can be accessed via this link. I take this opportunity to thank BSICC for awarding me the privilege of speaking at this august gathering and also for permitting me to share these images with my network.

While I am glad about having been part of the UK South India Business Meet 2015, I regret that I missed the pride of taking part in WHO PV India 2015 – the 38th Annual Meeting of Representatives of National Pharmacovigilance Centres participating in the WHO Programme for International Drug Monitoring, which was hosted by the Indian Pharmacopoeia Commission (IPC), the National Coordination Centre of the Pharmacovigilance Programme of India (PvPI) from 4th to 6th November 2015 and inaugurated by Mr J P Nadda, Union Minister for Health & Family Welfare, Government of India. More than 150 international delegates from over 57 countries attended the meeting in which it was announced that the IPC is in the process of becoming the first WHO Collaborating Centre for Safety of Medicines and Vaccines in the South-East Asia Region. The proceedings of the meeting, which reiterate India’s commitment to pharmacovigilance, are available on this page. The commissioning of an advanced research centre at IPC in Ghaziabad (Uttar Pradesh, India) and references made to PvPI during the event may be taken as a testimony to India’s decisive approach to adopt better pharmacovigilance practices.

The second half of the month, post the Deepavali holidays, was equally intriguing from a different angle though, as the 6th Annual Pharmacovigilance Asia 2015 conference at Singapore involved me in many sessions. My speech on ‘Exploiting Social Media to Identify Potential Safety Signals and to Augment Adverse Event Data Collection‘ along with the insights of my co-speakers set the ball rolling for brainstorming on what we could expect from various regulatory agencies in terms of regulations for mining social media for adverse events in the near future and also on key technology initiatives adopted by different organizations to improve reporting of adverse events. I was proud to mention that PvPI has already launched a mobile application for reporting suspected adverse drug reactions during this panel discussion and that the PvPI has agreed to collaborate with the Indian Medical Association to sensitize Indian doctors on the significance of reporting adverse events to the PvPI while sharing my opinion in another session about the recent developments in Indian pharmacovigilance. The post-conference workshop titled ‘Case Narrative Writing for Reporting Adverse Events‘ which I conducted along with my colleagues was quite impactful, as we could perceive from the audience at the end of the session. At the end of the conference, it was evident that Asia Pacific as a region is quickly catching up with the regulated markets in terms of pharmacovigilance regulations, as most of the deliberation coming from the reputed speakers in this region was on advanced subjects like Risk Management and Signal Management.

Coming back to India, I am happy to let you all know that I have been honoured by an invitation to speak on the topic ‘What you need to have in Pharmacovigilance in order to market your products in the EU‘ at a seminar titled ‘Drug Development in Europe – Market Entry into Europe through Clinical Research‘ organized by Berlin-based Lumis International GmbH along with the Indo German Chamber of Commerce, for biopharmaceutical companies intending to conduct clinical research in Germany. At this event organized at Taj Vivanta MG Road in Bengaluru on 03-Dec-2015, I will share with the audience Oviya MedSafe’s experiences in dealing with European Pharmacovigilance Requirements. If you are a pharmaceutical or biopharmaceutical manufacturer and are interested in attending this seminar, please click here to register. Registration is mandatory but free of cost. I hope to meet some of you at Bengaluru on 03-Dec-2015.

Thanking you for the patient reading and signing off now until we connect in end December 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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