Writing the monthly newsletter of Oviya MedSafe is always a rejuvenating experience for me! As I compose the June 2016 edition of Oviya MedSafe’s newsletter, I heartily thank the thousands of our active readers from different parts of the world who have recognized the relevance of the contents of our newsletters to their day-to-day activities as pharmacovigilance professionals and have vividly expressed their appreciations to me on various occasions.
The hottest news of June 2016 in the global politico-economical milieu was BREXIT. While it is still not clear on what kinds of effects Brexit would have on the pharmaceutical industry at large, its impacts on pharmacovigilance obligations, procedural changes, new compliance requirements and so on have been widely speculated. I felt the LinkedIn posts by our industry colleagues Dr Deepa Arora and Dr Manoj Swaminathan worth mentioning. Some of the key speculations of concern include whether two QPPVs (one each for the EU and the UK) might be required, if EMA’s MLM service will continue to be applicable for the UK, whether a new XEVMPD will need to be compiled by MHRA, if the PSMF needs to be amended and, last but not the least on the status of the EMA Headquarters in London. The UK Pharmacovigilance Day 2016 conference which I am to Chair at London on 18th October 2016 aspires to brainstorm on this topic, among others, to bring about a direction for the way forward.
As an organization incorporated in the UK also, Oviya MedSafe is actively monitoring the developments related to Brexit. With our closely knit team of pharmacovigilance professionals located both in the EU and in the UK, coupled with our global pharmacovigilance operations centralized in India, we at Oviya MedSafe anticipate no gap in our services to our present and future clients, and are well-prepared to take up any additional workload or new assignments arising out of this paradigm shift in the EU and the UK drug regulatory scenarios. If you have any business needs in this regard, please do contact us for a discussion.
On the India front, the year so far has seen tremendous interest from the Indian drug regulators in bringing about pharmacovigilance guidelines for the industry with the involvement of other stakeholders. Meanwhile, the Pharmacovigilance Programme of India (PvPI) is widening its quantitative as well as qualitative reach. Given these developments, it is obvious that collaborative thinking is the need of the day and it is justified to cover this subject as a key conference topic.
Accordingly, the Indian Pharmacovigilance Day 2016 conference organized at Peninsula Grand Hotel in Mumbai on 29-Jul-2016 has been conceived to foster professional interaction among all stakeholders of pharmacovigilance in India. As the Chair of the conference, I am thankful to all the reputed pharmacovigilance professionals who have agreed to be part of the conference as speakers/panellists, especially Dr Y K Gupta (National Scientific Advisor, PvPI) and Dr V Kalaiselvan (Officer in-charge of PvPI) who have kindly consented to honour this conference by their presence and involvement in the session titled PvPI Colloquium. The conference, which was featured in Pharmabiz, further covers a broad spectrum of topics ranging from Clinical Safety, Pharmacovigilance Outsourcing, Experience Sharing and Special Situations in Pharmacovigilance. At this juncture, I am happy to also announce that Oviya MedSafe has decided to join the panel of sponsors of this unique conference.
Before signing off, I personally request you to consider attending the Indian Pharmacovigilance Day 2016 conference and also recommend it to your friends in the pharmacovigilance domain, with the promise of an academic feast. I hope to meet you at Mumbai.
Looking forward to connecting with you through our July 2016 newsletter,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Oviya MedSafe UK Ltd,