I begin this December 2017 edition of Oviya MedSafe‘s newsletter with my heartfelt wishes to you for a Happy and Prosperous New Year 2018!
Every new year kindles new hopes for our future. In this context, 2018 is, quite literally, a New Year of New Hope for Pharmacovigilance in India, thanks to the recently announced pharmacovigilance requirements for the pharmaceutical industry, effective from January 2018. While this announcement may be viewed as a local regulatory development in India, it is important to note that it impacts all Marketing Authorization Holders (MAHs) of pharmaceutical products, which term implies every drug manufacturer/importer operating in the country. Further, with Indian pharmaceutical companies being global leaders in exporting pharmaceutical products to several countries and with India being a huge pharmaceutical market for most of the foreign pharmaceutical companies, the impact of these new requirements is expected to be far-reaching in the global compliance scenario too.
Throughout the past 5 years, Oviya MedSafe has proactively been in the forefront of providing India-specific pharmacovigilance services, including focused pharmacovigilance support for Indian affiliates of foreign pharmaceutical companies. With all the accumulated expertise and our thorough understanding of the pharmacovigilance challenges faced by industry in India, we wanted to share our experience with MAHs while formally training and certifying their nominees for the role of ‘Pharmacovigilance Officer In-charge‘ (PvOI) which has been defined in the above-mentioned Guidance Document as a medical officer or a pharmacist trained in the collection and analysis of ADR (Adverse Drug Reaction) reports. This larger thought resulted in the concept of ‘One-Day Intensive Training & Certification Workshops for PvOIs‘ which we had first spoken about in our November 2017 newsletter.
Our press release about our first workshop in this series (scheduled to be conducted at Hotel Kohinoor Continental, Mumbai on Friday, 12-Jan-2018) was featured extensively in Pharmabiz and in Express Pharma, for which we are very grateful to their editorial teams. We are delighted to state that the industry’s response to our approach has been very positive and we have just a few slots remaining before we reach our target of 50 delegates. If you are an official PvOI nominee (or their nominated back-up) of an Indian MAH and wish to register for this workshop through your organization, please contact Oviya MedSafe at firstname.lastname@example.org / +918220763222. The registration fee per participant has been fixed as INR 5000 + applicable taxes only. The agenda and the registration form of the workshop can be downloaded from Oviya MedSafe’s downloads page.
On a related note, I am delighted to share that my regional report titled ‘New Pharmacovigilance Obligations for MAHs in India‘ has been published in the just-released January 2018 edition of Global Forum, a publication of the Drug Information Association (DIA). As the India Regional Editor of this magazine, I have written this opinion piece as an independent review of the above-mentioned Guidance Document. I am eager to hear your comments on this article. Please click on https://globalforum.diaglobal.org/issue/january-2018/new-pharmacovigilance-obligations-for-mahs-in-india/ to read the write-up and do share this link with anyone who may be interested.
Before concluding, I wanted to highlight another event that I am personally associated with, namely the pre-conference workshop ‘Pharmacovigilance Audits and Inspections: Preparation to effective CAPA (Corrective And Preventive Action) development and implementation‘ that is to be conducted by the Pharmacovigilance Council of the Indian Society for Clinical Research (ISCR), on the eve of the 11th Annual Conference of ISCR, at Bengaluru. This first-of-its-kind workshop will be held on Thursday 18-Jan-2018 with Ms Sophie Keddie, Dr Chitra Bargaje, Dr Jamal Anwar Baig, Ms Nidhi Vaish and Ms Indu Nambiar, along with me, as the key faculties. For more information on the workshop as well as the conference, please visit http://www.iscr.org/iscr-conference-2018/ and scroll down. It is possible to register for the pre-conference workshop alone too, in case you will not be able to attend the whole conference.
Waiting to re-connect with you through our January 2018 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,