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Oviya MedSafe - Facilitating US FDA Pharmacovigilance Compliance of ANDA Holders

Dear Well-wishers,

While your words of acclaim continue to pour into my inbox to compliment Oviya MedSafe’s 6th anniversary which we celebrated last month, I am delighted to connect with you through this April 2018 edition of Oviya MedSafe’s newsletter!

Before getting into the subject, it may be relevant for me to highlight the fact that the European Union General Data Protection Regulation (EU GDPR) is to be enforced from 25-May-2018. The GDPR not only applies to organizations located within the EU but will also apply to organizations located outside of the EU if they offer goods or services to, or monitor the behaviour of, EU data subjects. It applies to all companies processing and holding the personal data of data subjects residing in the European Union, regardless of the company’s location. Being a compliance-conscious organization, we at Oviya MedSafe are very keen to ensure that our periodic communications are well within the law.

Hence, Oviya MedSafe herewith makes an earnest request to all EU-based readers of our monthly newsletters to kindly respond to this e-mail in order to let us know that you are willing to receive such mailers from us beyond 25-May-2018 too, failing which we will not be able to share Oviya MedSafe’s monthly pharmacovigilance insights with you. Of course, we understand that this regulation impacts only our EU-based readers and those of our readers based in non-EU locations will continue to receive our communications until you choose to unsubscribe by following the instructions appended in our mailers. In case you have any concerns about this approach which we have adopted, please do not hesitate to let us know.

Marketing their products in the United States (US) of America is one of the key aspirations any growing pharmaceutical company would have. This aspiration is primarily based on the fact that leading drug manufacturers based in countries like India make most of their profits from the US market. Hence, it is not surprising that the pharmaceutical industry is more inclined to spend for (or rather invest in) pharmacovigilance for US FDA compliance than for any other region. I had had the opportunity to cover such perspectives in greater detail in the invited article ‘Pharmacovigilance as a Value Addition for the Pharma Industry‘ which was published in November 2016 by Express Pharma, a leading Indian pharma industry magazine.

Oviya MedSafe has been adept in providing end-to-end pharmacovigilance services for holders of US FDA approved Abbreviated New Drug Applications (ANDAs). The pharmacovigilance requirements mandated by US FDA for ANDA-holders and our innovative methodology in setting up and running a ready-to-use cost-effective pharmacovigilance system especially for micro, small & medium-sized companies were detailed in Oviya MedSafe’s November 2016 newsletter. While I was reflecting upon these points, I realized that it may be of great support to emerging pharmaceutical companies (current or future ANDA-holders) if we organized a workshop on US FDA pharmacovigilance compliance in the likes of the ‘One-Day Intensive Training & Certification Workshops for Pharmacovigilance Officers In-charge (PvOIs)‘ which we first conducted in Mumbai earlier this year to elucidate the new pharmacovigilance obligations for Marketing Authorization Holders (MAHs) in India.

Given the fact that most of the current/future US ANDA-holders based in India would also fulfil the criteria for MAHs (which term implies ‘a manufacturer or an importer of a pharmaceutical product who has a valid manufacturing or import license in India‘, according to the Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products), we came to believe that it may be prudent to combine the US FDA pharmacovigilance compliance component with the next edition of our training & certification workshops for PvOIs.

Consequently, I am glad to announce that Oviya MedSafe will conduct ‘IndUS Drug Safety‘, a one-day workshop in which both the Indian as well as the US pharmacovigilance obligations for the pharma industry will be dealt with in detail. The event shall be held in Mumbai on Friday 29th June 2018. The registration fee per participant has been fixed as INR 6000 + applicable taxes only, in order to encourage as many micro, small and medium-sized companies as possible to get their personnel responsible for pharmacovigilance trained and certified by Oviya MedSafe. For registration and/or more information on this workshop exclusively meant for pharma industry delegates only, please contact Oviya MedSafe at info@oviyamedsafe.com or +91-82207-63222.

On a different note, I am glad to share that the ‘Indian Pharmacovigilance Day 2018‘ conference which I am to Chair for the third consecutive time (as detailed in our March 2018 newsletter) has garnered a good amount of attention and already has expressions of interest for the registrations. This event shall be organized by Italy-based conference-producing company EasyB srl, at Mumbai on Friday 27th July 2018. Please keep watching the conference website for updates in the forthcoming weeks.

Before signing off, I wanted to acknowledge and thank the Organization of Pharmaceutical Producers of India (OPPI) for having invited me to represent Oviya MedSafe as a company that provides pharmacovigilance services for Indian compliance, at their ‘OPPI Medical Forum 2018‘ that was held at Mumbai on 3rd May 2018. I had the opportunity to present on the topic and also the honour to share the stage with Dr V G Somani, Joint Drugs Controller (India), in the panel discussion that ensued. An added privilege I had during the same trip to Mumbai was to have been invited by Dr Urmila Thatte, Professor & Head of the Department of Clinical Pharmacology, King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College, Mumbai, to speak on ‘Life with Pharmacovigilance‘. The post-lecture interaction I had with the staff & students in the department was very interesting and resulted in quite a lot of mutual learning, which I attribute with thanks to Pharmacovigilance that chose me!

Looking forward to meeting you in our May 2018 newsletter,

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

Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Coimbatore, India
Phone: +91-422-2444442

Director,
Oviya MedSafe UK Ltd,
London, UK
Phone: +44-8452-733839

Web: www.oviyamedsafe.com
Mail: info@oviyamedsafe.com
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