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Oviya MedSafe for PvOIs of Indian MAHs - Pharmacovigilance Training & Certification Workshops

Dear Well-wishers,

I am proud to present this November 2017 edition of Oviya MedSafe’s newsletter, which aims at introducing to you one of our key initiatives for the year 2018 – a series of one-day intensive training & certification workshops exclusively for Pharmacovigilance Officers In-charge (PvOIs) of Marketing Authorization Holders (MAHs) of pharmaceutical products in India!

As explained in the September 2017 edition of our newsletter, the recently released Pharmacovigilance Guidance Document for MAHs of Pharmaceutical Products is set to be effective from January 2018. According to this document, the term MAH refers to a manufacturer or an importer of a pharmaceutical product who has a valid manufacturing or import license in India. One of the most salient features laid out by this document is the requirement for a named PvOI, which aspect is elucidated in Section 1.4.1 of Module 1, as below in verbatim:

“In compliance with Schedule-Y of Drugs and Cosmetics Act, 1940 and Rules, 1945, one qualified and trained personnel should be authorized by the company management as PvOI with responsibilities for dealing Pharmacovigilance (PV) activities at MAH’s organization. This PvOI should be a medical officer or a pharmacist trained in the collection and analysis of ADR (Adverse Drug Reaction) reports. PvOI shall be responsible for the following:

– Development of training modules and organizing training for staff of PV department;

– Identification of PV activities and framing of Standard Operating Procedures (SOPs), revision of SOPs;

– Establishment & maintenance of the Quality Management System (QMS) of PV department;

– The PvOI should reside in India and respond to queries of regulatory authorities whenever required.

The information relating to the PvOI provided in the Pharmacovigilance System Master File (PvMF) shall include:

• Contact details (Name, address, phone, e-mail);

• Summary, curriculum vitae with the key information on the role of the PvOI;

• A description of the responsibilities guaranteeing that the PvOI has sufficient authority over the PV system in order to promote, maintain and improve compliance; and

• Details of duty-in-charge to work in the absence of PvOI.”

With Oviya MedSafe having been active in the Indian pharmacovigilance compliance space since 2013, we are already aware that the pharmacovigilance expertise levels in Indian MAHs vary right from being regulatorily self-sufficient (typically in companies that market their products in regulated markets) to literally non-existent (often in companies that hold manufacturing licenses but seldom market their products even domestically). However, the above-detailed requirements for a PvOI, among all other pharmacovigilance obligations detailed in this document, will be applicable across all organizations that qualify to be MAHs as defined above. While Oviya MedSafe has an enviable track record of working with several clients to help them comply with their global pharmacovigilance obligations (including Indian) as an outsourced partner, we also realize that we should take ownership for building the capacities of our clients’ staff, especially the PvOI nominees so that they could perform their roles in line with the expectations of them.

While thinking on these lines, I began wondering how Oviya MedSafe could extrapolate this capacity-building activity to the wider industry and ensure that as many Indian MAHs as possible could be benefited. It is then that the idea of conducting one-day intensive pharmacovigilance training & certification workshops exclusively for PvOIs emerged. I further believe that the certification associated with this activity will validate the training in the collection & analysis of ADR reports which is mandatory for PvOIs according to this document.

Given this background, Oviya MedSafe is happy to announce that the first such one-day intensive training & certification workshop for PvOIs of MAHs will be conducted at Hotel Kohinoor Continental, Mumbai on Friday 12-Jan-2018. The workshop will be open only to official PvOI nominees of Indian MAHs. The registration fee per participant has been fixed as INR 5000 + applicable taxes only, in order to encourage as many micro, small and medium-sized MAHs as possible to get their PvOIs trained and certified.

For registration and/or more information, please contact Oviya MedSafe at +918220763222 and info@oviyamedsafe.com. We plan to conduct this workshop at other locations in India in quick succession to this one.

Looking forward to meet you through our December 2017 newsletter soon,

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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