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Oviya MedSafe to conduct day-long workshop on Indian & US FDA pharmacovigilance compliance on June 29

Our Bureau, Mumbai
Saturday, June 2, 2018, 08:00 Hrs  [IST]

Oviya MedSafe, a six-year-old global pharmacovigilance consulting and drug safety services providing organization based in India and the UK, will organise “IndUS Drug Safety”, a day-long workshop on Indian and US FDA pharmacovigilance compliance requirements for the pharma industry, on June 29, 2018 at Hotel Kohinoor Continental, Mumbai.

Speaking to the media, Dr J Vijay Venkatraman, managing director and CEO of Oviya MedSafe said, “As soon as the Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products became effective in January 2018, Oviya MedSafe organized a one-day intensive training & certification workshop for 'Pharmacovigilance Officer In-charge’ (PvOI) candidates, at Mumbai. The term 'Marketing Authorization Holder' (MAH) refers to a manufacturer or an importer of drugs who has a valid manufacturing or import license in India. The idea for this successful initiative emerged from Oviya MedSafe's recognition of the dire need for training PvOI candidates across the country, since the guidance document further emphasized the requirement spelt out by GSR 287(E) dated March 8, 2016 for one qualified and trained personnel to be authorized by the MAH as the PvOI.”

During the workshop which was enthusiastically attended by PvOIs from several Indian MAHs, we realized that Oviya MedSafe was expected to conduct similar workshops on pharmacovigilance compliance requirements for developed countries, especially those of the US.

This expectation was not surprising, as any growing pharma company would have a strong urge to own approved Abbreviated New Drug Applications (ANDAs) in the US. This aspiration is primarily based on the fact that leading Indian drug manufacturers make most of their profits from the US market. Moreover, holding ANDAs in the US would augment the valuation of the company. Hence, it is obvious that the pharma industry is interested in understanding the US pharmacovigilance requirements, fulfilling which is inevitable for their FDA compliance. With Oviya MedSafe being adept in providing end-to-end pharmacovigilance services for US ANDA-holders by deploying our innovative methodology in setting up and running a ready-to-use cost-effective pharmacovigilance system especially devised for micro, small & medium-sized companies, it is natural that the pharma industry chose to hear from us on this subject.

Given the fact that most of the current/future US ANDA-holders based in India would also fall under the category of 'MAHs' according to the guidance document, we decided that it would be prudent to combine the US FDA pharmacovigilance compliance component with the next edition of our training and certification workshops for PvOIs which we had assured to continue conducting. And thus, the concept of “IndUS Drug Safety” was born, said Dr Venkatraman.

The workshop will be open to employees/management representatives of pharma companies only, with preference to staff from pharmacovigilance/regulatory affairs/marketing/medical affairs departments. Certificates would be issued to the attending delegates.


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