The workshop will be open to pharma companies, with preference to representatives from Pharmacovigilance / Regulatory Affairs / Marketing / Medical Affairs departments only.
Oviya MedSafe has announced ‘IndUS Drug Safety’ – a One Day Workshop on Indian and US FDA pharmacovigilance compliance for the pharma industry. The event will be held in Mumbai on June 29, 2018. Oviya MedSafe, a 6-year-old global pharmacovigilance consulting and drug safety services-providing organisation based in India and the UK.
Dr J Vijay Venkatraman, MD & CEO of Oviya MedSafe says, “As soon as the pharmacovigilance guidance document for Marketing Authorization Holders (MAH) of pharma products became effective in January 2018, Oviya MedSafe organised a one-day intensive training and certification workshop for Pharmacovigilance Officer In-charge (PvOI) candidates, at Mumbai. The term MAH refers to a manufacturer or an importer of drugs who has a valid manufacturing or import license in India. The idea for this initiative emerged from Oviya MedSafe’s recognition of the dire need for training PvOI candidates across the country, since the guidance document further emphasised the requirement spelt out by GSR 287(E) dated 08-Mar-2016 for one qualified and trained personnel to be authorised by the MAH as the PvOI. During the workshop which was enthusiastically attended by PvOIs from several Indian MAHs, we realised that Oviya MedSafe was expected to conduct similar workshops on pharmacovigilance compliance requirements for developed countries, especially those of the United States of America (US).”
He further says, “This expectation was not unsurprising, 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 & certification workshops for PvOIs which we had assured to continue conducting. And thus, the concept of ‘IndUS Drug Safety’ was born.”
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.