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Conference on pharmacovigilance held in Mumbai

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It brought together drug safety experts from the lifesciences industry with an aim to discuss pharmacovigilance issues that are unique to India

Indian Pharmacovigilance Day conference was recently conducted at the Peninsula Grand Hotel, Mumbai. The one-day event was organised by Italy-based conference-producing company EasyB srl, in succession to the ‘Pharmacovigilance Day’ series of conferences conducted across Europe. It was chaired by Dr J Vijay Venkatraman, Managing Director & CEO of Oviya MedSafe, and a pharmacovigilance expert.

The ‘Pharmacovigilance Day’ conference brought together drug safety experts from the lifesciences industry: pharma companies, biotechnology firms, academic research and so on, with an aim to discuss pharmacovigilance issues that are unique to India. The topics at the event ranged from the current status of clinical trial safety, emerging postmarketing drug safety regulations, varied types of pharmacovigilance operations etc.

The conference began with an address by Dr Venkataraman, who welcomed the attendees and elaborated on the objectives of the conference. He highlighted the importance of such an event in the current Indian scenario and emphasised on the need for promoting pharmacovigilance awareness among all stakeholders.

Dr Arun Bhat, Consultant, Clinical Research & Development was the keynote speaker at the event. His session, ‘Clinical Trial Safety in India – Are we at crossroads?’, was on ensuring pharmacovigilance in clinical trials to revive the industry in India, the current challenges and the road map to overcome them.

Moin Don, CEO & Founder, PVCON Pharmacovigilance Auditing & Consulting Services was the next speaker at Indian Pharmacovigilance Day conference. He dealt with the topic, ‘A Decade of Global Pharmacovigilance Operations in India – Achievements & Learnings’.

The third session was a colloquium on the Pharmacovigilance Programme of India with insights from different stakeholders. Dr Deepa Arora, Vice President and Global Head – Pharmacovigilance & Risk Management, Lupin gave insights on the various initiatives undertaken at her organisation to promote pharmacovigilance. Dr Renuka Munshi gave an overview on the measures taken by the public hospitals to spread awareness about drug safety and improve ADR reporting, but also detailed the challenges in doing so. Gauri Kamath, Pharma and Healthcare Commentator, acted as the patients’ representative and highlighted how essential it was to educate the consumers about drug safety, reporting adverse drug reactions etc, to ensure pharmacovigilance. Dr Jamal Anwar Baig, Global Safety Country Leader, MSD Pharmaceuticals, spoke on the pharmacovigilance programme in India and recommended better cooperation between stakeholders to improve the current scenario in India. Venkataraman moderated the event.

The first post lunch session dealt with the benefits and challenges of setting up an in-house pharmcovigilance unit. Geeta Shanbagh, Deputy General Manager, Pharmacovigilance & Medico-regulatory Affairs, Ipca Laboratories, shared her experiences of setting up pharmcovigilance operations in a generic pharma company.

The next session was by Shefali Gupta, Head of Strategic Initiatives – Lifesciences, Business Process Services, Tata Consultancy Services. She spoke on, ‘Building large scale outsourced pharmacovigilance operations in India”. Dr Baig gave insights on the pharmacovigilance activities at the Indian units of global firms. He also drew parallels between the methods adopted at local Indian firms and MNCs.

Dr Arani Chatterjee, Senior Vice President, Clinical research, Biological E, in his session, explained the differences in managing vaccine safety and drug safety. Challenges in pharmacovigilance of biosimilars were detailed by Dr Dhanraj E, Pharmacovigilance Lead, BIOCON. The last session of the day was addressed by Dr Ravindra Kumar, Manager, Clinical Safety, Abbott Vascular who spoke on the practices adopted at medical device companies.

The conference ended with a vote of thanks by Venkataraman. The event was well received by all the attendees.

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