The event was a part of the series of the “Pharmacovigilance Day” conferences organised globally by Life Science Academy
The Indian Pharmacovigilance Day 2019 conference was recently held in Mumbai, as a part of the series of the ‘Pharmacovigilance Day’ conferences organised in several parts of the world since 2014 and India since 2016, by Life Science Academy, a business unit of Italy-based conference-producing company EasyB srl.
Dr J Vijay Venkatraman, MD and CEO, Oviya MedSafe was nominated as the Chair consecutively for the 4th Indian Pharmacovigilance Day following the success of the three annual Indian Pharmacovigilance Day conferences held in Mumbai (in 2016 & 2018) and Hyderabad (in 2017) under his chairmanship.
The conference started with a brief welcome address by Enrico Pedroni, Managing Director, EasyB srl, Italy, followed by Dr Venkatraman’s address as the Chair to the delegates about the nature and purpose of the conference. The first session of the conference started to sail with the topic ‘Significance of Pharmacovigilance in Regulatory Decision-Making’ by the first keynote speaker Dr Darshan Bhatt, Senior Consultant, Pharmacovigilance, who shared his experiential wisdom and his perspectives on the subject with the audience. This session was followed by the second keynote speaker Dr Sanish Davis, Country Head & Senior Medical Director, Covance, who enthralled the audience with his address on ‘Metamorphosis of Clinical Trial Safety in India – Triumph of Collaboration’.
The next session was ‘Practical Pharmacovigilance in India’ which had two pharmacovigilance heads from the industry offering complimentary as well as contrasting viewpoints on a single topic, followed by a third speaker providing a cross-sectional analysis on another. The audience was enlightened with the knowledge shared by Geeta Shanbhag, Senior General Manager – Pharmacovigilance and Medico-regulatory Affairs, Ipca Laboratories and Indu Nambiar, Head Pharmacovigilance, Boehringer Ingelheim, on the topic ‘Customising a global pharmacovigilance system for Indian compliance’.
While Shanbhag spoke in the context of an India-headquartered multinational generic company, Nambiar delved upon the subject in the context of an Indian affiliate of a foreign multinational innovator company. Following intense interactions the audience had with the two speakers, Dr RK Sanghavi, Sr Consulting Clinician Advisor – Positive Health, Expert, Healthcare Industry, was requested to present on ‘Bringing HCPs, MAHs and Regulatory Authorities together for Pharmacovigilance: Challenges in India & possible solutions’. The solutions proposed by Dr Sanghavi for the challenges he enlisted in his presentation resulted in a healthy debate on the practicality of and rationale behind the same.
The third session of the day titled ‘Global Pharmacovigilance Perspectives’ began with Dr Abhijit Surwade, Global Pharmacovigilance Physician, Colgate-Palmolive, giving an overview on ‘Regulatory Requirements and Safety Assessment of Consumer Health Products’. He was followed by Dr Shraddha Bhange, Associate Medical Director, EVERSANA, who presented on the topic ‘Roles of WHO, National Regulatory Agencies & Industry in ensuring Vaccine Safety across the globe’. Both these speeches generated numerous questions from the audience which were well-answered by the speakers, resulting in a participative experience for the audience on highly specialised sub-functions of pharmacovigilance.
Durga Mane, Associate Director – Delivery Excellence, Cognizant Technology Solutions, the third speaker of the session, gave a lucid talk on a subject that is very much pertinent to the daily activities of global pharmacovigilance professionals, namely ‘Significance of Internal Audits in Outsourced Global Pharmacovigilance Operations’.
The last session of the day had the theme ‘Transforming for Tomorrow’. The session began with the well-presented topic ‘Technology as an enabler of effective Safety Signal Surveillance’ by Dr Neelesh Joshi, Head – Drug Safety Practice, Tata Consultancy Services, who justified the title with several examples. The final talk of the day titled ‘The Future of Pharmacovigilance: A Peek into the Crystal Ball’ was delivered Aamir Shaikh, Founder, Assansa. The day ended with closing comments and vote of thanks by Dr J Vijay Venkatraman and the delegates left with the fulfilment of getting a bird’s eye view of several facets of Pharmacovigilance in India, as envisioned by the organising team.
The conference was sponsored by Dialog Solutions and Oviya MedSafe.