The two-day conference discussed the latest trends and developments in pharmacovigilance, drug safety and medical affairs and the impact of innovations like artificial intelligence, machine learning, automation and real-world evidence on driving better safety outcomes
DIA India recently organised the 7th Pharmacovigilance Conference in Mumbai on the theme “Transforming Clinical Safety and Pharmacovigilance”. The two-day conference discussed and explored the latest trends and developments in the space of pharmacovigilance, drug safety and medical affairs and the impact of innovations like artificial intelligence, machine learning, automation and real-world evidence on driving better safety outcomes. The programme created under the expert guidance of Moin Don, President and CEO, PVCON Consulting as programme chair, Dr Krishna Bahadursingh, Fellow of the Faculty of Pharmaceutical Medicine (UK) as co-chair and a stellar programme committee of senior industry executives from the Indian healthcare fraternity, was successful in fostering international exchange of actionable regulatory, medical and commercial insights to advance drug safety and pharmacovigilance.
With seven individual sessions, over 15 presentations and two panel discussions, the 7th Pharmacovigilance conference convened 31 distinguished national and international subject matter experts from regulatory, industry,and academia and engaged global decisionmakers and influencers with more than 200 professionals participating from the pharmaceutical, biotechnology services and academic communities globally.
Day one of the conference witnessed the keynote session by Dr YK Gupta, Former Dean, AIIMS, New Delhi, wherein the Indian clinical trial safety scenario and the changing regulatory landscape for drug safety in India were discussed. This session was followed by presentations focussing on global regulatory developments in pharmacovigilance including ICH E2B (R3), FAERS, Eudravigilance and the impact of Brexit was also discussed in a session led by Dr J Vijay Venkatraman, MD and CEO, Oviya Medsafe .
Another session kicked off with a presentation on ‘Reimagining Case’ processing with Artificial Intelligence by Soumyanarayan Srinivasan, MD, Accenture Lifesciences and Sumanta Ghosh, Pharmacovigilance Practice Lead, discussing the increasing automation with disruptive technology and its positive impact on quality and patient safety. The following panel session moderated by Moin Don and Anju Agarwal, Head, Pharmacovigilance, Advanz Pharma, led to several interesting questions from the audience on the result of digital transformation and its impact on jobs in the future. The industry stalwarts’ part of this panel opined on the changing landscape with job role evolution instead of head count reduction and the transition from safety data management to safety data science which will pave the way for next generation pharmacovigilance professionals.
In course of this discussion, the impact of digitisation on audit requirements were discussed. In coming times as more and more of safety management will be automated, it is pertinent to stay in line with changing regulatory requirements in line with that same and being audit ready. Some insightful questions were brought up including best practices, implementing learning from other industries and the outlook from different regulators.
One of the sessions witnessed industry stalwarts discussing emerging trends in pharmacovigilance and upcoming business models in safety. This session included presentations discussing the role of various drug safety professionals in changing times and through consolidations, mergers and acquisitions. Dr Ute Heffner, EU QPPV, Glenmark Arzneimittel GmbH talked about the management of a global PV system and the alignment required across regions to disseminate safety information globally. The day ended with the last session focusing on the upcoming business models in pharmacovigilance and the emerging hybrid outsourcing trends.
Day two kicked off with Dr Dhananjay Bakhle, Executive Vice President, Medical Research, Lupin delivering his address on striking the right balance between safety and survival in cancer immunotherapy and the session touched upon the complexities of safety management in oncology trials and overcoming the challenges.
This was followed by aengaging session on the role of medical affairs- 2020 and beyond, chaired by Dr Aamir Shaikh, Founder, Assansa. The session delved deep into the evolving role of medical affairs today and the competencies to be developed for the next phase. Dr Vinod Mattoo spoke on how the role of medical affairs is combining with pharmacovigilance locally and globally. This was followed by Dr Krishna Bahadursingh discussing the safety issues in immune-oncology and approaches to the same in light of the evolving medical and safety practices.
A session named ‘Evolving Systems and Approaches to Effective Pharmacovigilance- Emerging Markets session’, had Rawya Al Kredly, Head, Pharmacovigilance, Julphar Pharma UAE and Manoj Swaminathan, Head, Global Pharmacovigilance, Piramal Enterprises, discuss emerging PV practices and guidelines in the middle east and emerging markets including China, Korea and ASEAN region.
A panel discussion chaired by Dr Krishna Bahadursingh, along with senior executives from Indian biopharma and services organisations highlighted the impact of digitisation on audit requirements..
The last session of the event chaired by Dr Retesh Kumar, Global Safety Practice Lead, Cognizant Technology Solutions on enhancing patient safety through enhanced vigilance practices saw Dr Dnyaneshwar Sanap, Associate Director, Risk Management, Boehringer Ingelheim, Germany, discussing the planning, execution and monitoring of effectiveness of risk minimisation activities by sharing some real-life cases. Following Dr Sanap, Dr Dhanaraj E, Global PV Lead, Biocon shed light on the risk and safety aspects of biosimilars and lastly, presentation of the day by Kanchan Sakhare from Cognizant Technology Solutions discussed process re-engineering to enhance quality.