{"id":6412,"date":"2025-07-11T12:31:35","date_gmt":"2025-07-11T12:31:35","guid":{"rendered":"https:\/\/regtechafrica.com\/healthcare\/?p=6412"},"modified":"2025-07-11T12:33:33","modified_gmt":"2025-07-11T12:33:33","slug":"indias-pharmacovigilance-momentum-takes-center-stage","status":"publish","type":"post","link":"https:\/\/regtechafrica.com\/healthcare\/indias-pharmacovigilance-momentum-takes-center-stage\/","title":{"rendered":"India\u2019s Pharmacovigilance Momentum Takes Center Stage"},"content":{"rendered":"

June 25th \u2013 26th , 2025 | Holiday Inn Mumbai International Airport<\/strong><\/p>\n

The 4th Edition Drug Safety Symposium 2025 \u2013 India Chapter<\/strong>, hosted by Eminence Business Media, once again proved to be a cornerstone event in the evolving landscape of pharmacovigilance in India. With the theme \u201cBeyond Compliance \u2013 Creating a Future-Ready, Globally Aligned PV Ecosystem\u201d<\/strong><\/em>, the two-day gathering brought together more than 150 pharmacovigilance professionals<\/strong> across the value chain, regulators, global pharma leaders, consultants, technology partners, and PV strategists.<\/p>\n

Setting the Tone: Vision, Voice & Velocity<\/h3>\n

Ms. Guneet Hayer<\/strong>, Managing Director, Eminence Group, opened the symposium with a compelling call to action: for Indian PV leaders to step out of compliance silos and begin architecting scalable, strategic systems that align with global best practices.<\/p>\n

This sentiment was reinforced by Dr. Jai Prakash<\/strong>, Senior Principal Scientific Officer and PvPI lead at the Indian Pharmacopoeia Commission, who outlined India\u2019s growing regulatory commitment and global responsibility in drug safety oversight.<\/p>\n

From a Regulatory Standpoint: Decoding India\u2019s PV Evolution<\/h3>\n

Moderated by Dr. Rahul Somani<\/strong>, a panel featuring Dr. Jai Prakash, Dr. Jamal Baig<\/strong>, and Dr. Chetanraj Bhamare<\/strong> took a deep dive into India\u2019s maturing PV regulations. The discussion emphasized the importance of regulatory foresight, system maturity, and data integrity, urging companies to evolve from \u2018checklist compliance\u2019 to strategic alignment with global harmonization goals.<\/p>\n

Voices that Matter, Conversations that Count<\/p>\n

    \n
  • A fireside chat on GCCs led by Dr. Mukesh Gori, featuring Dr. Retesh Bhumbak, spotlighted India\u2019s transformation from a delivery hub to a strategic global safety engine.<\/li>\n
  • In the MI-PV Integration Panel, Dr. Rahul Somani, Dr. Anil Pareek, Dr. Sridhar Yeshamaina and Mr. Varun Dua emphasized the necessity of breaking data silos to offer a full-circle view of patient safety.<\/li>\n
  • Dr. Shubhadeep D. Sinha tackled the nuanced monitoring of biosimilars vs. biologics, focusing on traceability, signal differentiation, and RWE integration.<\/li>\n
  • With focus on U.S, Dr. Prasad Deshmukh explored Combination Product Safety under FDA regulations and the challenge of dual data attribution.<\/li>\n
  • Dr. Anju Agarwal addressed the dynamic nature of Risk Management Plans, sharing strategies to embed RMPs and aRMMs into routine PV functions.<\/li>\n
  • Dr. Chitra Bargaje led a session on PSMF Harmonization, providing a framework to bridge local-global documentation, ownership, and versioning gaps.<\/li>\n
  • Dr. Siva Kumar Buddha mapped regulatory fragmentation in global PV practices, offering a compliance map to handle RoW variability.<\/li>\n
  • In a candid session, Dr. Nitu Sinha explored ICSR Grey Zones, including duplicate cases, causality in NIS, and follow-up strategies, offering clarity in otherwise ambiguous areas.<\/li>\n<\/ul>\n

    AI, Automation & the Real-World Roadmap: From Hype to Hands-On<\/h3>\n

    AI was not just a buzzword, it was dissected, debated, and demonstrated.<\/p>\n

      \n
    • Dr. Ashish Akar shared real-world use cases of machine learning to reduce operational burden in PV functions.<\/li>\n
    • Dr. Abhay Chimankar presented a vendor engagement framework to help PV leaders evaluate AI partners with compliance at the forefront.<\/li>\n
    • Dr. Gopal Muralidharan explored the operational impact of AI on ICSRs and literature monitoring, while also addressing system integration and data governance challenges.<\/li>\n
    • In a provocative counterpoint, Dr. Graeme Ladds highlighted the power of proven automation, cautioning against overdependence on unvalidated AI systems.<\/li>\n
    • The segment included live technology demonstration by Navitas Life Sciences, showcasing and an AI-powered literature monitoring platform, led by Dr. Pushpa Basavanapalli and Mr. Subash J.<\/li>\n
    • To close this thematic track, Souvik Chatterjee delivered a focused session on AI Validation, emphasizing the need for GxP-compliant, audit-ready frameworks to ensure AI tools meet safety-critical standards.<\/li>\n<\/ul>\n

      Workshops, Mock Audits & Compliance Tracks: Where Insight Met Action<\/h3>\n

      Dr. Rajendra Kumar Kasi\u2019s<\/strong> interactive session, Operational Excellence in Drug Safety through an Effective QMS, helped participants benchmark their current systems using a PV maturity diagnostic tool, followed by the creation of a quality scorecard tailored to global standards like GVP and FDA 21 CFR Part 11.<\/p>\n

      A standout feature was the two-part Audit Simulation by Dr. Ahmed Hegazy:<\/p>\n

        \n
      • Part 1 addressed audit expectations in RoW markets, including inspection red flags, affiliate coordination, and proactive risk management.<\/li>\n
      • Part 2 placed attendees into real-time Mock Audit scenarios, challenging them to respond to regulator queries, documentation requests, and CAPA development on the fly. The exercise concluded with a debrief and the distribution of a customizable Audit Prep Checklist.<\/em><\/li>\n<\/ul>\n

        #EminenceDigitalDetox: A Moment to Pause and Reclaim Balance<\/h3>\n

        The event witnessed a refreshing twist- #EminenceDigitalDetox<\/strong> – encouraging attendees to step away from the screen and reconnect with self and purpose.<\/p>\n

        At the Digital Detox Tree<\/strong>, delegates left thumbprint pledges in vibrant colors, a symbolic promise to take mindful breaks from digital overload. Meanwhile, the Digital Detox Booth<\/strong> allowed participants to symbolically hand over their phones, turning the spotlight inward on clarity, wellness, and inspiration born in silence.<\/p>\n

        Looking Ahead: From Dialogue to Direction<\/h3>\n

        The 4th Edition Drug Safety Symposium 2025 \u2013 India Chapter wasn\u2019t just another industry event; it was a blueprint for India\u2019s PV transformation<\/strong>. With every session, Eminence Business Media pushed the boundaries of what\u2019s possible, empowering delegates with frameworks, tools, and conversations that will shape the next era of patient safety.<\/p>\n

        As the PV community looks forward to the 5th Edition Drug Safety Symposium 2026 – Middle East Chapter<\/strong> in January 2026, one thing remains clear: patient safety doesn’t pause, and neither do we.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

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