India’s Pharmacovigilance Momentum Takes Center Stage
Event Report: Highlights from the 4th Edition Drug Safety Symposium 2025 – India Chapter
June 25th – 26th, 2025 | Holiday Inn Mumbai International Airport
The 4th Edition Drug Safety Symposium 2025 – India Chapter, hosted by Eminence Business Media, once again proved to be a cornerstone event in the evolving landscape of pharmacovigilance in India. With the theme “Beyond Compliance – Creating a Future-Ready, Globally Aligned PV Ecosystem”,... moreIndia’s Pharmacovigilance Momentum Takes Center Stage
Event Report: Highlights from the 4th Edition Drug Safety Symposium 2025 – India Chapter
June 25th – 26th, 2025 | Holiday Inn Mumbai International Airport
The 4th Edition Drug Safety Symposium 2025 – India Chapter, hosted by Eminence Business Media, once again proved to be a cornerstone event in the evolving landscape of pharmacovigilance in India. With the theme “Beyond Compliance – Creating a Future-Ready, Globally Aligned PV Ecosystem”, the two-day gathering brought together more than 150 pharmacovigilance professionals across the value chain, regulators, global pharma leaders, consultants, technology partners, and PV strategists.
Setting the Tone: Vision, Voice & Velocity
Ms. Guneet Hayer, 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.
This sentiment was reinforced by Dr. Jai Prakash, Senior Principal Scientific Officer and PvPI lead at the Indian Pharmacopoeia Commission, who outlined India’s growing regulatory commitment and global responsibility in drug safety oversight.
From a Regulatory Standpoint: Decoding India’s PV Evolution
Moderated by Dr. Rahul Somani, a panel featuring Dr. Jai Prakash, Dr. Jamal Baig, and Dr. Chetanraj Bhamare took a deep dive into India’s maturing PV regulations. The discussion emphasized the importance of regulatory foresight, system maturity, and data integrity, urging companies to evolve from ‘checklist compliance’ to strategic alignment with global harmonization goals.
Voices that Matter, Conversations that Count
• A fireside chat on GCCs led by Dr. Mukesh Gori, featuring Dr. Retesh Bhumbak, spotlighted India’s transformation from a delivery hub to a strategic global safety engine.
• 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.
• Dr. Shubhadeep D. Sinha tackled the nuanced monitoring of biosimilars vs. biologics, focusing on traceability, signal differentiation, and RWE integration.
• With focus on U.S, Dr. Prasad Deshmukh explored Combination Product Safety under FDA regulations and the challenge of dual data attribution.
• Dr. Anju Agarwal addressed the dynamic nature of Risk Management Plans, sharing strategies to embed RMPs and aRMMs into routine PV functions.
• Dr. Chitra Bargaje led a session on PSMF Harmonization, providing a framework to bridge local-global documentation, ownership, and versioning gaps.
• Dr. Siva Kumar Buddha mapped regulatory fragmentation in global PV practices, offering a compliance map to handle RoW variability.
• 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.
AI, Automation & the Real-World Roadmap: From Hype to Hands-On
AI was not just a buzzword, it was dissected, debated, and demonstrated.
• Dr. Ashish Akar shared real-world use cases of machine learning to reduce operational burden in PV functions.
• Dr. Abhay Chimankar presented a vendor engagement framework to help PV leaders evaluate AI partners with compliance at the forefront.
• Dr. Gopal Muralidharan explored the operational impact of AI on ICSRs and literature monitoring, while also addressing system integration and data governance challenges.
• In a provocative counterpoint, Dr. Graeme Ladds highlighted the power of proven automation, cautioning against overdependence on unvalidated AI systems.
• 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.
• 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.
Workshops, Mock Audits & Compliance Tracks: Where Insight Met Action
Dr. Rajendra Kumar Kasi’s 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.
A standout feature was the two-part Audit Simulation by Dr. Ahmed Hegazy:
• Part 1 addressed audit expectations in RoW markets, including inspection red flags, affiliate coordination, and proactive risk management.
• 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. #EminenceDigitalDetox: A Moment to Pause and Reclaim Balance
The event witnessed a refreshing twist- #EminenceDigitalDetox - encouraging attendees to step away from the screen and reconnect with self and purpose.
At the Digital Detox Tree, delegates left thumbprint pledges in vibrant colors, a symbolic promise to take mindful breaks from digital overload. Meanwhile, the Digital Detox Booth allowed participants to symbolically hand over their phones, turning the spotlight inward on clarity, wellness, and inspiration born in silence.
Looking Ahead: From Dialogue to Direction
The 4th Edition Drug Safety Symposium 2025 – India Chapter wasn’t just another industry event; it was a blueprint for India’s PV transformation. With every session, Eminence Business Media pushed the boundaries of what’s possible, empowering delegates with frameworks, tools, and conversations that will shape the next era of patient safety.
As the PV community looks forward to the 5th Edition Drug Safety Symposium 2026 - Middle East Chapter in January 2026, one thing remains clear: patient safety doesn't pause, and neither do we.
Pharma Quality Reimagined: Highlights from the 5th Annual Pharma GMP & Quality Management 2025
The pharma world came together once again at The Westin Mumbai Garden City on April 24th - 25th, 2025, for the highly anticipated 5th Annual Pharma GMP & Quality Management 2025, hosted by Eminence Group. Against the buzzing backdrop of Mumbai, industry leaders, innovators, and regulators convened to explore the future of quality, compliance, and digital transformation in life sciences.
From insightf... morePharma Quality Reimagined: Highlights from the 5th Annual Pharma GMP & Quality Management 2025
The pharma world came together once again at The Westin Mumbai Garden City on April 24th - 25th, 2025, for the highly anticipated 5th Annual Pharma GMP & Quality Management 2025, hosted by Eminence Group. Against the buzzing backdrop of Mumbai, industry leaders, innovators, and regulators convened to explore the future of quality, compliance, and digital transformation in life sciences.
From insightful keynotes to lively workshops and deep-dive panels, the event lived up to its promise: "Empowering the Pharma Industry for Tomorrow."
Ms. Guneet Kaur Hayer, Managing Director of Eminence Group, welcomed the audience with a stirring address emphasizing the need for proactive quality strategies, workforce transformation, and embracing digital evolution.
Key Themes and Memorable Conversations
The first morning took off with Dr. Damodharan M from Sai Life Sciences, who offered a panoramic view of how evolving global GMP regulations are shaping the compliance landscape. His session urged companies to prepare not just for today's audits, but for a future driven by sustainability and technological integration.
Immediately after, Aditya Chaudhary from Hexagon ETQ explored the digital revolution within pharma QMS. He emphasized how cloud-based, integrated systems could future proof organizations by automating regulatory reporting and enhancing traceability.
Learning by Doing: Workshops that Engaged
The conference shifted gears into practical learning with Ken Shitamoto from Gilead Lifesciences leading a mock inspection session. Attendees, role-playing as inspectors and auditees, learned firsthand what regulators scrutinize from documentation practices to operational transparency.
Building on this, Digambar Nigade from Amneal Pharma navigated participants through actual recent FDA 483 observations. He dissected real-world pitfalls and helped attendees shape strategies for avoiding compliance gaps.
Meanwhile, leaders from Veeva Systems, Varadarajan Srinivasan and Pradeep Nagisetty, shared inspiring case studies on migrating from outdated, siloed quality systems to integrated cloud-based platforms proving that digital transformation is not optional, it is essential.
Real-World Insights: Risk Management and Deviation Handling
Dr. Udaykumar Rakibe (Pharma Mantra) took a practical approach to Quality Risk Management, using live case studies to demonstrate how frameworks like FMEA and HACCP should be applied across pharma processes.
In a hands-on workshop, Prashanth GN of Granules India immersed attendees into the nuances of deviation management. Through group activities, participants tackled real-world scenarios, strengthened their root cause analysis skills, and discussed best practices for CAPA documentation.
As the day wrapped up, Ranjit Barshikar (CEO, ObD International) delivered an impassioned session on building a culture of quality by strengthening internal teams through structured training and skill-gap assessments.
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Day 2: The Future Beckons — Smart Labs, Gen AI, and Cyber Resilience
Day 2 opened with a fascinating live case study from Dr. Amjad Basha (Dr. Reddy’s Labs) on smart lab transformation. His real-world example of digitizing R&D environments offered practical lessons on overcoming adoption challenges.
The technology thread continued with a high-energy panel led by Archimedis Digital's leadership team starting with Duraisamy Rajan Palani, Anand Govindarajan, and Jeyashri Thivari exploring how AI, digital twins, and augmented reality are revolutionizing quality assurance and compliance.
A pivotal moment arrived with the star-studded panel featuring Ken Shitamoto, Abhijit S. Kulkarni (Lupin Limited), Shirish Ambulgekar (Alkem Laboratories), and Amit Malviya (Zest Pharma). They passionately debated how Gen AI is transforming the pharma workforce, operational efficiency, and supplier management, while cautioning about responsible adoption.
AV Jayakumar from Ajanta Pharma shifted the spotlight onto contamination control, detailing how companies can align with the revised EU GMP Annex 1 by building robust Contamination Control Strategies (CCS) based on risk assessment and facility design principles.
In a refreshing break from technical discussions, the audience participated in the #EminenceDigitalDetox session. A unique wellness initiative by Eminence Business Media aimed at boosting mental agility and resilience in high-pressure GMP environments.
Closing the day was a critical conversation on cybersecurity. Guneet Kaur Hayer, along with leaders like Dr. A.R.M. Rao (Aurobindo Pharma), Chitti Babu (Aurobindo Pharma), Sanjeev Mahajan (Innova Captab), and Pushkar Lakhekar (Cohance Lifesciences), outlined best practices for building cyber-resilient Quality Management Systems in an increasingly digitalized pharma world.
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Acknowledgments: Celebrating Partnerships and Collaborations
Eminence Group extends heartfelt gratitude to all event partners whose support made this conference possible:
• Gold Partner: Veeva Systems
• Digital Transformation Partner: Archimedis Digital
• Silver Partner: Hexagon ETQ
• Exhibit Partners: Arcolab, Astakenis, Mactus Automation Pvt. Ltd., SEEK and AmpleLogic
Their contribution not only fuelled the event's success but also underscored the collaborative spirit needed to transform pharma's future.
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Moving Forward Together
As the conference concluded, one thing was clear: the future of pharma quality will be shaped by those who embrace innovation, invest in people, and stay agile in a rapidly evolving regulatory environment.
The Eminence Group thanks all participants, speakers, and partners for making the 5th Annual Pharma GMP & Quality Management 2025 a resounding success and looks forward to an even more transformative 6th edition in 2026!
