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Conference Overview
The 42nd Pharmacovigilance India 2026 serves as a premier platform for industry leaders to exchange insights and strengthen safety strategies within India’s rapidly evolving drug safety landscape. The event focuses on the future of pharmacovigilance, highlighting the integration of digital innovation and robust regulatory oversight to support the global pharmaceutical industry.
Digital Transformation
The conference explores how AI-driven signal detection, automation, and machine learning are redesigning pharmacovigilance. Sessions will examine the shift from periodic reviews to continuous risk intelligence through human-AI collaboration.
Regulatory Evolution
Experts will discuss driving compliance and collaboration between industry and regulators to achieve safer drugs. The agenda includes navigating global regulatory trends and the evolving ecosystem of combination products.
Risk Management
Attendees will focus on strengthening benefit-risk frameworks and reimagining risk management in PV. This includes exploring new approaches to drug safety to ensure enhanced patient protection.
Outsourcing Strategies
The event addresses the future of pharmacovigilance outsourcing, specifically balancing efficiency, quality, and compliance. It also highlights India’s growing role as a global hub for these critical outsourced services.
Data Intelligence
A major focus is placed on the growing role of Real-World Evidence (RWE) and Real-World Data (RWD) in modern drug safety. Professionals will learn how to harness these data sources to strengthen patient safety and clinical research.
Audit Readiness
Participants will learn to plan, develop, and implement robust PV audit strategies to ensure continuous inspection readiness. Discussions will cover common inspection findings and leveraging digital tools for compliance oversight.
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42nd Pharmacovigilance India 2026: Navigating the Future of Drug Safety
The 42nd Pharmacovigilance India 2026, presented by Virtue Insight, convenes on 23 July 2026 at the Radisson in Hyderabad. As India’s PV market is projected to exceed USD 700 million by 2033, this forum addresses the critical need for robust safety surveillance. Industry leaders from global giants like Amgen, Novartis, and Pfizer will share strategic insights on digital transformation. Attendees will explore high-impact topics including AI-driven signal detection, RWE, and evolving regulatory frameworks. This conference offers a unique, discussion-driven environment designed to strengthen safety strategies and foster elite partnerships across the pharmaceutical ecosystem
Speakers
Attendees
Hrs NETWORKING
SESSIONS
OUR ATTENDEES
Trusted by Industry Leaders Worldwide
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5 reasons to attend the events
Harness the power of AI-driven innovation and strategic global partnerships to redefine the future of drug safety. Join industry pioneers in Hyderabad to navigate evolving regulatory landscapes and ensure unparalleled patient protection in the digital age.
Elite Networking
Connect with senior-level executives and decision-makers from global leaders like Amgen, Novartis, and Pfizer in a focused, discussion-driven environment.
AI Integration
Explore how intelligent drug safety and autonomous signal intelligence are redesigning pharmacovigilance workflows through human-AI collaboration.
Regulatory Mastery
Gain critical updates on global regulatory trends, combination products, and strategies for achieving continuous inspection readiness.
Strategic Outsourcing
Evaluate the future of PV outsourcing in India, focusing on balancing operational efficiency with high-quality compliance standards.
Data-Driven Safety
Learn to harness Real-World Evidence (RWD/RWE) and advanced risk management frameworks to strengthen benefit-risk outcomes for patients
Meet Our Expert Speakers
OUR EVENT SCHEDULE
08:30 – Coffee and Registration – An opportunity to meet, greet & network with your conference colleagues.
09:00 – Welcome address and Opening Remarks
Speaker TBC
Clinevo Technologies
DIVAKAR KOLLI
Cipla
09:05 – Special Address by the Guest of Honour
- Understanding the True Intent of ICH E6(R3)
- Identifying Current Implementation Gaps
- Commonly Overlooked Elements in R3
- Practical Barriers Across Sponsors, CROs, and Sites
- Actionable Strategies to Bridge the Gap
SARVESH SINGH
Telangana Lifesciences
GLOBAL ECOSYSTEM / COMBINATION PRODUCTS
09:20 – Keynote Address – The evolving Global Ecosystem and world of Combination Products
Explore the definitions and global regulatory trends currently shaping the combination products ecosystem. Highlighting the universal challenges
impacting industry stakeholders, regulators, and suppliers, while sharing best practices for navigating future innovations and ecosystem shifts. Emphasize
the role India (People, Process and Technology) plays in the evolution
KHAUDEJA BANO
Roche – Genentech (USA)
09:50 – Keynote- Intelligent Drug Safety: How AI is Redesigning Pharmacovigilance
Explore the definitions and global regulatory trends currently shaping the combination products ecosystem. Highlighting the universal challenges
impacting industry stakeholders, regulators, and suppliers, while sharing best practices for navigating future innovations and ecosystem shifts. Emphasize
the role India (People, Process and Technology) plays in the evolution
SIVA KUMAR BUDDHA
Amgen
TRNSFORMING PV OUTSOURCING
10:10 - Keynote Panel Discussion – Future of Pharmacovigilance Outsourcing: Balancing efficiency, quality, and compliance. India as a global Hub for Pharmacovigilance Outsourcing
Moderator
SIVA KUMAR BUDDHA
Amgen
Panellists
PRASAD DESHMUKH
Cipla
RAJESH RAJENDRAN
Pfizer
JOSE ALBERTO AYALA ORTIZ
PVpharm (Spain)
SAILAJA SAYANA
Sandoz
10:40 – MORNING COFFEE/TEA & NETWORKING
RMP – INNOVATION, INSIGHTS, IMPACT
11:10 – Discussion With Experts – Reimagining Risk Management in PV. Strengthening Benefit–Risk Frameworks for Safer Medicines & new approaches in drug safety & risk management
Moderator
KABIL KALATHINGAL
Dr. Reddy’s Laboratories
Panellists
KABIL KALATHINGAL
Dr. Reddy’s Laboratories
MOHIT TRIVEDI
Sanofi
DEVANG PATEL
Zydus Group
11:50 – Topic TBC
Speaker TBC
Clinevo Technologies
JASON BRYANT
CSL Behring
12:15 – Topic TBC
Speaker TBC
Clinevo Technologies
JASON BRYANT
CSL Behring
12:30 – Networking luncheon
GCC IN PHARMA / DIGITAL TRANSFORMATION
13:20 – Discussion With Experts – Driving AI, automation, & the future of PV. GCCs in the Digital Age: How GCCs are powering the next generation of drug safety? From back office to innovation hub
Moderator
ASHISH DWIVEDI
Synapmed
Panellists
KIRAN KANDULA
Astrazeneca
NUPUR SONI
Amgen
VIKRAM K
Bristol Myers Squibb
SHWETHA SUBRAMANYA
Novartis
AUDITS / INSPECTION
14:00 – PV Audits & Inspections - Plan, Develop & Implement the PV Audit strategy plan. PV Inspection readiness: What to expect? How ready can we be?
- Ensuring Compliance, Quality, and Continuous Improvement
- Common pharmacovigilance inspection findings and how organizations can proactively address them
- Building a robust PV (QMS) to support inspection readiness
- Leveraging technology and digital tools to improve audit tracking, CAPA management, and compliance oversight
- Creating a culture of continuous inspection readiness and quality excellence in pharmacovigilance operations
SHUBHADEEP SINHA
Hetero Labs
SIGNAL
14:30 – Autonomous Signal Intelligence: Reimagining Signal Management through Human–AI Collaboration
- AI agents continuously monitor multiple safety data sources to detect emerging signals early.
- AI supports rapid triage, prioritization, and evidence synthesis at scale.
- Experts apply clinical judgment to validate and interpret AI-generated insights.
- Transparent and auditable AI workflows support regulatory confidence.
- Enabling a shift from periodic signal review to continuous risk intelligence.
SHUBHADEEP SINHA
Hetero Labs
14:50 – Afternoon Coffee/Tea & Networking
GROWING ROLE OF RWE / RWD
15:20 – Discussion With Experts – Role of RWE in Modern Pharmacovigilance. RWD in Drug Safety: Opportunities, Challenges. Harnessing them to strengthen PV and patient safety
Moderator
RANJIT BARSHIKAR
QBD International, United Nations Adviser
Panellists
HANUMANTHA RAO KAREDLA
Amgen
PRANAV SIKKA
Novartis
SHRADDHA BHANGE
Sandoz
EMRAN KHAN
Sun Pharma Advanced Research Company
PADMA BALAKRISHNAN
Knowledgeworks Innovative Linguistic Solutions
HARMONIZING PV REGULATIONS
16:00 – Discussion With Experts – Regulatory Evolution in Pharmacovigilance: Driving Compliance, Collaboration, & Innovation. Collaboration between Industry & Regulators to achieve safer drugs for patients’ safety.
Moderator
VIJAY KRISHNAN
Opella
Panellists
RAJENDRA KASI
Glenmark
NITU SINHA
Mankind Pharma
PADMA BALAKRISHNAN
Knowledgeworks Innovative Linguistic Solutions
EMRAN KHAN
Sun Pharma Advanced Research Company
PADMA BALAKRISHNAN
Knowledgeworks Innovative Linguistic Solutions
16:40 – Closing remarks and end of conference
14:50 - Re-imagining Dossier Authoring: From Manual Compilation to AI-Assisted Authoring and Lifecycle Management
- AI-driven automation in dossier creation: Transition from time-consuming manual compilation to intelligent automation where AI tools structure, draft, and validate regulatory dossiers using pre-designed templates as per ICH guidelines and real-time data processing.
- Enhanced compliance and efficiency: AI-assisted authoring ensures alignment with global regulatory standards (e.g., EMA, USFDA, CDSCO) by auto-updating changes in guidance and improving accuracy, traceability, and submission timelines.
- Lifecycle intelligence and version management: Integrating AI into the dossier lifecycle enables continuous monitoring, smart version control, and predictive updates across product changes, fostering a fully connected regulatory ecosystem.
MANASA KASIVAJJULA
CEO and Co-Founder
DeepForrest.ai (A CtrlS Company)
OUR EVENT SCHEDULE
Meet to learn and network with your conference colleagues.
08:30 – Coffee and Registration – An opportunity to meet, greet & network with your conference colleagues.
09:00 – Welcome address and Opening Remarks
Speaker TBC
Clinevo Technologies
09:05 – Special Address by the Guest of Honour
- Understanding the True Intent of ICH E6(R3)
- Identifying Current Implementation Gaps
- Commonly Overlooked Elements in R3
- Practical Barriers Across Sponsors, CROs, and Sites
- Actionable Strategies to Bridge the Gap
SARVESH SINGH
Director & CEO
Telangana Lifesciences
GLOBAL ECOSYSTEM / COMBINATION PRODUCTS
09:20 – Keynote Address – The evolving Global Ecosystem and world of Combination Products
Explore the definitions and global regulatory trends currently shaping the combination products ecosystem. Highlighting the universal challenges impacting industry stakeholders, regulators, and suppliers, while sharing best practices for navigating future innovations and ecosystem shifts. Emphasize the role India (People, Process and Technology) plays in the evolution
KHAUDEJA BANO
VP - Global Head of Device Quality
Roche – Genentech (USA)
09:50 – Keynote- Intelligent Drug Safety: How AI is Redesigning Pharmacovigilance
- Understanding the True Intent of ICH E6(R3)
- Identifying Current Implementation Gaps
- Commonly Overlooked Elements in R3
- Practical Barriers Across Sponsors, CROs, and Sites
- Actionable Strategies to Bridge the Gap
SIVA KUMAR BUDDHA
Medical Director Global Patient Safety
Amgen
TRNSFORMING PV OUTSOURCING
10:10 - KEYNOTE PANEL DISCUSSION – Future of Pharmacovigilance Outsourcing: Balancing efficiency, quality, and compliance. India as a global Hub for Pharmacovigilance Outsourcing
Moderator
SIVA KUMAR BUDDHA
Medical Director Global Patient Safety
Amgen
Panellists
PRASAD DESHMUKH
Vice President- Head Pharmacovigilance,
Cipla
RAJESH RAJENDRAN
Director, Projects and Vendor Management Team
Lead,
Pfizer
JOSE ALBERTO AYALA ORTIZ
CEO
PVpharm (Spain)
SAILAJA SAYANA
Medical Safety Group Head,
Sandoz
10:40 – MORNING COFFEE/TEA & NETWORKING
RMP – INNOVATION, INSIGHTS, IMPACT
11:10 – DISCUSSION WITH EXPERTS – Reimagining Risk Management in PV. Strengthening Benefit–Risk Frameworks for Safer Medicines & new approaches in drug safety & risk management
Moderator
DYOTONA SEN
Head - Medical Affairs & Clinical Research
Galderma
Panellists
KABIL KALATHINGAL
Global Head - Medical Assessment, Compliance and
Digitalization,
Dr. Reddy’s Laboratories
MOHIT TRIVEDI
Country Safety Head India,
Sanofi
DEVANG PATEL
Head of Pharmacovigilance
Zydus Group
MOHIT TRIVEDI
Country Safety Head India,
Sanofi
11:50 – Topic TBC
Speaker TBC
Clinevo Technologies
12:15 – Topic TBC
12:30 – Networking luncheon
GCC IN PHARMA / DIGITAL TRANSFORMATION
13:20 – DISCUSSION WITH EXPERTS – Driving AI, automation, & the future of PV. GCCs in the Digital Age: How GCCs are powering the next generation of drug safety? From back office to innovation hub
Moderator
ASHISH DWIVEDI
Chief Customer Officer
Synapmed
Panellists
KIRAN KANDULA
Senior Director - GBS Patient Safety,
Astrazeneca
NUPUR SONI
Director Technology R&D, Global Patient Safety,
Amgen
VIKRAM K
Director PvOpS,
Bristol Myers Squibb
SHWETHA SUBRAMANYA
Site Head Patient Safety and Pharmacovigilance,
Novartis
AUDITS / INSPECTION
14:00 – PV Audits & Inspections - Plan, Develop & Implement the PV Audit strategy plan. PV Inspection readiness: What to expect? How ready can we be?
- Ensuring Compliance, Quality, and Continuous Improvement
- Common pharmacovigilance inspection findings and how organizations can proactively address them
- Building a robust PV (QMS) to support inspection readiness
- Leveraging technology and digital tools to improve audit tracking, CAPA management, and compliance oversight
- Creating a culture of continuous inspection readiness and quality excellence in pharmacovigilance operations
SHUBHADEEP SINHA
SVP, Head - Clinical Development & Medical Affairs (CD&MA)
Hetero Labs
SIGNAL
14:30 – Autonomous Signal Intelligence: Reimagining Signal Management through Human–AI Collaboration
- AI agents continuously monitor multiple safety data sources to detect emerging signals early.
- AI supports rapid triage, prioritization, and evidence synthesis at scale.
- Experts apply clinical judgment to validate and interpret AI-generated insights.
- Transparent and auditable AI workflows support regulatory confidence.
SHUBHADEEP SINHA
SVP, Head - Clinical Development & Medical Affairs (CD&MA)
Hetero Labs
14:50 – Afternoon Coffee/Tea & Networking
GROWING ROLE OF RWE / RWD
15:20 – DISCUSSION WITH EXPERTS – Role of RWE in Modern Pharmacovigilance. RWD in Drug Safety: Opportunities, Challenges. Harnessing them to strengthen PV and patient safety
Moderator
SIVA KUMAR BUDDHA
Medical Director Global Patient Safety
Amgen
Panellists
HANUMANTHA RAO KAREDLA
Director, Center for Observational Research (CfOR),
Amgen
PRANAV SIKKA
Global Head, Safety Signal Detection & MedDRA
Query Management,
Novartis
SHRADDHA BHANGE
Senior Medical Safety Lead,
Sandoz
HARMONIZING PV REGULATIONS
16:00 – DISCUSSION WITH EXPERTS – Regulatory Evolution in Pharmacovigilance: Driving Compliance, Collaboration, & Innovation. Collaboration between Industry & Regulators to achieve safer drugs for patients’ safety.
Moderator
VIJAY KRISHNAN
Global Safety Operational Group Lead
Opella
Panellists
RAJENDRA KASI
VP & Global Head – Pharmacovigilance,
Glenmark
NITU SINHA
Vice President & Head Pharmacovigilance,
Mankind Pharma
PADMA BALAKRISHNAN
CEO And Co Founder,
Knowledgeworks Innovative Linguistic Solutions
16:40 – Closing remarks and end of conference
Our Partners
We sincerely thank the following organizations and individuals for generously contributing their time, financial support, ideas, and dedication toward the successful conduct of the 42nd pharmacovigilance india 2026
Principle Partner
Gold Partner
Silver Partner
Exhibitors
Academic Partner
Event Venue
Radisson Hyderabad Hitec City
Hyderabad
India
040 6769 6769
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Pricing Details
SUPER EARLY BIRD
PRICE — INR 10,000 + GST (18%) PER DELEGATE (Valid till 29 May 2026)
You can simply email or call and book your conference delegate seats on:
TEL: + 91 44 4210 8101 (or) Email — info@virtueinsight.com
Accommodation
We have secured special room rates for our conference participants who wish to stay at the conference venue hotel “Radisson” during the conference dates.
Once you confirm your participation, our operations team will share the room reservation details along with the booking deadline and the special rates we’ve arranged.
Event Testimonials
United Kingdom
Block 3, 86 Coombe Road
Croydon CR0 5RA
London, UK
Asia
Plot No – 07 – 2nd Floor
Ekambaram Industrial Estate
Alapakkam, Porur Chennai,
India – 600 116
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