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Conference Overview
Unlocking the Future of Clinical Trials
The 17th Annual Clinical Trials Summit 2026 serves as India’s premier platform to explore rapid market expansion and cutting-edge research innovations. Join global industry leaders to bridge the gap between regulatory intent and real-world execution through patient-centric trial design.
Decentralised Trials (DCTs)
Evaluate the transition toward remote trial models while balancing innovation, cost-efficiency, and patient access.
Regulatory Reforms
Discuss the latest updates on ICH GCP E6(R3) guidelines and streamlined approval pathways in the Asia-Pacific region.
Technology and AI
Discover how artificial intelligence and digital tools are transforming trial design, data analysis, and success rates.
Inspection Readiness
Learn to build robust compliance frameworks and risk monitoring strategies to meet post-pandemic regulatory expectations.
Patient Centricity
Focus on integrating safety, trust, and prioritized patient needs into every stage of the clinical research ecosystem.
Real-World Evidence (RWE)
Learn how to harness RWD to answer critical questions and improve structured benefit-risk assessments.
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Bridging Innovation & Integrity: Shaping the Future of Patient-Centric Clinical Trials
India’s clinical trial market is expanding rapidly, valued at up to USD 2.1 billion in 2025 and projected to reach USD 4.3 billion by 2033. As a premier global research hub, India is leveraging a diverse patient population and regulatory streamlining to drive an 8-9% CAGR. The 17th Annual Clinical Trials Summit 2026 serves as a vital platform for professionals to explore future advancements, from decentralized trials to AI-driven designs. By fostering collaboration between industry leaders, academia, and regulatory bodies, the summit addresses real-world challenges in trial execution. Attendees will gain exclusive insights into the evolving healthcare outsourcing landscape and emerging patient-centric innovations.
Speakers
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Hrs NETWORKING
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5 reasons to attend the events
We Simplify Planning, Boost Engagement, And Create Unforgettable Experiences.
Expert Insights
Learn from world-class leaders and high-level speakers across the clinical research ecosystem. Gain specialized knowledge on the latest business models and strategic industry developments.
Strategic Networking
Enjoy dedicated networking time to connect with decision-makers and global peers. Meet leading international vendors showcasing future products in the co-located exhibition.
Market Intelligence
Explore the rapidly expanding Indian clinical trial market, projected to reach up to USD 4.3 billion by 2033. Understand the growth drivers, including digital adoption and regulatory streamlining in the Asia-Pacific region.
Regulatory Mastery
Engage in deep dives regarding ICH GCP E6(R3) implementation and evolving regulatory reforms in India. Access practical strategies for maintaining inspection readiness and a culture of compliance.
Innovation Spotlight
Discover how AI and emerging technologies are transforming trial design and execution. Stay updated on cutting-edge trends like Decentralised Clinical Trials (DCTs) and Real-World Evidence (RWE).
Meet Our Expert Speakers
Industry leaders, regulators, and innovators sharing insights that are shaping the future of global healthcare and pharmacovigilance
OUR EVENT SCHEDULE
08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues.
09:20 – Welcome Address
CHALLENGES & OPPORTUNITIES
09:30 – “ICH GCP E6(R3): Bridging the Gap Between Guideline Intent and Real‑World Implementation”
- 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
DIVAKAR KOLLI
Director - Development Quality Assurance
Cipla
DECENTRALISATION
10:00 – Keynote Panel Discussion: Decentralised Clinical Trials at a Crossroads: Balancing Innovation, Cost, and Access
Moderator
OMPRAKASH S. SADHWANI
Former Joint Commissioner & Controlling Authority
FDA (Maharashtra State)
Panellists
VAIBHAV SALVI
Director & Head – Clinical Study Unit, India & South
East Asia,
Sanofi
AMARNATH SUGUMARAN
Director Medical Affairs
Cipla
BAIDYANATH MISHRA
Head- R&D Healthcare, Medical Affairs & Clinical
Research,
Dabur
NEELAKANT KRISHNAN
Sr. GM - Head Global Trial Management
Sun Pharma
10:50 – Morning Coffee/Tea & Discussion
PATIENT CENTRICITY
11:20 – DISCUSSION WITH EXPERTS: Putting Patients First: Integrating Safety, Trust, and Design Across Clinical Trials
Moderator
DYOTONA SEN
Head - Medical Affairs & Clinical Research
Galderma
Panellists
RAMESH JAGANNATHAN
VP, Medical Dept, Clinical Research & PV,
Bharat Serums and Vaccines
RAJENDRA KUMAR KASI
VP & Global Head – Pharmacovigilance
Glenmark Pharmaceuticals
RISHI JAIN
Country Medical Head
Novartis
MOHIT TRIVEDI
Country Safety Head India,
Sanofi
12:10 – Reserved for Principal/ Platinum Partner
For sponsorship opportunities please contact
12:40 –Networking luncheon
SPONSOR – SITE – CRO – PATIENTS – REGULATORS
13:50 – DISCUSSION WITH EXPERTS: Sponsors, Sites, CROs, Patients, and Regulators - From Silos to Synergy: Working Together to Accelerate Clinical Trials
Moderator
HEATHER LEIGH FLANNERY
CEO & Co-Founder
AI MINDSystems Foundation
Panellists
KEDAR NAYAK
Director - Global Study Management,
GSK
SHAILENDRA SACHAN
Director - Clinical Operations
Teva Pharmaceuticals
K. MURUGANANTHAN
Head - Study & Site Operations(SSO India), Global
Clinical Operation(GCO),
Novartis
ASHWANI PANDITA
Sr. GM Quality Management & Training, Global Clinical
Research Operations,
Glenmark Pharmaceuticals
PRASHANT MEHROTRA
Senior GM - Clinical Research
Bharat Serums and Vaccines
14:40 - Clinical Trials of Biosimilars and Antibody drug conjugates (ADCs)- Strategies and Updates
- Optimizing clinical confirmation strategies
- Early-phase dose optimization & biomarker selection
- Totality-of-evidence approach & indication extrapolation with Biosimilars
- Immunogenicity, switching, and real-world evidence
- Managing complex safety profiles
- Accelerated development and regulatory pathways
SHUBHADEEP SINHA
SVP, Head - Clinical Development & Medical Affairs (CD&MA)
Hetero Labs
15:10 – Afternoon Tea/Coffee
15:40 – Innovative methods for Clinical trial design
- Contemporary strategies to improve clinical trial design
- Setting up the best position to sustain an agile procedure for your study design
- The flexibility to redesign clinical trials at an intermediate stage
- How does AI transform key steps of clinical trial design from study preparation to execution towards improving trial success rates?
- Effective trial design and improved compliance
DO IT RIGHT – OUTSOURCING / PARTNERSHIPS
16:10 – DISCUSSION WITH EXPERTS: From Vendors to Partners: Redefining Outsourcing in Clinical Trials. Building Strategic Partnerships for Clinical Trial Success
Moderator
RANJIT BARSHIKAR
CEO
QBD International, United Nations Adviser
Panellists
ANIL KUKREJA
Executive VP - Clinical Research & Medical Affairs,
Emcure Pharmaceuticals
KHOKAN DEBNATH
Head of Regulatory Affairs, Clinical Operations &
Pharmacovigilance,
Wockhardt
ANUPRITA SHETH
Associate Director Vendor Oversight Lead,
Kenvue
JYOTSNA PATWARDHAN
Cluster Head Clinical/PV Country Quality Middle
East/Africa/Turkey/India,
Novartis
EMRAN KHAN
Global Clinical Operations Leader, Trial
Governance, Strategic Outsourcing,
Sun Pharma
17:00 – End of conference Day 01
08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues.
INSPECTION READINESS
09:30 - What to expect when you’re inspected?
- Key Learnings from recent inspections to smoothen your inspection readiness plan
- Different approaches to inspection readiness and how these vary across companies and regulatory updates?
- Authorities interactions and how inspections have been conducted pre- and post-pandemic?
- Building a readiness framework that takes into account new technologies and disruptors such as legislative changes, gene therapies, digital health and DCTs.
WENDY ERLER
SVP Patient Affairs Sarepta Therapeutics
EDDIE DARTON
VP - Head Global PV & Risk Management Sarepta Therapeutics
IMPACT OF TECHNOLOGY
10:00 – Keynote Panel Discussion: Technology and Innovation in Clinical Trials: Turning Potential into Practice. Opportunities, Risks, and Reality. AI & other Emerging Tech
Moderator
RASHMI HEGDE
Former VP Medical Affairs
GSK
Panellists
SANTOSH TAUR
Director Medical Affairs - Vaccines & Digital, Pfizer
RAJESH KHER
Director, Integrated Business Operations, Janssen Pharmaceutical
SIVA KUMAR BUDDHA
Medical Director Global Patient Safety, Amgen
SUCHITA MORE
Director V&I Medical Modernization, MSD
PROTITI BAGCHI
Associate Director - Global lead for Content & Marketing Operations and CX | Digital Transformation, GSK
MANGALA KOTNIS
Former Head Regional Medical Affairs, Abbott
10:50 – Morning Coffee/Tea & Discussion
RWE & RWD
11:20 – DISCUSSION WITH EXPERTS: From Data to Decisions: Unlocking the Value of RWE and RWD in Modern Clinical Trials. What It Really Takes to Use Them Right?
Moderator
KAVITA LAMROR
Partner, RWE & Digital Transformation
Maxis Clinical
Panellists
SHALINI MENON
Executive VP Medical Affairs, GSK
JAMAL BAIG
Director Drug Safety, MSD
PANKAJ THAKUR
Sr GM & Head Project Management, Hetero Labs
MAYUR MAYBHATE
Head Medical Affairs, Alkem Laboratories
DYOTONA SEN
Head - Medical Affairs & Clinical Research, Galderma
SHRADDHA BHANGE
Senior Medical Safety Lead, Sandoz
12:10 – Reserved for Platinum / Gold Partner
For sponsorship opportunities please contact
12:40 – Networking luncheon
COMPLIANCE / INSPECTION / RISK MANAGEMENT
13:50 – DISCUSSION WITH EXPERTS: Staying Inspection-Ready - From Risk to Readiness: Building a Culture of Compliance in Clinical Trials
Moderator
RENUKA NEOGI
Head & Deputy GM – Global Clinical Quality Management
Sun Pharma
Panellists
SWAPNALI RAUT
Director, Global Clinical Operations, GSK
RUTEJA JOGLEKAR
Director Site Management & Monitoring, AstraZeneca
SOURABH FULMALI
Global Medical Director – Respiratory, Allergy, CVS, GSK
KAPIL MEHTA
Head Medical Affairs, JB Pharmaceuticals
AMANDEEP KAUR TENEJA
Global Aggregate Reporting & RMP Manager, Kenvue
RBQM
14:40 – Risk-Based Quality Management (RBQM) and Centralized Monitoring in Clinical Trials
- Increasing complexity of clinical trial data and the need for stronger quality oversight.
- Centralized Monitoring (CM) supporting RBQM through CtQFs, KRIs, and QTLs.
- Proactive detection of risks and outliers to improve trial data reliability and subject safety.
- Case studies demonstrating practical application of RBQM principles.
- Regulatory, statistical, and implementation aspects of RBQM in modern clinical trials.
PRIYANGSHU CHOWDHURY
Centralized Monitoring (RBQM)
GSK
BISMITA BORKAKOTY
Central Monitoring Associate
GSK
15:10 – Afternoon Tea/Coffee
15:30 – Pediatric Clinical Trials in India: Challenges & the Way Forward
- Overview of the current pediatric clinical trial landscape in India and regulatory framework
- Key challenges including ethical considerations, consent, recruitment, and data gaps
- Existing approval pathways: extrapolation, global data acceptance, and post-marketing evidence
- Strategic way forward focusing on local trials, regulatory strengthening, and safety monitoring
PARIMA DALAL
Clinical Scientist ( Manager), Clinical Research Group, Torrent Pharma
Torrent Pharma
16:00 – Keynote Panel Discussion: Advancing Clinical Trials in India: Enabling Faster and Safer Clinical Trials. Regulatory Reforms Shaping the Future.
Moderator
MILIND ANTANI
Leader, Pharma and Healthcare
Nishith Desai Associates
Panellists
MAYUR PARMAR
Drugs Inspector (Deputy Collector, Gujarat Government), FDA
PRABHAT SINHA
Director Government & Public Affairs, Boehringer Ingelheim
KEDAR SUVARNAPATHAKI
Director Regulatory Affairs - Southeast Asia & India, Johnson & Johnson
AKSHAYA ODAK
Head Regulatory Affairs (Biotech), Lupin
MARTINA GOMES
Head, Reg Affairs – CH, Bayer
HARSHAD KOTHAWADE
Former Head of Regulatory Management & Trade Compliance, Merck Group
17:00 – 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 17th Annual Clinical Trials Summit 2026
Exhibitor
Gold Sponsors
silver Sponsors
Event Venue
World Trade Center (WTC)
Mumbai
India
022 6638 7272
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Pricing Details
Exclusive Deal: 3 for the Price of 2! - Limited time offer with limited seats only.
SUPER EARLY BIRD
PRICE — INR 15,000 + GST (18%) PER DELEGATE (Valid till 10 April 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 Taj President Hotel” during the conference dates, which is conveniently located next to the conference venue at the World Trade Centre.
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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