17th Annual Clinical Trials Summit 2026
17th Annual Clinical Trials Summit 2026
10 & 11 June, 2026
World Trade Center (WTC), Mumbai, India
5 Reasons to attend the event
Knowledge
Gain insights from experts, researchers, and professionals to stay updated on the latest pharma advancements.
Convenience
Attend sessions from anywhere, eliminating travel hassles while accessing high-quality content at your own pace.
Cutting-Edge Insights
Discover the latest trends, innovations, and breakthroughs shaping the future of the pharmaceutical industry.
Networking
Connect with peers, industry leaders, and collaborators to exchange ideas and explore new opportunities.
Practical Takeaways
Walk away with actionable strategies, real-world case studies, and learn best practices to implement in your work.
Knowledge
Gain insights from experts, researchers, and professionals on the latest pharma advancements.
An Agenda Made For You
High quality content that addresses your biggest challenges and uncovering hidden opportunities.
Cutting-Edge Insights
Explore the latest trends, innovations, and breakthroughs driving the future of the pharmaceutical industry.
Networking
Connect with peers, industry leaders, and collaborators to exchange ideas and explore new opportunities.
Practical Takeaways
Walk away with practical strategies, case studies, and proven best practices to apply in real-time.
Key Focus Areas
Event Speakers
MAYUR PARMAR
FDA
SHUBHADEEP SINHA
Hetero Labs
RAMESH JAGANNATHAN
Bharat Serums and Vaccines
ANIL KUKREJA
Emcure Pharmaceuticals
SHALINI MENON
GSK
RAJENDRA K K
Glenmark Pharmaceuticals
RAMANARAYANA PARHI
Alkem Labs
RUTEJA JOGLEKAR
AstraZeneca
SHAILENDRA S
Teva Pharmaceuticals
PRABHAT SINHA
Boehringer Ingelheim
RAJESH KHER
Janssen Pharmaceutical
SANTOSH TAUR
Pfizer
VAIBHAV SALVI
Sanofi
KEDAR S
Johnson & Johnson
KEDAR NAYAK
GSK
SIVA KUMAR B
Amgen
JAMAL BAIG
MSD
SWAPNALI RAUT
GSK
ANUPRITA SHETH
Kenvue
MOHIT TRIVEDI
Sanofi
EMRAN KHAN
Sun Pharma
DIVAKAR KOLLI
Cipla
SUCHITA MORE
MSD
SOURABH F
GSK
RISHI JAIN
Novartis
AMARNATH SUGUMARAN
Cipla
PROTITI BAGCHI
GSK
BAIDYANATH MISHRA
Dabur
DYOTONA SEN
Galderma
KAPIL MEHTA
JB Pharmaceuticals
JYOTSNA PATWARDHAN
Novartis
MARTINA GOMES
Bayer
K. MURUGANANTHAN
Novartis
KHOKAN DEBNATH
Wockhardt
PANKAJ THAKUR
Hetero Labs
AKSHAYA ODAK
Lupin
RENUKA NEOGI
Sun Pharma
MAYUR MAYBHATE
Alkem Laboratories
OMPRAKASH S. SADHWANI
Former FDA
RASHMI HEGDE
Former GSK
ASHWANI PANDITA
Glenmark Pharmaceuticals
PRASHANT MEHROTRA
Bharat Serums and Vaccines
SHRADDHA BHANGE
Sandoz
RANJIT BARSHIKAR
QBD International, United
Nations Adviser
PARIMA DALAL
Torrent Pharma
HARSHAD KOTHAWADE
Merck Group
NEELAKANT KRISHNAN
Sun Pharma
KAVITA LAMROR
Maxis Clinical Sciences
MANGALA KOTNIS
Abbott
AMANDEEP KAUR TENEJA
Kenvue
Event Schedule
Meet to learn and network with your conference colleagues.
08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues.
09:20 – Welcome Address
09:30 – “ICH GCP E6(R3): Bridging the Gap Between Guideline Intent and Real‑World Implementation”
CHALLENGES & OPPORTUNITIES
- 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
Speaker
DIVAKAR KOLLI
Director – Development Quality Assurance
Cipla
10:00 – Keynote Panel Discussion: Decentralised Clinical Trials at a Crossroads: Balancing Innovation, Cost, and Access
DECENTRALISATION
Moderator
OMPRAKASH S. SADHWANI
Former Joint Commissioner and controlling Authority
FDA (Maharashtra State)
Panellists
AMARNATH SUGUMARAN
Associate Director & Cluster Head Medical Affairs
Cipla
BAIDYANATH MISHRA
Head- R&D Healthcare, Medical Affairs & Clinical
Research, Dabur
NEELAKANT KRISHNAN
Sr. GM – Head Global Trial Management
Sun Pharma
AKSHAY ANIL MANDLECHA
Scientist (Officer – R&D)
Gennova Biopharmaceuticals
10:50 – Morning Coffee/Tea & Discussion
11:20 – DISCUSSION WITH EXPERTS: Putting Patients First: Integrating Safety, Trust, and Design Across Clinical Trials
PATIENT CETRICITY
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
AMARNATH SUGUMARAN
Director – Medical Affairs
Cipla
12:10 – Reserved for Principal/ Platinum Partner
For sponsorship opportunities please contact
info@virtueinsight.com
Speaker
SAMIR KULKARNI
Head – DBT ICT Center
Institute of Chemical Technology
12:40 – Networking luncheon
13:50 – DISCUSSION WITH EXPERTS: Sponsors, Sites, CROs, Patients, and Regulators - From Silos to Synergy: Working Together to Accelerate Clinical Trials
SPONSOR – SITE – CRO – PATIENTS – REGULATORS
Moderator
VISHWAS SOVANI
Founder Director
Pharmawisdom
Panellists
KEDAR NAYAK
Director – Global Study Management
GSK
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
Speaker
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?
Speaker
APARNA PRABHUNE
Deputy GM – Regulatory Affairs
Wockhardt
16:10 – DISCUSSION WITH EXPERTS: From Vendors to Partners: Redefining Outsourcing in Clinical Trials. Building Strategic Partnerships for Clinical Trial Success
DO IT RIGHT – OUTSOURCING / PARTNERSHIPS
Moderator
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.
09:20 – Welcome Address
09:30 – “ICH GCP E6(R3): Bridging the Gap Between Guideline Intent and Real‑World Implementation”
CHALLENGES & OPPORTUNITIES
- 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
Speaker
DIVAKAR KOLLI
Director – Development Quality Assurance
Cipla
10:00 – Keynote Panel Discussion: Decentralised Clinical Trials at a Crossroads: Balancing Innovation, Cost, and Access
DECENTRALISATION
Moderator
OMPRAKASH S. SADHWANI
Former Joint Commissioner and controlling Authority
FDA (Maharashtra State)
Panellists
AMARNATH SUGUMARAN
Associate Director & Cluster Head Medical Affairs
Cipla
BAIDYANATH MISHRA
Head- R&D Healthcare, Medical Affairs & Clinical
Research, Dabur
NEELAKANT KRISHNAN
Sr. GM – Head Global Trial Management
Sun Pharma
AKSHAY ANIL MANDLECHA
Scientist (Officer – R&D)
Gennova Biopharmaceuticals
10:50 – Morning Coffee/Tea & Discussion
11:20 – DISCUSSION WITH EXPERTS: Putting Patients First: Integrating Safety, Trust, and Design Across Clinical Trials
PATIENT CETRICITY
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
AMARNATH SUGUMARAN
Director – Medical Affairs
Cipla
12:10 – Reserved for Principal/ Platinum Partner
For sponsorship opportunities please contact
info@virtueinsight.com
Speaker
SAMIR KULKARNI
Head – DBT ICT Center
Institute of Chemical Technology
12:40 – Networking luncheon
13:50 – DISCUSSION WITH EXPERTS: Sponsors, Sites, CROs, Patients, and Regulators - From Silos to Synergy: Working Together to Accelerate Clinical Trials
SPONSOR – SITE – CRO – PATIENTS – REGULATORS
Moderator
VISHWAS SOVANI
Founder Director
Pharmawisdom
Panellists
KEDAR NAYAK
Director – Global Study Management
GSK
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
Speaker
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?
Speaker
APARNA PRABHUNE
Deputy GM – Regulatory Affairs
Wockhardt
16:10 – DISCUSSION WITH EXPERTS: From Vendors to Partners: Redefining Outsourcing in Clinical Trials. Building Strategic Partnerships for Clinical Trial Success
DO IT RIGHT – OUTSOURCING / PARTNERSHIPS
Moderator
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.
09:30 - What to expect when you’re inspected?
INSPECTION READINESS
- 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.
Speaker
DIVAKAR KOLLI
Director – Development Quality Assurance
Cipla
10:00 – Keynote Panel Discussion: Technology and Innovation in Clinical Trials: Turning Potential into Practice. Opportunities, Risks, and Reality. AI & other Emerging Tech
IMPACT OF TECHNOLOGY
Moderator
RASHMI HEGDE
Former VP Medical Affairs
GSK
Panellists
RAMANARAYANA PARHI
VP & CIO
Alkem Labs
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
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?
RWE & RWD
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
info@virtueinsight.com
Speaker
SAMIR KULKARNI
Head – DBT ICT Center
Institute of Chemical Technology
12:40 – Networking luncheon
13:50 – DISCUSSION WITH EXPERTS: Staying Inspection-Ready - From Risk to Readiness: Building a Culture of Compliance in Clinical Trials
COMPLIANCE / INSPECTION / RISK MANAGEMENT
Moderator
RENUKA NEOGI
Head & Deputy GM – Global Clinical Quality
Management, Sun Pharma
Panellists
SWAPNALI RAUT
Director, Global Clinical Operations
GSK
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
14:40 – Creating an effective clinical trial site management
SITE MANAGEMENT
- Find the tech you need for clinical trial site management
- Create a central hub for clinical trial site management
- Conduct remote monitoring visits
- Communicate often with the regulatory bodies
- Top issues that sites are focused on when conducting decentralized clinical trials and the possible solutions
Speaker
SHUBHADEEP SINHA
SVP, Head – Clinical Development & Medical Affairs
(CD&MA), Hetero Labs
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
Speaker
PARIMA DALAL
Clinical Scientist ( Manager), Clinical Research Group
Torrent Pharma
16:00 – Keynote Panel Discussion: Advancing Clinical Trials in India: Enabling Faster and Safer Clinical Trials. Regulatory Reforms Shaping the Future.
REGULATORY
Moderator
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
08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues.
09:30 - What to expect when you’re inspected?
INSPECTION READINESS
- 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.
Speaker
DIVAKAR KOLLI
Director – Development Quality Assurance
Cipla
10:00 – Keynote Panel Discussion: Technology and Innovation in Clinical Trials: Turning Potential into Practice. Opportunities, Risks, and Reality. AI & other Emerging Tech
IMPACT OF TECHNOLOGY
Moderator
RASHMI HEGDE
Former VP Medical Affairs
GSK
Panellists
RAMANARAYANA PARHI
VP & CIO
Alkem Labs
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
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?
RWE & RWD
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
info@virtueinsight.com
Speaker
SAMIR KULKARNI
Head – DBT ICT Center
Institute of Chemical Technology
12:40 – Networking luncheon
13:50 – DISCUSSION WITH EXPERTS: Staying Inspection-Ready - From Risk to Readiness: Building a Culture of Compliance in Clinical Trials
COMPLIANCE / INSPECTION / RISK MANAGEMENT
Moderator
RENUKA NEOGI
Head & Deputy GM – Global Clinical Quality
Management, Sun Pharma
Panellists
SWAPNALI RAUT
Director, Global Clinical Operations
GSK
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
14:40 – Creating an effective clinical trial site management
SITE MANAGEMENT
- Find the tech you need for clinical trial site management
- Create a central hub for clinical trial site management
- Conduct remote monitoring visits
- Communicate often with the regulatory bodies
- Top issues that sites are focused on when conducting decentralized clinical trials and the possible solutions
Speaker
SHUBHADEEP SINHA
SVP, Head – Clinical Development & Medical Affairs
(CD&MA), Hetero Labs
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
Speaker
PARIMA DALAL
Clinical Scientist ( Manager), Clinical Research Group
Torrent Pharma
16:00 – Keynote Panel Discussion: Advancing Clinical Trials in India: Enabling Faster and Safer Clinical Trials. Regulatory Reforms Shaping the Future.
REGULATORY
Moderator
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
Event Testimonials
A huge thanks to all our sponsors, attendees and partners!
Pricing Details
Exclusive Deal: 3 for the Price of 2! – Limited time offer with limited seats only
You can simply email or call and book your conference delegate seats on:
TEL: + 91 44 42108101 (or) Email — bookings@virtueinsight.com
CONFERENCE SPONSOR & EXHIBITION STALL
Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to:
TEL: + 91 44 42108101 (or) Email — bookings@virtueinsight.com
Venue Details
The venue is easily accessible, well-equipped with modern amenities, and offers a comfortable, professional setting for all attendees.
Venue
World Trade Center (WTC), Mumbai,
India
Cuffe Parade, Colaba, Mumbai,
Maharashtra – 400005, India
022 6638 7272
Venue
World Trade Center (WTC),
Mumbai, India
Cuffe Parade, Colaba, Mumbai,
Maharashtra – 400005, India
022 6638 7272
