16th Annual Clinical Trials Summit 2025
16th ANNUAL CLINICAL TRIALS SUMMIT 2025
11th & 12th June, 2025
Hotel Kohinoor Continental, 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.
Event Speakers
Ramesh J
Bharat Serums and Vaccines
Vipin Sethi
Cadila
Shalini M
GSK
AVIK GHOSH
Sun Pharma
Vaibhav S
Sanofi
Milind A
Nishith Desai Associates
Divakar K
Cipla
Priya R
GSK
SHILPA H R
Tech Observer
Sourabh F
GSK
PANKAJ THAKUR
Hetero Labs
Sailesh B
Medidata
Amarnath S
Cipla
Jamal Baig
Sanofi
Ashish G
Bayer
RICHARD L
Proteomics International
Sakshi S D
Johnson & Johnson
Nivedita T
Sanofi
JEROZE DALAL
GSK
AMIT PANDEY
GSK
Krunal D
GSK
Mukesh Gori
Amgen
Anup Pingle
GSK
Roshan P
Renuka N
Sun Pharma
Harshad K
Merck (Former)
Sadanand K
Fresenius Kabi
Vivek Gupta
Organon
RISHI JAIN
Novartis
Anuja J
Organon
K Murugananthan
Novartis
Prashant M
Bharat Serums and Vaccines
Mayur M
Alkem Laboratories
Martina G
Bayer
VINAYKUMAR N
Dr. Reddy’s Biologics
HARSHAD MALVE
Kenvue
Ashwani P
Glenmark Pharmaceuticals
Nishith Vyas
Novartis
Rashmi H
Gsk (Former)
Neelakant K
Sun Pharma
Vishvajit M K
Fresenius Kabi
Indranil P
Ipca Laboratories
Sakharam G
Renovare Healthcare
DEVEN BABRE
Fresh Gravity
Kavita L
Maxis Clinical Sciences
OMPRAKASH S S
FDA (Maharashtra State)
Rupesh Nehra
Pfizer
APARNA PRABHUNE
Wockhardt
Ganesh Kadhe
Zantus Lifesciences
KUSHAL SARDA
Shalina Healthcare
Mangala K
Abbott (Former)
Vishwas S
Pharma Wisdom
Download Brochure
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
09:30 – Welcome Address
09:40 – Innovative methods for Clinical trial design
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 to wards improving trial success rates?
- Effective trial design and improved compliance
Speaker
Roshan Pawar
Former Medical Lead
10:10 – DISCUSSION WITH EXPERTS: Working together to accelerate trials - SPONSOR – SITE – CRO – PATIENTS - REGULATORS - “Collaborate, Communicate, Accelerate.”
SPONSOR – SITE – CRO – PATIENTS – REGULATORS
- Sponsors and CROs: Building strong partnerships to align goals, share data, and streamline trial processes.
- Sites and Sponsors: Enhancing collaboration to address operational challenges and drive trial efficiency.
- Patients at the Core: Ensuring patient input and experience guide trial designs for better recruitment and retention.
- Regulators and Transparency: Promoting open communication to expedite approvals and maintain compliance.
- Cross-Stakeholder Synergy: Bridging gaps between all players to foster shared accountability and results.
- Leveraging Technology: Enabling real-time data sharing and collaboration across teams and geographies.
- Continuous Improvement: Using feedback and shared insights to refine processes and accelerate trial timelines.
Moderator
GANESH KADHE
Founder & Director
Zantus Lifesciences
Panellists
AVIK GHOSH
General Manager and Head Regional Clinical Operations
Sun Pharma
SADANAND KULKARNI
Head – Medical, Regulatory, Vigilance & Quality (South Asia)
Fresenius Kabi
MUKESH GORI
Director ESP Engagement PV & PS
Amgen
KRUNAL DALAL
Head Medical Affairs
GSK
PRASHANT MEHROTRA
Senior GM – Clinical Research
Bharat Serums and Vaccines
11:00 – Morning Coffee/Tea & Discussion
11:30 – DISCUSSION WITH EXPERTS: “Patients First, Always.” - Prioritising patients in trials – Bringing it all together to enhance the patient safety
PATIENT CENTRICITY
- Embedding Patient-Centric Practices: Strategies for integrating patient needs into every stage of clinical trials.
- Enhancing Patient Safety: Key measures to safeguard participants throughout the trial lifecycle.
- Improving Communication: Transparent, empathetic engagement to build trust and ensure informed participation.
- Customising Trial Designs: Adapting protocols to accommodate diverse patient populations and preferences.
- Leveraging Technology: Using digital tools to monitor, support, and ensure patient safety effectively.
- Evaluating Success: Metrics and feedback loops to assess and continuously improve patient-first initiatives in trials.
Moderator
VISHWAS SOVANI
Founder Director
Pharmawisdom
Panellists
RISHI JAIN
Country Medical Head
Novartis
MAYUR MAYBHATE
Head Medical Affairs
Alkem Laboratories
INDRANIL PURKAIT
Senior GM – Medical Affairs
Ipca Laboratories
HARSHAD MALVE
Medical Head – Self-Care & Operations
Kenvue
PANKAJ THAKUR
GM, Clinical Project Management – Drug Discovery, Biologics
Hetero Labs
12:20 – From Discovery to Delivery: Harnessing AI, Data Management & Digital Transformation to Optimize Drug Development
In the fast-changing life sciences landscape, Dassault Systèmes is transforming drug development by fusing cutting-edge technology with extensive scientific knowledge, data power, and artificial intelligence. With tools like Clinical Data Studio for smooth data integration and compliance and Simulant for AI-powered trial optimization, Medidata propels clinical innovation. BIOVIA ensures manufacturing quality control while improving lab informatics, drug discovery, and predictive modeling. By enabling AI-driven simulations to enhance research design, enhance patient safety, and optimize operational efficiency, virtual twin experiences help to further create the future. When combined, these developments improve medical research, speed up discoveries, and enhance decision-making.
Speaker
SAILESH BAJPAI
Solution Consultant, Medidata
a Dassault Systèmes company
12:50 –Networking luncheon
14:00 – Keynote Panel Discussion: Decentralisation - Sustaining DCT adoption in a challenging economic environment. Ensuring best blend of DCT & in-person elements
DECENTRALISATION
- Understanding the Economic Impact on Decentralised Clinical Trials (DCTs): Adapting to cost constraints while maintaining trial efficiency.
- Optimising the Hybrid Model: Balancing decentralised and in-person trial elements for patient-centric and cost-effective solutions.
- Enhancing Patient Accessibility: Leveraging decentralisation to improve participation while minimising economic barriers.
- Technology Integration and Cost Management: Ensuring scalable, cost-efficient platforms to support DCT adoption.
- Regulatory and Operational Challenges: Navigating compliance and logistics in mixed trial models during economic uncertainty.
- Measuring Success: Evaluating outcomes, cost savings, and patient engagement to sustain DCT adoption long-term.
Moderator
VISHWAS SOVANI
Founder Director
Pharmawisdom
Panellists
RAMESH JAGANNATHAN
VP, Medical Dept, Clinical Research & PV
Bharat Serums and Vaccines
VAIBHAV SALVI
Director & Head – Clinical Study Unit, India & South East Asia
Sanofi
JEROZE DALAL
Head of Clinical Operations, Medical Governance & Risk Management
GSK
AMARNATH SUGUMARAN
AssociAte Director & Cluster Head Medical Affairs
Cipla
K. MURUGANANTHAN
Head – Study & Site Operations(SSO India), Global,Clinical Operation(GCO)
Novartis
14:50 - Clinical Trial Supply - What’s the new way forward?
- Current scenario & communication transparency
- Benchmarking success in avoiding common pitfalls & nightmares in clinical trial supply
- Quantifying and mitigating the risk of drug shortages
- Implementing true end-to-end visibility across the supply chain
- Enabling full traceability of clinical trial supplies
- Risk analysis
15:20 – Afternoon Tea/Coffee
15:40 – Clinical Trials – Market Analysis: Opportunities & Challenges
CHALLENGES & OPPORTUNITIES
- The India advantage
- Overview of global clinical trial challenges and myths and current reality of conducting trials in India
- Review the challenges the industry is facing and the impact of clinical trial progression
- Addressing challenges in recruiting diverse patient populations and ensuring long-term retention.
- Balancing trial budgets while maintaining quality, data integrity, and timelines.
- Learn lessons from experience / case studies
Moderator
SAKHARAM GARALE
Founder & CEO
RENOVARE Healthcare
16:10 – DISCUSSION WITH EXPERTS: Outsourcing in Clinical Trials: Crafting Partnerships for Success
OUTSOURCING / PARTNERSHIPS
- Defining Clear Objectives: Establishing shared goals and expectations to align all stakeholders.
- Selecting the Right Partners: Key criteria for evaluating and choosing CROs and other service providers.
- Building Trust and Transparency: Strategies for fostering open communication and mutual confidence.
- Setting Metrics for Success: Establishing performance benchmarks to monitor progress and outcomes.
- Navigating Challenges: Proactive approaches to mitigate risks and resolve conflicts in partnerships.
- Sustaining Long-Term Partnerships: Best practices for evolving and maintaining successful outsourcing relationships.
Moderator
OMPRAKASH S. SADHWANI
Former Joint Commissioner & Controlling Authority
FDA (Maharashtra State)
Panellists
ASHISH GAWDE
Country Medical Director
Bayer
ANUP PINGLE
Medical Director, Global Health Access
GSK
NISHITH VYAS
Senior Global Management Consulting
Novartis
RICHARD LIPSCOMBE
Managing Director
Proteomics International
VIVEK GUPTA
Associate Director
Strategic Engagements & Vendor Management,
Clinical & Medical Affairs, Organon
17:00 - End of conference Day 01
08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues
09:30 – Welcome Address
09:40 – Innovative methods for Clinical trial design
Clinical Trial Inspection
- 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 to wards improving trial success rates?
- Effective trial design and improved compliance
Speaker
Head Medical Affairs,
Alkem Laboratories
10:10 – DISCUSSION WITH EXPERTS: Working together to accelerate trials - SPONSOR – SITE – CRO – PATIENTS - REGULATORS - “Collaborate, Communicate, Accelerate.”
SPONSOR – SITE – CRO – PATIENTS – REGULATORS
- Sponsors and CROs: Building strong partnerships to align goals, share data, and streamline trial processes.
- Sites and Sponsors: Enhancing collaboration to address operational challenges and drive trial efficiency.
- Patients at the Core: Ensuring patient input and experience guide trial designs for better recruitment and retention.
- Regulators and Transparency: Promoting open communication to expedite approvals and maintain compliance.
- Cross-Stakeholder Synergy: Bridging gaps between all players to foster shared accountability and results.
- Leveraging Technology: Enabling real-time data sharing and collaboration across teams and geographies.
Moderator
Founder & Director,
Zantus Lifesciences
Panellists
Associate VP & Head,
Development Center of Excellence Specialty Medicine,
Sun Pharma
Head – Medical, Regulatory, Vigilance & Quality (South Asia),
Fresenius Kabi
MUKESH GORI,
Director ESP Engagement PV & PS,
Novartis
Head Medical Affairs,
GSK
Bharat Serums and Vaccines
11:00 – Morning Coffee/Tea & Discussion
11:30 – DISCUSSION WITH EXPERTS: “Patients First, Always.” - Prioritising patients in trials – Bringing it all together to enhance the patient safety
PATIENT CENTRICITY
- Embedding Patient-Centric Practices: Strategies for integrating patient needs into every stage of clinical trials.
- Enhancing Patient Safety: Key measures to safeguard participants throughout the trial lifecycle.
- Improving Communication: Transparent, empathetic engagement to build trust and ensure informed participation.
- Customising Trial Designs: Adapting protocols to accommodate diverse patient populations and preferences.
- Leveraging Technology: Using digital tools to monitor, support, and ensure patient safety effectively.
Moderator
Founder Director,
Pharmawisdom
Panellists
Country Medical Head,
Novartis
Head Medical Affairs,
Alkem Laboratories
MANISH MAHAJAN,
GM – Lead Medical Affairs BU Biologics,
Zydus Group
Senior GM – Medical Affairs,
Ipca Laboratories
12:20 – From Discovery to Delivery: Harnessing AI, Data Management & Digital Transformation to Optimize Drug Development
In the fast-changing life sciences landscape, Dassault Systèmes is transforming drug development by fusing cutting-edge technology with extensive scientific knowledge, data power, and artificial intelligence. With tools like Clinical Data Studio for smooth data integration and compliance and Simulant for AI-powered trial optimization, Medidata propels clinical innovation. BIOVIA ensures manufacturing quality control while improving lab informatics, drug discovery, and predictive modeling. By enabling AI-driven simulations to enhance research design, enhance patient safety, and optimize operational efficiency, virtual twin experiences help to further create the future. When combined, these developments improve medical research, speed up discoveries, and enhance decision-making.
Speaker
Solution Consultant, Medidata,
a Dassault Systèmes company
12:50 –Networking luncheon
14:00 – Keynote Panel Discussion: Decentralisation - Sustaining DCT adoption in a challenging economic environment. Ensuring best blend of DCT & in-person elements
DECENTRALISATION
- Understanding the Economic Impact on Decentralised Clinical Trials (DCTs): Adapting to cost constraints while maintaining trial efficiency.
- Optimising the Hybrid Model: Balancing decentralised and in-person trial elements for patient-centric and cost-effective solutions.
- Enhancing Patient Accessibility: Leveraging decentralisation to improve participation while minimising economic barriers.
- Technology Integration and Cost Management: Ensuring scalable, cost-efficient platforms to support DCT adoption.
- Regulatory and Operational Challenges: Navigating compliance and logistics in mixed trial models during economic uncertainty.
Moderator
Founder Director,
Pharmawisdom
Panellists
VP, Medical Dept, Clinical Research & PV,
Bharat Serums and Vaccines
Director and Head,
Sanofi
JEROZE DALAL,
Head of Clinical Operations,
Medical Governance & Risk Management,GSK
AssociAte Director & Cluster Head Medical Affairs,
Cipla
Head – Study & Site Operations(SSO India),
Global,Clinical Operation(GCO), Novartis
14:50 - Clinical Trial Supply - What’s the new way forward?
- Current scenario & communication transparency
- Benchmarking success in avoiding common pitfalls & nightmares in clinical trial supply
- Quantifying and mitigating the risk of drug shortages
- Implementing true end-to-end visibility across the supply chain
- Enabling full traceability of clinical trial supplies
15:20 – Afternoon Tea/Coffee
15:40 – Clinical Trials – Market Analysis: Opportunities & Challenges
CHALLENGES & OPPORTUNITIES
- The India advantage
- Overview of global clinical trial challenges and myths and current reality of conducting trials in India
- Review the challenges the industry is facing and the impact of clinical trial progression
- Addressing challenges in recruiting diverse patient populations and ensuring long-term retention.
- Balancing trial budgets while maintaining quality, data integrity, and timelines.
- Learn lessons from experience / case studies
Moderator
Founder & CEO,
RENOVARE Healthcare
16:10 – DISCUSSION WITH EXPERTS: Outsourcing in Clinical Trials: Crafting Partnerships for Success
OUTSOURCING / PARTNERSHIPS
- Defining Clear Objectives: Establishing shared goals and expectations to align all stakeholders.
- Selecting the Right Partners: Key criteria for evaluating and choosing CROs and other service providers.
- Building Trust and Transparency: Strategies for fostering open communication and mutual confidence.
- Setting Metrics for Success: Establishing performance benchmarks to monitor progress and outcomes.
- Navigating Challenges: Proactive approaches to mitigate risks and resolve conflicts in partnerships.
Moderator
CEO, QBD International,
United Nations Adviser
Panellists
ASHISH GAWDE,
Country Medical Director,
Bayer
Medical Director,
Global Health Access, GSK
NISHITH VYAS,
Senior Global Management Consulting,
Novartis
Managing Director,
Proteomics International
Associate Director,
Strategic Engagements & Vendor Management,
Clinical & Medical Affairs, Organon
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 – DISCUSSION WITH EXPERTS: “Transforming Clinical Trials with RWE and RWD: Unlocking Challenges and Opportunities”
RWE / RWD
- Understanding the role of Real-World Evidence (RWE) and Real-World Data (RWD) in modern clinical trials.
- How RWD informs more inclusive and representative trial protocols.
- Leveraging RWD to identify and engage diverse patient populations.
- Overcoming challenges in ensuring accuracy and reliability of real-world data.
- Navigating the evolving landscape of regulatory acceptance for RWE in clinical trials.
- Using RWE to streamline trial processes and reduce costs.
- Exploring the potential of RWE and RWD to drive innovation and shape the future of clinical research.
Moderator
VISHVAJIT M. KARANDIKAR
Business Unit (BU) Head – Parenteral Nutrition
Fresenius Kabi
Panellists
SHALINI MENON
Executive VP Medical Affairs
GSK
MAHENDRA BIJARNIA
Senior Director – Statistics
AstraZeneca
DEVEN BABRE
Director Life Science Centre of Excellence
Fresh Gravity
JAMAL BAIG
Multi Country Safety Head
Sanofi
KAVITA LAMROR
Partner, RWE & Digital Transformation
Maxis Clinical Sciences
10:50 – Morning Coffee/Tea & Discussion
11:20 – DISCUSSION WITH EXPERTS: “Achieving Compliance and Inspection Readiness: The Role of Effective Risk Monitoring”
COMPLIANCE / INSPECTION / RISK MANAGEMENT
- Developing strategies to identify, assess, and mitigate potential risks in clinical trials.
- Tools and techniques to ensure ongoing adherence to regulatory standards and guidelines.
- Best practices for maintaining inspection readiness and ensuring smooth regulatory audits.
- Ensuring staff is well-prepared and knowledgeable about compliance requirements and risk mitigation.
- Addressing the critical role of data accuracy in minimizing compliance risks.
- Strengthening communication and collaboration with regulators to stay ahead of compliance changes.
- Creating a feedback loop to refine risk management processes and adapt to evolving regulatory expectations.
Moderator
VIPIN SETHI
Vice President
Cadila
Panellists
SAKSHI SHRIVASTAVA DESAI
Director, LMS regional Lead APAC
Johnson & Johnson
SOURABH FULMALI
Global Medical Director
GSK
ANUJA JAWALE
Associate Director – R&D Procurement & Supplier Management
Organon
ASHWANI PANDITA,
Sr. GM Quality Management & Training
Global Clinical Research Operations, Glenmark Pharmaceuticals
NEELAKANT KRISHNAN
Sr. GM – Head Global Trial Management
Sun Pharma
SHILPA HARIHAR RAUT
Associate Director – Clinical Operations
Tech Observer
12:10 – Decentralized Trials - Keeping the patients first
SHILPA HARIHAR RAUT
Associate Director – Clinical Operations
Tech Observer
12:40 –Networking luncheon
13:50 – Keynote Panel Discussion: “Technology & Innovation: Transforming clinical trials – Challenges and Opportunities”
IMPACT OF TECHNOLOGY
- How digital tools are creating more flexible and efficient clinical trial designs.
- Exploring the benefits and challenges of conducting trials beyond traditional settings.
- The role of big data and AI in improving trial efficiency and decision-making.
- Using technology to enhance participant engagement, diversity, and retention rates.
- Addressing challenges related to the accuracy and protection of trial data in digital environments.
- Navigating the evolving regulatory landscape for technology-driven trials.
- Emerging innovations and their potential to reshape the clinical trial process for the better.
Moderator
MANGALA KOTNIS
Former Head Regional Medical Affairs
Abbott
Panellists
GOPINATH MADHU
Senior Client Partner, Digital & Technology
Pfizer
RASHMI HEGDE
Former Executive VP – Medical
GSK
VINAYKUMAR NANDIMATH
Head Global Clinical Monitoring
Dr. Reddy’s Biologics
KUSHAL SARDA
GM & Head – Medical Affairs, Clinical Research & PV
Shalina Healthcare
RUPESH NEHRA
Senior Manager – Data Science
Pfizer
14:40 – Agile ways of Project Management - Transforming delivery of clinical trials
- Adapting Agile Project Management in the oversight of clinical trial delivery brings efficiency, removing bottlenecks early enough and improves collaboration between teams
- Planning and reviewing the plan in sprints help the teams to move forward by brining focused attention to the tasks
- Visual representation of the progress helps bring accountablity
- Creating growth mindset to enhance the delivery of clinical trials
Speaker
PRIYA RAJAGOPAL
Director Study Delivery, Vx GCD, GCO
GSK
15:10 – Afternoon Tea/Coffee
15: 30 – 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
RENUKA NEOGI
Head & Deputy GM – Global Clinical Quality Management
Sun Pharma
16:00 – Keynote Panel Discussion: “Advancing Clinical Trials in India: Key Regulatory Changes & Developments – What’s the way forward?”
REGULATORY
- How regulatory reforms can shorten approval timelines and facilitate faster trial initiation.
- Strengthening ethical frameworks to ensure patient safety while promoting trial innovation.
- Addressing bureaucratic hurdles and improving transparency in trial submissions.
- Regulations to foster international collaboration and attract global sponsors to Indian trials.
- Aligning with global data protection practices to build trust in clinical trials.
- Regulatory flexibility to support the adoption of innovative trial designs and technologies.
- Enhancing dialogue between stakeholders to ensure regulatory frameworks meet industry needs while prioritizing patient safety.
Moderator
MILIND ANTANI
Leader, Pharma & Healthcare
Nishith Desai Associates
Panellists
NIVEDITA TELANG,
Medical & Regulatory Director
Sanofi
HARSHAD KOTHAWADE
Former Head of Regulatory Management & Trade Compliance
Merck Group
AMIT PANDEY
Executive Vice President & General Counsel
GlaxoSmithKline Pharmaceuticals
MARTINA GOMES
Head, Reg Affairs – CH
Bayer
APARNA PRABHUNE
Deputy General Manager – Regulatory Affairs
Wockhardt
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
Director – Development Quality Assurance,
Cipla
10:00 – DISCUSSION WITH EXPERTS: “Transforming Clinical Trials with RWE and RWD: Unlocking Challenges and Opportunities
RWE / RWD
- Understanding the role of Real-World Evidence (RWE) and Real-World Data (RWD) in modern clinical trials.
- How RWD informs more inclusive and representative trial protocols.
- Leveraging RWD to identify and engage diverse patient populations.
- Overcoming challenges in ensuring accuracy and reliability of real-world data.
- Navigating the evolving landscape of regulatory acceptance for RWE in clinical trials.
- Using RWE to streamline trial processes and reduce costs.
- Exploring the potential of RWE and RWD to drive innovation and shape the future of clinical research.
Moderator
Business Unit (BU) Head – Parenteral Nutrition,
Fresenius Kabi
Panellists
Executive VP Medical Affairs,
GSK
Senior Director – Statistics,
AstraZeneca
Director – Clinical Data Standards & Automation,
Novartis
Multi Country Safety Head,
Sanofi
Partner, RWE & Digital Transformation,
Maxis Clinical Sciences
10:50 – Morning Coffee/Tea & Discussion
11:20 – DISCUSSION WITH EXPERTS: “Achieving Compliance and Inspection Readiness: The Role of Effective Risk Monitoring”
COMPLIANCE / INSPECTION / RISK MANAGEMENT
- Developing strategies to identify, assess, and mitigate potential risks in clinical trials.
- Tools and techniques to ensure ongoing adherence to regulatory standards and guidelines.
- Best practices for maintaining inspection readiness and ensuring smooth regulatory audits.
- Ensuring staff is well-prepared and knowledgeable about compliance requirements and risk mitigation.
- Addressing the critical role of data accuracy in minimizing compliance risks.
- Strengthening communication and collaboration with regulators to stay ahead of compliance changes.
Moderator
Vice President,
Cadila
Panellists
Director, LMS regional Lead APAC,
Johnson & Johnson
Global Medical Director,
GSK
Associate Director – R&D Procurement & Supplier Management,
Organon
Sr. GM Quality Management & Training,
Global Clinical Research Operations, Glenmark Pharmaceuticals
Sr. GM – Head Global Trial Management,
Sun Pharma
12:10 – Planning and executing Medical device (Class II, III) clinical studies
- Clinical strategy and successful execution for market launch, submission, evidence generation etc.
- Validated techniques to build robust clinical evidence
- Clinical development pathways across India, US and Global markets
Speaker
Associate Director – Clinical Operations,
Tech Observer
12:40 –Networking luncheon
13:50 – Keynote Panel Discussion: “Technology & Innovation: Transforming clinical trials – Challenges and Opportunities”
IMPACT OF TECHNOLOGY
- How digital tools are creating more flexible and efficient clinical trial designs.
- Exploring the benefits and challenges of conducting trials beyond traditional settings.
- The role of big data and AI in improving trial efficiency and decision-making.
- Using technology to enhance participant engagement, diversity, and retention rates.
- Addressing challenges related to the accuracy and protection of trial data in digital environments.
- Navigating the evolving regulatory landscape for technology-driven trials.
Moderator
Former Head Regional Medical Affairs,
Abbott
Panellists
Director – Medical Affairs,
Johnson & Johnson
Asst. Vice President,
Biologics NCE Vaccines – Amneal Group
Senior Client Partner,
Digital & Technology, Pfizer
Former Executive VP – Medical,
GSK
GM & Head ‑ Digital (Pharma),
Shalina Healthcare
Senior Manager – Data Science,
Pfizer
14:40 – Agile ways of Project Management - Transforming delivery of clinical trials
- Adapting Agile Project Management in the oversight of clinical trial delivery brings efficiency, removing bottlenecks early enough and improves collaboration between teams
- Planning and reviewing the plan in sprints help the teams to move forward by brining focused attention to the tasks
- Visual representation of the progress helps bring accountablity
Moderator
Director Study Delivery,
Vx GCD, GCO, GSK
15:10 – Afternoon Tea/Coffee
15: 30 – 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
Moderator
Head & Deputy GM – Global Clinical Quality Management,
Sun Pharma
16:00 – Keynote Panel Discussion: “Advancing Clinical Trials in India: Key Regulatory Changes & Developments – What’s the way forward?”
REGULATORY
- How regulatory reforms can shorten approval timelines and facilitate faster trial initiation.
- Strengthening ethical frameworks to ensure patient safety while promoting trial innovation.
- Addressing bureaucratic hurdles and improving transparency in trial submissions.
- Regulations to foster international collaboration and attract global sponsors to Indian trials.
- Aligning with global data protection practices to build trust in clinical trials.
- Regulatory flexibility to support the adoption of innovative trial designs and technologies.
- Enhancing dialogue between stakeholders to ensure regulatory frameworks meet industry needs while prioritizing patient safety.
Moderator
Leader, Pharma & Healthcare,
Nishith Desai Associates
Panellists
Drugs Inspector (Deputy Collector, Gujarat Government),
FDA
Director Government and Public Affairs,
Boehringer Ingelheim
Medical & Regulatory Director,
Sanofi
Former Head of Regulatory Management & Trade Compliance,
Merck Group
Head, Reg Affairs – CH,
Bayer
17:00 – Closing remarks and End of conference
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Event Testimonials
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Pricing Details
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STANDARD PRICE — INR 19,000 + GST (18%) PER DELEGATE
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
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Venue details
The venue is easily accessible, well-equipped with modern amenities, and offers a comfortable, professional setting for all attendees.
Venue
Hotel Kohinoor
Continental
Andheri Kurla Road, Andheri (E)
Mumbai – 400059,
India
+91 22 6769 3500
Venue – Hotel Kohinoor Continental
Andheri Kurla Road, Andheri ( E ),
Mumbai – 400059
Maharashtra, India
+91 22 6769 3500
