UTTAM C
19th August 7th Annual Pharma Packaging Labelling Serialization and Supplychain 2025
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
19th August 7th Annual Pharma Packaging Labelling Serialization and Supplychain 2025
09:20 – Welcome address and opening remarks
19th August 7th Annual Pharma Packaging Labelling Serialization and Supplychain 2025
PACKAGING
09:30 – Driving Packaging Excellence in Pharma: A Strategic Shift from Function to Future
• Leveraging smart and connected packaging to enhance patient-centric outcomes
• Balancing sustainability with functionality: Navigating regulatory and material challenges
• Role of automation and AI in optimizing packaging workflows and compliance
• Global packaging harmonization – a roadmap to operational efficiency and speed to market
SHRINIWAS SINGH, HOD Packaging Development, Themis Medicare
19th August 7th Annual Pharma Packaging Labelling Serialization and Supplychain 2025
SERIALIZATION, TRACK & TRACE
10:00 – DISCUSSION WITH EXPERTS: Pharma Serialization and Track & Trace: Ensuring Supply Chain Integrity and Patient Safety
• Track-and-trace in improving visibility and accountability across the pharmaceutical supplychain
• Recent updates over serialization safeguarding against counterfeit medicines to enhance patient safety
• Challenges and opportunities in aligning serialization standards across different regions
• Key hurdles in implementing serialization and track-and-trace solutions and how to overcome them
• Importance of accurate data capture, management and sharing for effective serialization systems
• Harnessing generative AI, block chain and SCOR frameworks to tackle modern challenges
• Integrating anti-tampering and serialization technologies to ensure product authenticity and patient safety.
Moderator
CHAKRAVARTHI AVPS, Global Ambassador, World Packaging Organisation
Panellists
R. M. BAJAJ, Assistant Commissioner, FDA
LOKESH PATEL, Founder Director, URL Aseptic Automation
JOSE CAMARA SANTIAGO, Chief Executive Officer, Camara Validation & Consulting Services
VAIBHAV SALVI, Director & Head - Clinical Study Unit, India & South East Asia, Sanofi
RAJENDRA KUMAR KASI, VP & Global Head – PV, Glenmark
BIJOY PETER, General Manager - Technical Services, GS1
19th August 7th Annual Pharma Packaging Labelling Serialization and Supplychain 2025
10:50 – Morning Tea/Coffee & Networking
19th August 7th Annual Pharma Packaging Labelling Serialization and Supplychain 2025
PACKAGING, LABELLING
11:20 – DISCUSSION WITH EXPERTS: Panel discussion with experts: Driving innovation and sustainability in pharma packaging: Trends, challenges and opportunities
• Exploring advancements in smart packaging, connected solutions and patient-centric designs.
• Impacts of outsourcing to manufactures, consumers and other stakeholders.
• Will outsourcing packaging to contract packaging industries paves way for core companies to stay focus in R&D.
• Addressing eco-friendly materials, circular economy strategies and reducing packaging waste.
• Advance labeling technologies: Ensuring accuracy, compliance and readability
• Leveraging AI, automation and new technologies to redefine the packaging landscape.
• Designing packaging that improves adherence, accessibility and overall user experience
Moderator
OMPRAKASH S. SADWANI, Former Joint Commissioner & Controlling Authority, FDA (Maharashtra State)
Panellists
AMIT KALE, Associate Vice President, Reliance Retail
B. G. BARVE, Joint Managing Director, Blue Cross Laboratories
PRAFULL V. DESHPANDE, Team Lead- R&D Pkg. Development, Lupin
BHUPESH MITTAL, Technical Packaging Program Lead, Bayer
ASHOK KUMAR BHATTACHARYA, Former Executive Director, Takeda
19th August 7th Annual Pharma Packaging Labelling Serialization and Supplychain 2025
12:10 – Barcoding Technology - Game changer in consumer behaviour
LOKESH PATEL, Founder Director, URL Aseptic Automation
19th August 7th Annual Pharma Packaging Labelling Serialization and Supplychain 2025
12:40 - Networking luncheon
19th August 7th Annual Pharma Packaging Labelling Serialization and Supplychain 2025
SUPPLY CHAIN
13:40 – DISCUSSION WITH EXPERTS: Building agile and secure pharma supply chains: Adapting to global challenges and future opportunities
• Transforming pharma supply chains: Driving efficiency, resilience and patient-centric solutions
• Building agile and robust supply chains to mitigate disruptions and ensure continuity
• Adapting supply chain strategies to meet evolving patient needs and expectations
• Innovations and best practices for maintaining the integrity of temperature-sensitive pharmaceuticals
• Identifying vulnerabilities and implementing proactive measures to address potential risks
• Fostering partnerships across stakeholders to optimize supply chain operations
• Insights into emerging trends such as AI, block chain and predictive analytics shaping the pharma supply chain
Moderator
PRASAD SHIDHAYE, Ex-Director, India, Deliver Asia Pacific, Supply Chain, Johnson & Johnson
Panellists
ASHU GUPTA, Vice President, Supply Chain, Koye Pharmaceuticals
SUDIPTO BASU, VP - Head of SCM, Procurement & Packaging, Virbac
TEJAS MEHTA, Assistant VP Head Logistics & MSS, Reliance Life Sciences
GRESH KUMAR, Global Operations Excellence Director, Novartis
GIRIJESH SRIVASTAVA, Global Supply Chain Manager, Sun Pharma
19th August 7th Annual Pharma Packaging Labelling Serialization and Supplychain 2025
LABELLING
14:30 – Future of pharmaceutical labelling: enhancing patient safety and engagement through digital innovation and regulatory compliance
• Overview of product information on labelling enables patient safety.
• Describe the effective utilization of digital patient labelling.
• Will QR codes eliminate the need of physical inserts.
• Is Health Literacy only a public concern.
• How language service providers enable penetration of product information on labelling.
• How AR and QR enables dynamic instruction via smartphone.
• Intricacies of regulatory compliance in clinical trial labelling.
• Looking ahead, the integration of AI and ML in smart label system.
19th August 7th Annual Pharma Packaging Labelling Serialization and Supplychain 2025
15:00 – Afternoon Tea/Coffee
19th August 7th Annual Pharma Packaging Labelling Serialization and Supplychain 2025
15:30 – Serialization as a pillar of pharmaceutical safety: Combating counterfeiting and ensuring product quality
• How GS1 organisation plays a role in serialisation.
• Serialization are pivotal thing to prevent the entry of fake drugs and counterfeiting
• Its ability to produce tailored information about product quality helps in withdrawing defective drugs
• Impact of serialization in supply chain management
• Serialization in the prevention of unauthorized drugs into the market and safeguarding public health.
• Planning for 2028: How can the suppliers be prepared for authenticity on delivered products?
SOMNATH BASU, Team Leader of Reviewers of Drugs, National Regulatory Authority for Drugs
19th August 7th Annual Pharma Packaging Labelling Serialization and Supplychain 2025
REGULATORY
16:00 – DISCUSSION WITH EXPERTS: Navigating the Pharma Regulatory Maze: Compliance Strategies for Packaging, Labeling, Serialization and Track & Trace
• An overview of packaging, labeling, serialization and track-and-trace regulations across key markets
• Addressing common hurdles in meeting diverse and evolving regulatory requirements
• Insights into GS1 standards and their application for global compliance.
• Adapting to region-specific track-and-trace guidelines such as DSCSA (US) and EU FMD
• Navigating the complexities of regulatory reporting and audit readiness
• Adapting to regulatory evolution: Balancing operational efficiency and stakeholder collaboration
• Managing compliance across international borders and harmonizing operations
Moderator
VISHWAS SOVANI, Director, Pharma Wisdom
Panellists
TRIPTI NAKHARE, Associate VP Regulatory Affairs & Packaging Development, FDC Limited
VENKATESH KATGERI, Vice President, Site Head, Srikem Laboratories
MINOO BIJU, Head-Regulatory Affairs, Piramal Pharma Solutions
HARSHAD KOTHAWADE, Former Head of Regulatory Management & Trade Compliance, Merck Group
SONIKA SHARMA SHAH, General Manager Regulatory Affairs, GSK
19th August 7th Annual Pharma Packaging Labelling Serialization and Supplychain 2025
16:50 - Closing remarks and end of conference
12th June 16th Annual Clinical Trials Summit 2025 – Day 2
08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues.
12th June 16th Annual Clinical Trials Summit 2025 – Day 2
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.
DIVAKAR KOLLI, Director - Development Quality Assurance, Cipla
12th June 16th Annual Clinical Trials Summit 2025 – Day 2
RWE / RWD
10:00 – DISCUSSION WITH EXPERTS: “Transforming Clinical Trials with RWE and RWD: Unlocking Challenges and Opportunities
• 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
Panelists
SHALINI MENON, Executive VP Medical Affairs, GSK
MAHENDRA BIJARNIA, Senior Director – Statistics, AstraZeneca
TUSHAR SAKPAL, Director - Clinical Data Standards & Automation, Novartis
JAMAL BAIG, Multi Country Safety Head, Sanofi
KAVITA LAMROR, Partner, RWE & Digital Transformation, Maxis Clinical Sciences
12th June 16th Annual Clinical Trials Summit 2025 – Day 2
10:50 – Morning Coffee/Tea & Discussion
12th June 16th Annual Clinical Trials Summit 2025 – Day 2
COMPLIANCE / INSPECTION / RISK MANAGEMENT
11:20 – DISCUSSION WITH EXPERTS: “Achieving Compliance and Inspection Readiness: The Role of Effective Risk Monitoring”
• 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
Panelists
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
12th June 16th Annual Clinical Trials Summit 2025 – Day 2
12:10 – Decentralized Trials - Keeping the patients first
SHILPA HARIHAR RAUT, Associate Director - Clinical Operations, Tech Observer
12th June 16th Annual Clinical Trials Summit 2025 – Day 2
12:40 –Networking luncheon
12th June 16th Annual Clinical Trials Summit 2025 – Day 2
IMPACT OF TECHNOLOGY
13:50 – Keynote Panel Discussion: “Technology & Innovation: Transforming clinical trials – Challenges and Opportunities”
• 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
Panelists
SRIRUPA DAS, Director - Medical Affairs, Johnson & Johnson
UDAY HARLE, Asst. Vice President, Biologics NCE Vaccines - Amneal Group
GOPINATH MADHU, Senior Client Partner, Digital & Technology, Pfizer
RASHMI HEGDE, Former Executive VP – Medical, GSK
VAIBHAV AGARWAL, GM & Head ‑ Digital (Pharma), Shalina Healthcare
RUPESH NEHRA, Senior Manager - Data Science, Pfizer
12th June 16th Annual Clinical Trials Summit 2025 – Day 2
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
PRIYA RAJAGOPAL, Director Study Delivery, Vx GCD, GCO, GSK
12th June 16th Annual Clinical Trials Summit 2025 – Day 2
15:10 – Afternoon Tea/Coffee
12th June 16th Annual Clinical Trials Summit 2025 – Day 2
SITE MANAGEMENT
15: 30 – Creating an effective clinical trial 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
RENUKA NEOGI, Head & Deputy GM – Global Clinical Quality Management, Sun Pharma
12th June 16th Annual Clinical Trials Summit 2025 – Day 2
REGULATORY
16:00 – Keynote Panel Discussion: “Advancing Clinical Trials in India: Key Regulatory Changes & Developments – What’s the way forward?”
• 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
Panelists
MAYUR PARMAR, Drugs Inspector (Deputy Collector, Gujarat Government), FDA
NIVEDITA TELANG, Medical & Regulatory Director, Sanofi
HARSHAD KOTHAWADE, Former Head of Regulatory Management & Trade Compliance, Merck Group
MARTINA GOMES, Head, Reg Affairs – CH, Bayer
APARNA PRABHUNE, Deputy General Manager – Regulatory Affairs, Wockhardt
12th June 16th Annual Clinical Trials Summit 2025 – Day 2
17:00 – Closing remarks and End of conference
11th June 16th Annual Clinical Trials Summit 2025 – Day 1
08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues
11th June 16th Annual Clinical Trials Summit 2025 – Day 1
09:30 – Welcome Address
11th June 16th Annual Clinical Trials Summit 2025 – Day 1
CLINICAL TRIAL DESIGN
09:40 – 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 to wards improving trial success rates?
• Effective trial design and improved compliance
ROSHAN PAWAR, Head Medical Affairs, Alkem Laboratories
11th June 16th Annual Clinical Trials Summit 2025 – Day 1
SPONSOR – SITE – CRO – PATIENTS - REGULATORS
10:10 – DISCUSSION WITH EXPERTS: Working together to accelerate trials - SPONSOR – SITE – CRO – PATIENTS - REGULATORS - “Collaborate, Communicate, Accelerate.”
• 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
Panelists
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 Global Patient Safety, Amgen
KRUNAL DALAL, Head Medical Affairs, GSK
PRASHANT MEHROTRA, Senior GM - Clinical Research, Bharat Serums and Vaccines
11th June 16th Annual Clinical Trials Summit 2025 – Day 1
11:00 – Morning Coffee/Tea & Discussion
11th June 16th Annual Clinical Trials Summit 2025 – Day 1
PATIENT CENTRICITY
11:30 – DISCUSSION WITH EXPERTS: “Patients First, Always.” - Prioritising patients in trials – Bringing it all together to enhance the patient safety
• 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
Panelists
RISHI JAIN, Country Medical Head, Novartis
MAYUR MAYBHATE, Head Medical Affairs, Alkem Laboratories
MANISH MAHAJAN, GM - Lead Medical Affairs BU Biologics, Zydus Group
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
11th June 16th Annual Clinical Trials Summit 2025 – Day 1
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.
SAILESH BAJPAI, Solution Consultant, Medidata, a Dassault Systèmes company
11th June 16th Annual Clinical Trials Summit 2025 – Day 1
12:50 –Networking luncheon
11th June 16th Annual Clinical Trials Summit 2025 – Day 1
DECENTRALISATION
14:00 – Keynote Panel Discussion: Decentralisation - Sustaining DCT adoption in a challenging economic environment. Ensuring best blend of DCT & in-person elements
• 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
Panelists
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
11th June 16th Annual Clinical Trials Summit 2025 – Day 1
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
11th June 16th Annual Clinical Trials Summit 2025 – Day 1
15:20 – Afternoon Tea/Coffee
11th June 16th Annual Clinical Trials Summit 2025 – Day 1
CHALLENGES & OPPORTUNITIES
15:40 – Clinical Trials – Market Analysis: Opportunities & Challenges
• 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
SAKHARAM GARALE, Founder & CEO, RENOVARE Healthcare
11th June 16th Annual Clinical Trials Summit 2025 – Day 1
OUTSOURCING / PARTNERSHIPS
16:10 – DISCUSSION WITH EXPERTS: Outsourcing in Clinical Trials: Crafting Partnerships for Success
• 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
RANJIT BARSHIKAR, CEO, QBD International, United Nations Adviser
Panelists
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
11th June 16th Annual Clinical Trials Summit 2025 – Day 1
17:00 - End of conference Day 01
11th March 8th Annual Pharma Regulatory 2025
08:30 – Coffee and Registration – An opportunity to meet and network with your conference colleagues.
11th March 8th Annual Pharma Regulatory 2025
09:20 – Welcome Address & Opening remarks
11th March 8th Annual Pharma Regulatory 2025
RWE / RWD
09:30 – Harvesting & Using RWE – Public, Private Partnerships to Bridge to Regulatory Requirements
• Perfect methods of collecting, storing and analysing RWE
• How do you ensure data is sufficient and support submission messaging?
• Can we expect further integration of this type of data into submissions?
• How can teams pivot to meet the demands of RWE and related submission changes?
• Enhance data integrity - utilizing digital solutions to ensure that data across systems and documents is consistent, reliable, and ready for regulatory scrutiny.
• The future of RWD RWE digital era
NEERAJ MARKANDEYWAR, General Manager - Medical Affairs, Sun Pharma
11th March 8th Annual Pharma Regulatory 2025
DIGITAL ERA
10:00 – KEYNOTE TECH PANEL DISCUSSION - The Impact of Digitalization in Pharmaceutical Regulatory Affairs
• How AI technologies are reshaping the landscape of compliance, risk management, and regulatory processes?
• How industry expertise combined with advanced technologies, can enhance the reliability and trust (transparency, completeness, correctness, and timeliness).
• Leveraging Technology in Clinical Research and Regulatory Affairs
• Adopting to technological side for enhancing patient safety in recognizing early warning symptoms using advanced devices
• Navigate digital transformation challenges - Strategies for successfully implementing computer assisted assessments in the regulatory processes, including global regulatory impact assessment.
• Adding Value to Regulatory Operations with GenAI
• Regulatory Innovation with AI: Balancing Progress and Compliance
Moderator
RASHMI HEGDE, Former Executive VP – Medical, GSK
Panellists
RAMANARAYANA PARHI, Vice President & CIO, Alkem Laboratories
NIVEDITA TELANG, Medical & Regulatory Director, Sanofi
SRINIVASAN ACHARY, Associate Director, Cipla
AMOL DESHPANDE, DGM Technology Transfer, Emcure Pharmaceuticals
GOPINATH MADHU, Senior Client Partner, Digital & Technology, Pfizer
11th March 8th Annual Pharma Regulatory 2025
10:50 – Morning Coffee/Tea & Discussion
11th March 8th Annual Pharma Regulatory 2025
MEDICAL DEVICES
11:20 – DISCUSSION WITH EXPERTS: Accessing the Indian Market – Current and Upcoming State of the Indian Medical Device Regulation
• How organized can the approval of medical devices be? – Unfolding the complicated and time-intensive process which is simultaneously resource-consuming
• Which pain points would industry like to see resolved?
• Perspective from Pharmaceutical Stakeholders
• Share evolving global, regional and country regulatory trends for medical devices
• How to proactively update your quality management system with evolving regulatory requirements
• With MDSW and AI/ML changing rapidly, what can we expect in the next 5 years for regulating these types of devices and diagnostics?
• Manufacturing of domestic devices rather than depending on importing - Bearing in mind the differences between other nations' regulations
• Regulatory streamlines and appealing expenditures considerations in the manufacturing of prospering medical devices
Moderator
OMPRAKASH S. SADHWANI, Former Joint Commissioner & Controlling Authority, FDA (Maharashtra State)
Panellists
SAILESH YHNB, Associate Director, RA Device Established Products, Novo Nordisk
VRUSHALI KHANDAGALE, Sr. Executive Regulatory Affairs, Fresenius Kabi
RUCHIR SHAH, Head Medical Devices Category, Regulatory & Safety Manager, Reckitt Benckiser
MANGALA KOTNIS, Former Head Regional Medical Affairs (MSL/ FME function), Abbott
11th March 8th Annual Pharma Regulatory 2025
12:10 – Post Approval Changes: Frequent API Changes leading to DP Post approval changes - A complete overview for global markets
VANDANA SINGH, Head - API Regulatory Sciences, Biocon
11th March 8th Annual Pharma Regulatory 2025
12:40 - Networking luncheon
11th March 8th Annual Pharma Regulatory 2025
REGULATING PHARMA
13:40 – KEYNOTE PANEL DISCUSSION: Looking ahead to the future for new drugs:Regulating Pharmaceuticals in India to prioritise patient safety
• How well are we doing with recent legislations?
• With legislative reforms on the horizon, how does the future look for pharmaceuticals in India?
• Expectations from industry / Cross-regional harmonisation
• New challenges and considerations for regulators and the regulated entities
• Which skills and tools do we expect to become more prevalent in the coming years?
• Can industry and regulators alike prepare for these changes now?
• Regulator’s Challenges in the Digital Era
• Reduce Regulatory Complexity and accelerate patient access
• Towards Instantaneous Approvals in 5 years: What would it take to get there?
Moderator
MILIND ANTANI, Leader, Pharma & Healthcare, Nishith Desai Associates
Panellists
MAYUR PARMAR, Drugs Inspector (Deputy Collector, Gujarat Government), FDA
GURPREET SINGH, VP, Managing Director Integrated Safety, IQVIA
AMIT PANDEY, Executive Vice President & General Counsel, GSK
GEETA SHANBHAG, VP - Pharmacovigilance & Medico-regulatory Affairs, Ipca Laboratories
RAM BALANI, CEO / Founder, eSTARHelper (USA)
ROHINI PANDEY, Regional PV Head – SEA, Abbott
KRUPA BAHEKAR, General Manager, Emcure Pharmaceuticals
11th March 8th Annual Pharma Regulatory 2025
BIOSIMILARS
14:30 - Global Regulatory Landscape of Biological molecules
• Introduction to Biological and Small molecules
• Overview of Regulatory framework for Novel/Biosimilar/generic molecule development
• Regulatory requirements and interchangeability
• Robust CMC package
SWEETY MATHEW, Regulatory Professional, RA CMC Biotech & Rare Disease, Novo Nordisk
11th March 8th Annual Pharma Regulatory 2025
15:00 – Afternoon Tea/Coffee
11th March 8th Annual Pharma Regulatory 2025
CLINICAL TRIALS
15:20 – DISCUSSION WITH EXPERTS: Unlock the secrets to mastering Clinical Trial Regulations - Mystery Un-Corded.
• Clinical Trials - Regulatory Progress
• DCTs: Opportunities and Challenges
• PV in clinical trials and probing
• Clinical Trials – From the standpoint of regulatory submissions
• Remote trials – approaching strategies concurring with reality
• Clinical investigation under regulatory circumstances
• Where are we heading and the way forward?
Moderator
PRASHANT BODHE, Director, CliniSearch
Panellists
YASMIN SHENOY, Senior Director - Regulatory Affairs, Sanofi
RISHI JAIN, Country Medical Head, Novartis
SOURABH FULMALI, Global Medical Director, GSK
AMARNATH SUGUMARAN, Associate Director & Cluster Head Medical Affairs, Cipla
ROSHAN PAWAR, Head Medical Affairs, Alkem Laboratories
11th March 8th Annual Pharma Regulatory 2025
AUDITS / INSPECTIONS / REGULATORY SUBMISSIONS
16:10 – DISCUSSION WITH EXPERTS: Audits & Inspection - Regulatory Submissions, Information & Document Management
• Latest trends, innovations, and best practices
• Accelerating your regulatory submissions
• Importance of communicating effectively with your decision-makers regarding strategy and resource requirements
• Common pain points surrounding regulatory submissions and solutions
• Strategic Innovation in Regulatory: Advancing Technology and Its Impact on Submissions
• Quality audits – critical observance and current developing scenario in documentation
• Proactive approach for Regulatory Compliance
• Regulatory Intelligence as a strategic partner for Regulatory submissions
• FDA – warning letters, approvals, and advancements in regulatory inspections
Moderator
VARSHA NARAYANAN, Founder-Director, Dr Varsha’s Health Solutions
Panellists
ANAND SAXENA, Director - Regulatory Affairs, Cipla
SHIRAZ KANDAWALLA, Head Regulatory, Quality and Safety - India, Ferring Pharma
PRIYESH MISTRY, Head - QA/21CFR Compliance, Intas Pharmaceuticals
SAKHARAM GARALE, Founder & CEO, Renovare Healthcare
11th March 8th Annual Pharma Regulatory 2025
17:00 - Closing remarks and end of conference
11th December 19th Annual Biosimilars Congregation 2024
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
11th December 19th Annual Biosimilars Congregation 2024
CLINICAL DEVELOPMENT
09:30 – Keynote Address - Clinical development issues with Biosimilar development & update
SHUBHADEEP DEBABRATA SINHA, Senior VP, Head - Clinical Development & Medical Affairs, Hetero Labs
11th December 19th Annual Biosimilars Congregation 2024
TRENDS & STRATERGIES
10:00 – KEYNOTE PANEL DISCUSSION: Current trends and strategies to access biosimilar market
• Critical aspects of the global Biosimilar market such as vendor landscape, competitive strategies, market drivers and challenges
• Changing market dynamics within the Biosimilars market
• Innovative clinical approach in biosimilars & Clinical development of biosimilars
• Emerging new ventures who are creating an impact on the global market with their latest innovations an technologies.
• Examining potential barriers to formulary inclusion and reimbursement, including payer preferences and rebate structures
• Current challenges in developing Biosimilars
• Factors that drive the selection of a biosimilar asset
• Identify how biosimilars have improved health equity and access to treatment for patients?
• What makes manufacturers to decide ultimately to bring or not a biosimilar to the market?
Moderator
RANJIT BARSHIKAR, CEO, QBD International, United Nations Adviser
Panellists
ROSHAN PAWAR, Head Medical Affairs, Alkem Laboratories
SAKHARAM GARALE, Founder & CEO, Renovare Healthcare
SAMIR KULKARNI, Head - DBT ICT Center, Institute Of Chemical Technology
UMA SINHA DATTA, Director PDS India, Cytiva
11th December 19th Annual Biosimilars Congregation 2024
11:00 – Morning Coffee / Tea & Discussion
11th December 19th Annual Biosimilars Congregation 2024
11:30 – Advanced Analytical Techniques in Biopharmaceutical Development
• Drug Development Phases: Focus on stages from late discovery to scale-up and the role of analytical characterization in selection and formulation
• Microcalorimetry Techniques: Introduce isothermal and differential scanning calorimetry for measuring heat changes and assessing binding affinity and stability
• Key Factors in Drug Development: Address factors like affinity, efficacy, stability, quality, safety, and cost, and how heat flow techniques help ensure stability
• Real-World Applications: Share examples of using calorimetry to optimize formulations for proteins and antibody-drug conjugates
• Emerging Technologies: Highlight innovations like RS-DSC for high-throughput calorimetry and their potential to improve drug development
SRIJITH EDAKKANNAM, Account Manager Sales, Waters|TA Instruments
11th December 19th Annual Biosimilars Congregation 2024
12:00 – Pharmacovigilance for biosimilars: differences and similarities
• Unique product safety challenges due to the complex nature of biosimilars
• Biosimilars need for comprehensive monitoring of their safety profiles.
• Ensuring safety of biosimilars in terms of potential for immunogenicity, complex adverse drug reactions and signals that can emerge differently in biosimilars despite unknown in originators.
• Hence the need of effective traceability systems, close collaboration among stakeholders, standardized reporting frameworks, and ongoing vigilance to ensure the continued safety and confidence in biosimilars. How do achieve this in PV process and some case studies.
SHRADDHA BHANGE, Senior Medical Safety Lead, Sandoz
11th December 19th Annual Biosimilars Congregation 2024
12:30 – Networking luncheon
11th December 19th Annual Biosimilars Congregation 2024
REGULATORY
13:30 – KEYNOTE PANEL DISCUSSION: Regulatory - The evolving regulatory framework for biosimilar approvals
• Regulatory Updates on Biosimilars
• Adapting to regulatory shifts in approval pathways and staying ahead of induced infringement
• Regulatory factors that go into determining a pathway to biosimilar development
• Prepare and adjust product development plans in light of the evolving regulatory landscape
• Regulatory environment for biosimilar and interchangeable development and licensure
• Interchangeability and switching biosimilar: Regulator’s view
• Significance of multiple forces - regulatory, political, and commercial
• What’s next? Ways to proceed forward
Moderator
MILIND ANTANI, Leader, Pharma and Healthcare, Nishith Desai Associates
Panellists
KRUNAL DALAL, Head Medical Affairs, GSK
KHOKAN DEBNATH, Sr GM / (Head) – Regulatory Affairs, Clinical Operations, PV, QA & Compliance (India & Emerging Market), Wockhardt
SWEETY MATHEW, Regulatory Professional- Global Regulatory Affairs: CMC Rare Diseases, Novo Nordisk
SHRADDHA BHANGE, Senior Medical Safety Lead, Sandoz
MANGALA KOTNIS, Former Head Regional Medical Affairs , Abbott
11th December 19th Annual Biosimilars Congregation 2024
14:30 – Navigating through the regulatory complexities of biological molecules
• Complexity of biological molecules
• Regulatory framework for development of biological molecules
• Robust CMC package
SWEETY MATHEW, Regulatory Professional- Global Regulatory Affairs: CMC Rare Diseases, Novo Nordisk
11th December 19th Annual Biosimilars Congregation 2024
15:00 – Afternoon Tea / Coffee
11th December 19th Annual Biosimilars Congregation 2024
MARKET ACCESS
15:20 – Panel Discussion - Market Access - Implications for product launch and market exclusivity
• The Business of Biosimilars: Strategically exploring options for sustainability amidst hurdles faced by biosimilars market
• Understanding how product launches are influenced
• Ensuring pathways for innovative cures
• Identify best practices developed in foreign markets
• Discussing strategies for negotiating favorable access and reimbursement rates for biosimilars against originator biologics
• Who can influence payers on Biosimilar decision making
• Entry strategies, countermeasures to economic impact & marketing channels
• Key factors that impacting market and economic growth
• New product and existing product strategies to maintaining sustainability in biosimilars
Moderator
VISHWAS SOVANI, Founder Director, Pharmawisdom
Panellists
SANCHIT NANDA, Senior Director, Global Patient Solutions, Gilead Sciences
SANJAY B. NIRANJAN, Assistant Director, Bioassay Development (Biosimilars), Lupin
PANKAJ THAKUR, GM, Clinical Project Management - Drug Discovery, Biologics, Hetero Labs
SHALU KASLIWAL, Founder & Managing Director, Klinforsche Clinical Science
SEEMA BHANDARKAR, Global Program Manager Biosimilar Operations, Biocon
11th December 19th Annual Biosimilars Congregation 2024
RWE
16:10 – PANEL DISCUSSION: RWE - What type of evidence will be needed for registering Biosimilars in the future?
• Identify the tendencies and different perspectives on the evolution of data requirements for licensing of biosimilars
• Benefits of RWE for Biosimilars and special populations
• Designing & conducting RWE studies
• Real-world Data from multiple sources to conduct Biosimilar comparison studies
• Devise plans for implementation while leveraging perspectives from other markets
• Best practices & lessons learnt from past
• Penetrating the biosimilars marketplace - What comes next for the biosimilars market?
Moderator
KAVITA LAMROR, Partner, RWE & Digital Transformation, Maxis Clinical Sciences
Panellists
SANTOSH TAUR, Director Medical Affairs, Vaccines, Rare Diseases & Digital, Pfizer
SOURABH FULMALI, Global Medical Director, GSK
ABHISHEK SINHA, Vice President and Head - Global Regulatory Affairs, Advanz Pharma
MAYUR MAYBHATE, Head Medical Affairs, Alkem Laboratories
PRITHWIJIT KUNDU, CMO - NCE, NDD, Wockhardt
AMARNATH SUGUMARAN, Associate Director & Cluster Head Medical Affairs, Cipla
DATTATRAY PAWAR, Head Medical Affairs - Deputy G, Alkem Laboratories
11th December 19th Annual Biosimilars Congregation 2024
17:00 - Closing remarks and end of conference
29th August 4th Annual Pharma Innovation Tech Congress 2024
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
29th August 4th Annual Pharma Innovation Tech Congress 2024
09:20 – Welcome address & opening remarks
29th August 4th Annual Pharma Innovation Tech Congress 2024
RWE
09:30 – RWE and Whole Person Health
• What is Whole Person Health?
• What are the factors determining Whole Person Health?
• How is RWE related to Whole Person Health?
• What are some examples of Whole Person Health programs?
• What are the next steps in integrating RWE in Whole Person Health?
• What are the complexities and challenges of using RWE?
• What does the future of RWE in Healthcare look like?
KAVITA LAMROR, Partner, RWE & Digital Transformation, Maxis Clinical Sciences
29th August 4th Annual Pharma Innovation Tech Congress 2024
RWE & RWD
10:10 – DISCUSSION WITH EXPERTS: Industry game changer: RWE and RWD
• What is pharma buzzing about RWD & RWE?
• Role of RWE and RWD in pharma industry
• The potential usage of real-world evidence in clinical trials
• Advantages of RWE in regulatory-decision making.
• RWD & RWE for Clinical Trials
• How does real world data help in understanding disease and diagnosis in the beginning stage?
• Involvement of RWE and RWD in drug development
• Regulatory submission – What are the roadblocks when using RWD?
• RWE in HTA submissions
• Challenges with RW study designs and possible solutions
Moderator
VIVEK JHA, Head - Strategy & Operations, Global Drug Development - India, Novartis
Panellists
SANGEET KUMAR, Director Real World Analytics, Bristol Myers Squibb
GNANADEV GUDIPATI, Vice President ARD & QC, Natco Pharma
KAVITA LAMROR, Partner, RWE & Digital Transformation, Maxis Clinical Sciences
GURPREET SINGH, VP, Managing Director Integrated Safety, IQVIA
PRUDHVI TEJA, Principal & Head DPEx (Digital & Process Excellence), CTOs (API), Dr. Reddy’s Laboratories
RAJEEV KUMAR, Delivery Head / Practice Lead - HEOR & RWE, TCS
29th August 4th Annual Pharma Innovation Tech Congress 2024
11:10 – Morning Coffee / Tea & Discussion
29th August 4th Annual Pharma Innovation Tech Congress 2024
BIG DATA & BLOCKCHAIN
11:40 – DISCUSSION WITH EXPERTS: Analyzing big opportunities in big data & unblocking new ways in blockchain
• Big Pharma meets Big Data – Analysing innovations
• How big data can revolutionize pharmaceutical R&D
• Fast-tracking the research will reduce the cost of medicine – How big data plays a role
• Recent strategies for efficient usage of big data in drug discovery, clinical aspects and trials.
• Why Big Pharma Is Betting on Blockchain?
• Attaining better transparency secured data and automated operations in blockchain
• Building Blockchain transparent supply to help organizations build blockchain-based ecosystem networks quickly and easily.
• Fighting against counterfeiting medicines–Usage of blockchain
• Maintaining privacy in patient health records and data
Moderator
PUSHPA VIJAYARAGHAVAN, Director, Sathguru Management Consultants
Panellists
BIKRAM KESHARI PANDA, DPEx (Mfg.)-FTO HO, Dr. Reddy’s Laboratories
DOLITA KUMARI, Associate Director - Business Consulting / Lifescience Industry, Novartis
APARNA VADLAMUDI, AI & Innovation Director, Novartis
DEBABRATA SANYAL, GM - Corporate Quality Assurance (Group Head - Digital Automation), MSN Laboratories
ABDULLAH SALEEM, Group CIO, OMNI Hospitals
29th August 4th Annual Pharma Innovation Tech Congress 2024
12:30 – Realizing Digitalization through Scitara Digital Lab Exchange
• One platform for your connectivity needs
• ASM formats and FAIR aspects
• Querying lab assets through Strands
DEVDUTT SHASTRI, Director of Product Management, Scitara
29th August 4th Annual Pharma Innovation Tech Congress 2024
13:00 – Networking luncheon
29th August 4th Annual Pharma Innovation Tech Congress 2024
DIGITAL TRANSFORMATION
14:10 – DISCUSSION WITH EXPERTS: Digitalisation - How is digital transformation impacting the Pharma Industry?
• Reshaping Pharma industry in the way of digital transformation.
• Digitized clinical trials – New ways and barriers.
• How should your company prepare for this digital transformation wave?
• Challenges and opportunities in moving to digitalisation?
• How patients are involved in digital age in Pharma industry? Is their information secured? What is to be done?
• Improving drug development and better patient interaction and care- How digital transformation helps?
• How does digitalization help with transparency of the supply chain?
• Do digital trends really help in manufacturing? How?
• Assisting with operational changes and improvements
Moderator
ABHINAV WANKAR, DGM Operations, AIG Hospitals
Panellists
PRADIP KUMAR SASMAL, VP & Delivery Manager – IPDO BRaIN R&D, Dr. Reddy’s Laboratories
KAMARAJ ABRAHAM, Associate VP, Head Quality Assurance, Aurobindo Pharma
RAMKUMAR ESAKKI, Senior Vice President, Suven Pharma
DAMODHARAN MUNIYANDI, Chief Quality Officer - Global Quality & Regulatory Affairs, Sai Life Sciences
VARAHABHATLA SARMA, Corporate Head – IT, Vasudha Pharma
SHYAM AKKU, GM - International Marketing & Regional Head CIS, Hetero
29th August 4th Annual Pharma Innovation Tech Congress 2024
AI & TRIALS
15:00 – AI Evolution and Pharma Industry
• AI for Trial Design Optimization
• Role of AI in Patient Recruitment and Maintenance
• Digital Assistant for Regulatory Content creation
• Future Outlook
AMRITANSHU KUMAR, RWE Group Lead, Novartis
29th August 4th Annual Pharma Innovation Tech Congress 2024
15:30 – Afternoon Tea / Coffee
29th August 4th Annual Pharma Innovation Tech Congress 2024
AI / ML / GenAI
15:50 – DISCUSSION WITH EXPERTS: Evaluating and enlarging usage of AI and IoT in Pharma & Healthcare World
• How can AI change Pharma & Healthcare industry? Why, How & When of AI in pharmaceutical industry
• How is AI resolving the tech problems faced by the industry? How will the near future be?
• How was AI being put to utilize in the battle against the epidemic?
• AI in medical writing
• Challenges in AI, especially a lack of data integration and access of data?
• Major threats and challenges of drug discovery by AI
• How does ML provide custom-made treatment and behavioral alteration?
• Ways to improve drug development, clinical trials and monitoring through ML
• Is ML a solution for pharma logistics challenges?
• ML in medical devices. How does ML make things easier?
Moderator
RITHESH PHALAKSHA, Director - Leading Technology Acceleration (Digital Solutions), Novartis
Panellists
SONICA SACHDEVA BATRA, Associate VP, Enterprise Medical, Indegene
RAMAKRISHNAN VENKATARAMANAN, Director Global Product Development and Supply IT India Lead, Bristol Myers Squibb
RAHUL YELISETTI, Head Digital & Process Excellence, API, Dr. Reddy’s Laboratories
DIVYA BIJLWAN, Global Director Strategic Programs, GSK
BALARAM PATRO, CEO, GRK Research Laboratories
LAKSHMI NARAYANA, Director, Supply Chain Management, Aragen
SAURABH GUPTA, Regional Chief Operating Officer, KIMS Hospitals
29th August 4th Annual Pharma Innovation Tech Congress 2024
17:00 – Closing remarks and end of conference