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39th Pharmacovigilance India 2025

39th Pharmacovigilance India 2025

19th & 20th November, 2025

Mumbai, India

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    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

    SOMNATH BASU

    National Regulatory Authority for Drugs

    MAYUR PARMAR

    FDA

    KHAUDEJA BANO

    Amgen (USA)

    RAJ K BHOGAL

    Jazz Pharmaceuticals

    PRASAD D

    Cipla

    PRATIK SHAH

    Bharat Serums and Vaccines

    VIPIN SETHI

    Cadila

    RAHUL GUPTA

    USV

    MILIND ANTANI

    Nishith Desai Associates

    GEETA SHANBHAG

    Ipca Laboratories

    SANTOSH TAUR

    Pfizer

    VAIBHAV SALVI

    Sanofi

    PRABHAT SINHA

    Boehringer Ingelheim

    RISHI JAIN

    Novartis

    SHIRAZ K

    Ferring Pharmaceuticals

    SAKSHI S D

    Johnson & Johnson

    MUKESH GORI

    Novartis

    INDU NAMBIAR

    Sanofi

    SOURABH F

    GSK

    ROHINI PANDEY

    Abbott

    HARSHAD MALVE

    Kenvue

    JYOTSNA P

    Novartis

    DHWANI D

    Otsuka Pharmaceutical

    JAMAL BAIG

    Sanofi

    RENUKA NEOGI

    Sun Pharma

    SADANAND K

    Fresenius Kabi

    JEROZE DALAL

    GSK

    MAYUR M

    Alkem Laboratories

    KRUNAL DALAL

    GSK

    RAHUL SOMANI

    Alkem Laboratories

    APARNA P

    Wockhardt

    VYNIE ANN RAO

    Lupin

    SUCHITA MORE

    MSD

    CHITRA BARGAJE

    Lupin

    GIRISH SANE

    Bristol Laboratories

    KAVITA LAMROR

    Maxis Clinical Sciences

    SHRADDHA B 

    Sandoz

    KHOKAN D

    Wockhardt

    BIJENDER M

    Alkem Laboratories

    RASHMI HEGDE

    GSK (Former)

    JOYDEEP S

    Sun Pharmaceuticals

    MARTINA GOMES

    Bayer Pharmaceuticals

    ANUJA JAWALE

    Organon

    MEERA NAGARIA

    Johnson & Johnson

    SOUVIK C

    Novartis

    MUGDHA SHAH

    Sanofi

    JYOTI KASHID

    Lundbeck

    VANSHIKA B

    Novartis

    KUSHAL SARDA

    Shalina Healthcare

    CHAITANYA K

    Marksans Pharma

    VISHWAS SOVANI

    Pharmawisdom

    Book Now
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      Event Schedule

      Meet to learn and network with your conference colleagues.

      19th November
      20th November
      08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
      09:20 – Welcome address and Opening Remarks
      09:30 – Keynote Address - Safety Reporting - Aspiration of a global integrated ecosystem.

      SAFETY

      Speaker

      KHAUDEJA BANO

      Vice President Combination Product Quality

      Amgen (USA)

      10:00 – Keynote Panel Discussion: Pharmacovigilance for Tomorrow: Navigating Challenges and Uncovering Opportunities

      CHALLENGES & OPPORTUNITIES

       

      • Tackle data overload and integration barriers in effective PV implementation.
      • Examine the gaps between pre-marketing potential and post-marketing reality.
      • Question if accelerated drug approvals compromise patient safety.
      • Explore complexities in adopting AI and automation within PV systems.
      • Discuss challenges in global literature monitoring for drug safety.
      • Identify misconceptions, misuse, and underrecognized factors in ADR causation.

      Moderator

      VIPIN SETHI


      VP International Business, Head Global PV Function


      Cadila

      Panellists

      RISHI JAIN


      Country Medical Head


      Novartis

      INDU NAMBIAR


      Pharmacovigilance Lead & Country Safety Head


      Sanofi

      SAKSHI SHRIVASTAVA DESAI


      Associate Director International PV Strategy
      Realization

      Johnson & Johnson

      KRUNAL DALAL


      Head Medical Affairs


      GSK

      GIRISH SANE


      GM & Head Pharmacovigilance


      Bristol Laboratories

      CHAITANYA KULKARNI


      GM Pharmacovigilance


      Marksans Pharma

      11:00 – Morning Coffee/Tea & Discussion
      11:30 – Panel Discussion: Patient-Centric Pharmacovigilance: Amplifying the Patient Voice in Drug Safety

      PATIENT SAFETY

       

      • Address unconscious bias in pharmacovigilance and explore mitigation strategies.

       

      • Trace the shift from reactive to proactive patient safety models.


      • Examine the role of patient input in signal detection and ADR prevention.


      • Highlight the importance of protecting vulnerable patient groups.


      • Discuss challenges in patient engagement, including tech access and language barriers.


      • Emphasize the value of patient-reported outcomes in improving safety reporting and empowerment.


      • Explore how public awareness enhances pharmacovigilance systems and data quality.

       

      Moderator

      VISHWAS SOVANI


      Founder Director


      Pharmawisdom

      Panellists

      VAIBHAV SALVI


      Director & Head – Clinical Study Unit, India & South East Asia


      Sanofi

      SOURABH FULMALI


      Global Medical Director – Respiratory


      GSK

      RENUKA NEOGI


      Head & Deputy GM – Global Clinical Quality Management


      Sun Pharma

      JAMAL BAIG


      Multi Country Safety Head


      Sanofi

      SHRADDHA BHANGE


      Senior Medical Safety Lead


      Sandoz

      12:20 - Topic TBC

      For sponsorship opportunities please contact info@virtueinsight.com

      12:50 – Networking luncheon
      13:50 – Panel Discussion - The “Next Generation” risk management strategies

      RISK MANAGEMENT

       

      • Implementation and maintenance of RMP’s – Overcoming its challenges


      • Potential analyzing of safety and risk signals in PV


      • Strategies to minimize the risk measures – what are the new developments?


      • Benefit/Risk ratio: the common Denominator


      • Stakeholders in RMP – Communications must be improved


      • Implementing a Risk-Based Monitoring Solution: Understanding the basics of a sustainable model


      • Discussing about the strategies that support the PV from beginning to end

      Moderator

      VISHWAS SOVANI


      Founder Director


      Pharmawisdom

      Panellists

      PRASAD DESHMUKH


      Vice President & Head Pharmacovigilance


      Cipla

      JEROZE DALAL


      Head of Clinical Operations, Governance & Risk Management

      GSK

      CHITRA BARGAJE


      Sr.GM, Global Head PV, Drug Safety & Risk Management

      Lupin

      14:40 - Regulations on Pharmacovigilance in India

      REGULATORY

       

      • Regulations overview


      • Practical scenario/ scope of improvement


      • Interface of PV with regulatory


      • Best practices across the global on PV practices

      Speaker

      MARTINA GOMES


      Head, Reg Affairs – CH, South Asia


      Bayer

      15:10 – Afternoon Tea/Coffee
      15:40 – Validation and Regulatory Compliance of Artificial Intelligence/Machine Learning enabled PV Systems

      • Regulatory requirement of validation of AI-enabled and automated tools for PV.


      • Computerized System Validation (CSV) vs Computer Software Assurance (CSA).


      • Risk detection, assessment and mitigation of AI Systems


      • AI system life cycle management —from pilot to production —innovation with compliance


      • Regulatory Inspections of computerized systems in PV

      Speaker

      SOUVIK CHATTERJEE


      Senior Global Auditor


      Novartis

      16:10 – Panel Discussion: Outsourcing in Pharmacovigilance: Evolving Models, Strategic Partnerships & Global Impact

      OUTSOURCING

       

      • Explore outsourcing as a strategic tool to access expertise and scale operations.


      • Evaluate the pros and cons of outsourcing pharmacovigilance activities.


      • Understand key concerns around training, infrastructure, and partner readiness.


      • Examine cost-efficiency and budget optimization through outsourced PV systems.


      • Identify best practices for building strong, effective PV partnerships.


      • Learn from successful collaborations that have enhanced global drug safety.


      • Respond to rising case volumes with scalable, tech-enabled PV outsourcing models.


      • Fostering quality culture in vendor environments

      Moderator

      Panellists

      MUKESH GORI


      Associate Director -ESP Management CMO & PS


      Novartis

      RAHUL SOMANI


      Head- Global Pharmacovigilance


      Alkem Laboratories

      ROHINI PANDEY

      Regional PV Head- SEA

      Abbott

      VYNIE ANN RAO


      Drug Safety & Risk Management Manager


      Lupin

      JYOTI KASHID


      Manager, Global Patient Safety Operations


      Lundbeck (Singapore)

      VANSHIKA BRIJWANI


      Manager Country Development Quality (CDQ)


      Novartis

      17:00 - Closing remarks and end of conference
      08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues
      09:20 – Welcome address and opening remarks
      09:30 – Driving Packaging Excellence in Pharma: A Strategic Shift from Function to Future

      PACKAGING

      •   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

      Speaker

      SHRINIWAS SINGH

      HOD Packaging Development

      Themis Medicare

      10:00 – DISCUSSION WITH EXPERTS: Pharma Serialization and Track & Trace: Ensuring Supply Chain Integrity and Patient Safety

      SERIALIZATION, TRACK & TRACE

      •   Track-and-trace in improving visibility and accountability across the pharmaceutical supply chain
      •   Recent updates over serialization of 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

      10:50 – Morning Tea/Coffee & Networking
      11:20 – DISCUSSION WITH EXPERTS: Panel discussion with experts: Driving innovation and sustainability in pharma packaging: Trends, challenges and opportunities

      PACKAGING, LABELLING

      •   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

      12:10 – Barcoding Technology - Game changer in consumer behaviour

      LOKESH PATEL

      Founder Director

      URL Aseptic Automation

      12:40 - Networking luncheon
      13:40 – DISCUSSION WITH EXPERTS: Building agile and secure pharma supply chains: Adapting to global challenges and future opportunities

      SUPPLY CHAIN

      •   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

      14:30 – Future of pharmaceutical labelling: enhancing patient safety and engagement through digital innovation and regulatory compliance

      LABELLING

      •   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.

      15:00 – Afternoon Tea/Coffee
      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?

      Speaker

      SOMNATH BASU

      Team Leader of Reviewers of Drugs

      National Regulatory Authority for Drugs

      16:00 – DISCUSSION WITH EXPERTS: Navigating the Pharma Regulatory Maze: Compliance Strategies for Packaging, Labeling, Serialization and Track & Trace

      REGULATORY

      •   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

      16:50 - Closing remarks and end of conference
      08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
      09:30 - Materiovigilance in India: Strengthening Safety Structures for Medical Devices

      MATERIOVIGILANCE

       

      •   Distinct vigilance systems are needed for medicines and medical devices.


      •   Device safety and performance are critical to protecting patient health.


      •   Stakeholders must actively support post-market and market surveillance.


      •   Underreporting of adverse events limits effective risk evaluation.


      •   Continuous safety monitoring ensures regulatory compliance and trust.


      •   India’s materiovigilance framework must evolve with global best practices.

      Speaker

      APARNA PRABHUNE

      Assistant General Manager – Regulatory Affairs

      Wockhardt

      10:00 – Panel Discussion - The Digital Future of Pharmacovigilance: Innovation, Intelligence & Integration

      TECHNOLOGY

       

      •   Leverage big data and predictive modelling for early detection of safety signals.
      •   Utilize real-world data to enhance drug safety and operational excellence.
      •   Explore the growing role and impact of AI in pharmacovigilance.
      •   Integrate diverse data sources to strengthen data-driven safety decisions.
      •   Examine how digital tools are transforming communication across PV stakeholders.
      •   Assess the role of social media and digital platforms in adverse event reporting.
      •   Balance tech innovation with the need to uphold drug safety standards.
      •   Discuss innovation through drug repurposing and agile PV systems.

      Moderator

      RASHMI HEGDE

      Former Executive Vice President Medical Affairs

      GSK

      Panellists

      BIJENDER MISHRA

      Sr. GM & CISO

      Alkem Laboratories

      SUCHITA MORE

      Associate Director Medical Affairs

      MSD

      DHWANI DHOLAKIA

      Division Head – Information Technology

      Otsuka Pharmaceutical

      MEERA NAGARIA

      Senior Data Scientist

      Johnson & Johnson (Boston, USA)

      10:50 – Morning Coffee/Tea & Discussion
      11:20 – Panel Discussion- Managing Pharmacovigilance Audits & Inspections

      AUDITS & INSPECTIONS

       

      •   Staying ahead in the race – Current trends for and future guidelines


      •   How to prepare and what to expect?


      •   Remote audits and inspections – Logistical issues


      •   PV Inspection readiness: Keeping on the right side of inspectors


      •   Methodologies, scope and oversight


      •   Boldly shaping the future


      •   What has this pandemic thought us towards audits and inspections?

      Moderator

      RAJ K BHOGAL

      Sr. Director, R&D Business Strategy & Operations

      Jazz Pharmaceuticals (UK)

      Panellists

      JYOTSNA PATWARDHAN

      Cluster Head Clinical/PV QA at  Africa, Middle East, Turkey &

      India

      Novartis

      JOYDEEP SENGUPTA

      Global Pharmacovigilance – Site Head

      Sun Pharmaceuticals

      MUGDHA SHAH

      PV Audit and Inspection Readiness Manager

      Sanofi

      12:10 - Topic TBC

      For sponsorship opportunities please contact info@virtueinsight.com

      12:40 – Networking luncheon
      13:50 – Panel Discussion - Why RWD and RWE is crucial for Pharmacovigilance

      RWD / RWE

       

      •   Importance of real-world data for answering questions


      •   Benefits and challenges of evidence derived from real world sources


      •   Real World Evidence: How Does its Use challenge quality and compliance programs?


      •   Obtaining patient-centric using RWE


      •   Implications of RWE for Quality and Compliance


      •   What are complications that will rise by inserting new data source? Breakup in data?


      •   Identify the challenges involved in incorporating real world evidence into a structured benefit-risk assessment.

      Moderator

      KAVITA LAMROR

      Partner, RWE & Digital Transformation

      Maxis Clinical Sciences

      Panellists

      PRATIK SHAH

      Vice President Medical Affairs

      Bharat Serums and Vaccines

      SANTOSH TAUR

      Director Medical Affairs, Ex-Chair, RWE Council, ISCR

      Pfizer

      HARSHAD MALVE

      Medical Head – Self-Care & Operations

      Kenvue

      MAYUR MAYBHATE

      Head Medical Affairs

      Alkem Laboratories

      KUSHAL SARDA

      GM & Head – Medical Affairs, Clinical Research & PV

      Shalina Healthcare

      14:40 – Pharmacovigilance in South Asia: A Regional Perspective on Drug Safety Challenge

      Overcoming underreporting of ADRs due to cultural and socioeconomic factors. Developing community-centric approaches to improve PV participation.

      Speaker

      ANUJA JAWALE

      Associate Director – RA/PV Strategic Engagements &

      Vendor Management, Organon

      15:10 – Afternoon Tea/ Coffee & Networking
      15:40 - Panel Discussion – Regulatory: Current Scenario & Key Reforms Needed to Ensure Safer Drugs for Patients

      REGULATORY

      As the global pharmacovigilance landscape continues to evolve, the regulatory environment remains both a guiding framework and a formidable challenge. This session will explore the current regulatory scenario and assess what reforms are needed to ensure patient safety without stifling innovation.

       

      •   Navigating global PV compliance in an increasingly complex regulatory environment


      •   Adapting to intensified safety regulations and aligning with international expectations


      •   Leveraging real-world data and evidence to support regulatory decisions


      •   Addressing challenges in PV and MV reporting and submission frameworks


      •   Building inspection-ready systems to manage evolving and diverse regulatory demands


      •   Balancing global regulatory convergence with local adaptability and reduced industry burden

      Moderator

      MILIND ANTANI

      Leader, Pharma & Healthcare

      Nishith Desai Associates

      Panellists

      SOMNATH BASU

      Team Leader Reviewers of Drugs

      National Regulatory Authority for Drugs (NRA India)

      MAYUR PARMAR

      Drugs Inspector (Deputy Collector, Gujarat Government)

      FDA

      RAHUL GUPTA

      Vice President, Regulatory Affairs

      USV

      GEETA SHANBHAG

      VP – PV & Medico-Regulatory Affairs

      Ipca Laboratories

      PRABHAT SINHA

      Director Government & Public Affairs

      Boehringer Ingelheim

      SHIRAZ KANDAWALLA

      Associate Director

      Ferring Pharmaceuticals

      SADANAND KULKARNI

      Head- Medical, Regulatory, Vigilance & Quality

      Fresenius Kabi

      KHOKAN DEBNATH

      Sr. GM – Regulatory Affairs, Clinical Operations, PV & QA

      Wockhardt

      16:50 – Lucky Draw / Closing remarks & end of conference
      08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues
      09:20 – Welcome address and opening remarks
      09:30 – Driving Packaging Excellence in Pharma: A Strategic Shift from Function to Future

      PACKAGING

      •   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

      Speaker

      SHRINIWAS SINGH

      HOD Packaging Development

      Themis Medicare

      10:00 – DISCUSSION WITH EXPERTS: Pharma Serialization and Track & Trace: Ensuring Supply Chain Integrity and Patient Safety

      SERIALIZATION, TRACK & TRACE

      •   Track-and-trace in improving visibility and accountability across the pharmaceutical supply chain
      •   Recent updates over serialization of 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

      10:50 – Morning Tea/Coffee & Networking
      11:20 – DISCUSSION WITH EXPERTS: Panel discussion with experts: Driving innovation and sustainability in pharma packaging: Trends, challenges and opportunities

      PACKAGING, LABELLING

      •   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

      12:10 – Barcoding Technology - Game changer in consumer behaviour

      LOKESH PATEL

      Founder Director

      URL Aseptic Automation

      12:40 - Networking luncheon
      13:40 – DISCUSSION WITH EXPERTS: Building agile and secure pharma supply chains: Adapting to global challenges and future opportunities

      SUPPLY CHAIN

      •   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

      14:30 – Future of pharmaceutical labelling: enhancing patient safety and engagement through digital innovation and regulatory compliance

      LABELLING

      •   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.

      15:00 – Afternoon Tea/Coffee
      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?

      Speaker

      SOMNATH BASU

      Team Leader of Reviewers of Drugs

      National Regulatory Authority for Drugs

      16:00 – DISCUSSION WITH EXPERTS: Navigating the Pharma Regulatory Maze: Compliance Strategies for Packaging, Labeling, Serialization and Track & Trace

      REGULATORY

      •   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

      16:50 - Closing remarks and end of conference
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