39th Pharmacovigilance India 2025
39th Pharmacovigilance India 2025
19th & 20th November, 2025
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
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Event Schedule
Meet to learn and network with your conference colleagues.
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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“The conference was a remarkable opportunity for networking with other experts in our field. Every session was enlightening, and I’m eager to apply what I learned to my business right away. As I noted during the event, your dedication is commendable! You’ve gathered an extraordinary group of speakers, and the empowering connections made with fellow pharmacovigilance colleagues on the panels and in keynote speeches were truly inspiring.”
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