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39th Pharmacovigilance India 2025

39th Pharmacovigilance India 2025

19 & 20 November, 2025

Kohinoor Continental Hotel, 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.

    Key Focus Areas

    Event Speakers

    RAJ K BHOGAL

    Jazz Pharmaceuticals

    PRASAD D

    Cipla

    PRATIK SHAH

    Bharat Serums and Vaccines

    VIPIN SETHI

    BioMatrix Healthcare

    RAHUL GUPTA

    USV

    GEETA SHANBHAG

    Ipca Laboratories

    RAJENDRA K K

    Glenmark

    ARUNIMA SEN

    Viatris

    GIRIJAA KADAM

    Sanofi

    SANTOSH TAUR

    Pfizer

    VAIBHAV SALVI

    Sanofi

    PRABHAT SINHA

    Boehringer Ingelheim

    SHIRAZ K

    Ferring Pharmaceuticals

    SAKSHI S D

    Johnson & Johnson

    MUKESH GORI

    Amgen

    INDU NAMBIAR

    Sanofi

    SOURABH F

    GSK

    ROHINI PANDEY

    Abbott

    HARSHAD MALVE

    Kenvue

    DHWANI D

    Otsuka Pharmaceutical

    JAMAL BAIG

    MSD Pharmaceuticals

    RENUKA NEOGI

    Sun Pharma

    JEROZE DALAL

    GSK

    DEVANG PATEL

    Zydus Lifesciences

    MAYUR M

    Alkem Laboratories

    RAHUL SOMANI

    Alkem Laboratories

    SHREYA D

    Novartis

    APARNA P

    Wockhardt

    VASU MORLA

    Novartis

    PRTHWIJIT K

    Wockhardt

    SUNIL HONKALAS

    Fresenius Kabi

    VYNIE ANN RAO

    Glenmark

    SUCHITA MORE

    MSD

    CHITRA BARGAJE

    Lupin

    SUSHMITA KUSWA

    Piramal

    KAVITA LAMROR

    Maxis Clinical Sciences

    OMPRAKASH S. SADHWANI

    FDA (Former)

    SHRADDHA B 

    Sandoz

    KHOKAN D

    Wockhardt

    BIJENDER M

    Alkem Laboratories

    RASHMI HEGDE

    GSK (Former)

    MARTINA GOMES

    Bayer Pharmaceuticals

    ANUJA JAWALE

    Kenvue (Division of J&J)

    MEERA NAGARIA

    Johnson & Johnson

    MUGDHA SHAH

    Sanofi

    JYOTI KASHID

    Lundbeck

    CHAITANYA K

    Marksans Pharma

    VISHWAS SOVANI

    Pharmawisdom

    SUNIL NIGHOT

    Kenvue (Division of J&J)

    Book Now
    ×

    Download Brochure

      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
      09:40 – Keynote Address – Strategy for global PV system inspection readiness

      INSPECTION READINESS

      • Who needs to be ready
      • Factors for consideration when supporting global inspections
      • Common areas of non-compliance
      • Management of responses

      Speaker

      RAJ K BHOGAL

      Sr. Director, R&D Business Strategy & Operation

      Jazz Pharmaceuticals (UK)

      10:20 – 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
       
      Sr Vice President
       
      BioMatrix Healthcare

      Panellists

      RAJENDRA KUMAR KASI

      VP & Global Head – Pharmacovigilance

      Glenmark

      INDU NAMBIAR

      Pharmacovigilance Lead & Country Safety Head

      Sanofi

      SAKSHI SHRIVASTAVA DESAI

      Director, LMS regional Lead APAC

      Johnson & Johnson

      CHAITANYA KULKARNI

      GM Pharmacovigilance

      Marksans Pharma

      11:10 – Morning Coffee/Tea & Discussion
      11:40 – 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

      Director, Drug Safety
       
      MSD Pharmaceuticals

      SHRADDHA BHANGE

      Senior Medical Safety Lead

      Sandoz

      12:40 – 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

      GIRIJAA KADAM

      Director – Global Safety Officer

      Sanofi

      JEROZE DALAL

      Head of Clinical Operations, Governance & Risk Management

      GSK

      CHITRA BARGAJE

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

      Lupin

      VASU MORLA

      Global GCP/PV Auditor

      Novartis

      SUNIL HONKALAS

      Senior DGM, Medical & PV

      Fresenius Kabi

      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 – External Service/Supplier Qualification: Challenges and Outcomes

      Speaker

      SHREYA DESHPANDE

      Global Development Quality Manager

      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

      ARUNIMA SEN

      Associate VP, Product Safety and Risk Management

      Viatris

      Panellists

      MUKESH GORI

      Director Global Patient Safety

      Amgen

      RAHUL SOMANI

      Head- Global Pharmacovigilance

      Alkem Laboratories

      ROHINI PANDEY

      Regional PV Head- SEA

      Abbott

      VYNIE ANN RAO

      Senior Manager

      Glenmark

      JYOTI KASHID

      Manager, Global Patient Safety Operations

      Lundbeck (Singapore)

      17:00 - Closing remarks and end of conference
      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 – Strategy for global PV system inspection readiness

      INSPECTION READINESS

      • Who needs to be ready
      • Factors for consideration when supporting global inspections
      • Common areas of non-compliance
      • Management of responses

      Speaker

      RAJ K BHOGAL

      Sr. Director, R&D Business Strategy & Operation

      Jazz Pharmaceuticals (UK)

      10:10 – 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
       
      Sr Vice President
       
      BioMatrix Healthcare

      Panellists

      RAJENDRA KUMAR KASI

      VP & Global Head – Pharmacovigilance

      Glenmark

      INDU NAMBIAR

      Pharmacovigilance Lead & Country Safety Head

      Sanofi

      SAKSHI SHRIVASTAVA DESAI

      Director, LMS regional Lead APAC

      Johnson & Johnson

      KRUNAL DALAL

      Head Medical Affairs

      GSK

      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

      Director, Drug Safety
       
      MSD Pharmaceuticals

      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

      GIRIJAA KADAM

      Director – Global Safety Officer

      Sanofi

      JEROZE DALAL

      Head of Clinical Operations, Governance & Risk Management

      GSK

      CHITRA BARGAJE

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

      Lupin

      VASU MORLA

      Global GCP/PV Auditor

      Novartis

      SUNIL HONKALAS

      Senior DGM, Medical & PV

      Fresenius Kabi

      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 – External Service/Supplier Qualification: Challenges and Outcomes

      Speaker

      SHREYA DESHPANDE

      Global Development Quality Manager

      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

      ARUNIMA SEN

      Associate VP, Product Safety and Risk Management

      Viatris

      Panellists

      MUKESH GORI

      Director Global Patient Safety

      Amgen

      RAHUL SOMANI

      Head- Global Pharmacovigilance

      Alkem Laboratories

      ROHINI PANDEY

      Regional PV Head- SEA

      Abbott

      VYNIE ANN RAO

      Senior Manager

      Glenmark

      JYOTI KASHID

      Manager, Global Patient Safety Operations

      Lundbeck (Singapore)

      17:00 - 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

      DGM – 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

      PRASAD DESHMUKH

      Vice President & Head Pharmacovigilance

      Cipla

      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

      SUSHMITA KUSWA

      Head Medical & Regulatory Affairs

      Piramal

      DEVANG PATEL

      Head of Global Pharmacovigilance

      Zydus Lifesciences

      MUGDHA SHAH

      PV Audit and Inspection Readiness Manager

      Sanofi

      SUNIL NIGHOT

      Manager, ICSR Quality

      Kenvue (Division of J&J)

      12:10 - Explainable AI: Why you see What you see

      Break the black box: Generating explainability behind predictive models is quite a challenge. Hence to mitigate it, we have developed a novel technique which helps us understand the relationship between the input and the output in a more human understandable format.

      Speaker

      MEERA NAGARIA

      Senior Data Scientist

      Johnson & Johnson (Boston, USA)

      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

      Senior Vice President and Head of Medical Affair

      Bharat Serums and Vaccines

      SANTOSH TAUR

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

      Pfizer

      PRTHWIJIT KUNDU

      Chief Medical Officer NCE NDD

      Wockhardt

      HARSHAD MALVE

      Medical Head – Self-Care & Operations

      Kenvue

      MAYUR MAYBHATE

      Head Medical Affairs

      Alkem Laboratories

      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 – Area Safety Head – India and South Asia Cluster

      Kenvue (Division of J&J)

      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

      OMPRAKASH S. SADHWANI

      Former Joint Commissioner & Controlling Authority

      FDA (Maharashtra State)

      Panellists

      RAHUL GUPTA

      Senior 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

      KHOKAN DEBNATH

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

      Wockhardt

      16:50 – Lucky Draw / Closing remarks & 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

      DGM – 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

      PRASAD DESHMUKH

      Vice President & Head Pharmacovigilance

      Cipla

      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

      SUSHMITA KUSWA

      Head Medical & Regulatory Affairs

      Piramal

      DEVANG PATEL

      Head of Global Pharmacovigilance

      Zydus Lifesciences

      MUGDHA SHAH

      PV Audit and Inspection Readiness Manager

      Sanofi

      SUNIL NIGHOT

      Manager, ICSR Quality

      Kenvue (Division of J&J)

      12:10 - Explainable AI: Why you see What you see

      Break the black box: Generating explainability behind predictive models is quite a challenge. Hence to mitigate it, we have developed a novel technique which helps us understand the relationship between the input and the output in a more human understandable format.

      Speaker

      MEERA NAGARIA

      Senior Data Scientist

      Johnson & Johnson (Boston, USA)

      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

      Senior Vice President and Head of Medical Affair

      Bharat Serums and Vaccines

      SANTOSH TAUR

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

      Pfizer

      PRTHWIJIT KUNDU

      Chief Medical Officer NCE NDD

      Wockhardt

      HARSHAD MALVE

      Medical Head – Self-Care & Operations

      Kenvue

      MAYUR MAYBHATE

      Head Medical Affairs

      Alkem Laboratories

      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 – Area Safety Head – India and South Asia Cluster

      Kenvue (Division of J&J)

      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

      OMPRAKASH S. SADHWANI

      Former Joint Commissioner & Controlling Authority

      FDA (Maharashtra State)

      Panellists

      RAHUL GUPTA

      Senior 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

      KHOKAN DEBNATH

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

      Wockhardt

      16:50 – Lucky Draw / Closing remarks & end of conference
      Book Now
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        Event Sponsors 

        We wouldn’t be able to host our conferences without help from these amazing companies. A huge thanks to all our sponsors and partners!

        Exhibitors

        Amethys Insights Pvt. Ltd., formerly SRS HEOR, a business unit of SRS Pharmaceuticals Pvt. Ltd., became an independent entity in 2024 to meet the evolving needs of the pharmaceutical and healthcare sectors. Our mission is to empower small and mid-sized pharmaceutical companies by providing safe, effective, and compliant medicinal products through robust pharmacovigilance services. At Amethys Insights, we offer end-to-end pharmacovigilance solutions designed to enhance drug safety and protect patient well-being globally. We provide comprehensive services to track, assess, and report adverse drug reactions (ADRs), ensuring compliance with international pharmacovigilance regulations. Our cloud-based safety database system streamlines submissions and accelerates processes, adhering to Good Pharmacovigilance Practices (GVP), ICH guidelines, and local regulations. We prioritize data security and compliance with global standards, holding ISO 27001:2022 and ISO 27701:2019 certifications. Our services comply with GDPR, HIPAA, and 21 CFR Part 11, ensuring full regulatory adherence.

        Conceptualized By 

        Virtue Insight was founded in 2009. We equip business professionals around the world with the latest in-depth industry knowledge and provide networking opportunities in telecom, technology and pharmaceutical industries. Our aim is to provide a platform to share knowledge, insight and provide our clients to network effectively and deliver maximum ROl by making new business alliances.
        • Phone:+91 44 42108101
        • Email:info@virtueinsight.com

        Supported By 

        All Conference Alert is the trusted partner for academician and practitioners to search browse and schedule their calendar to attain a proper international platform for research and b to b interaction of their interest. ACA is the best conference search engine to post, index and promote your conference worldwide.
        • Phone:+91 89250 31783
        • Email:info@allconferencealert.com

        Event Testimonials

        A huge thanks to all our sponsors, attendees and partners!

        Remarkable Event

        “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.”

        Kenvue Manager, ICSR Quality, Medical Safety, Performance & Compliance
        Good

        It was very beneficial & effective conference. Got an opportunity to meet members from PV world & learn new areas if AI, Drug Development. Would defiantly visit again if given an opportunity.

        Global Safety & PV Associate, Syneos Health
        Great Event

        A great platform to understand the current practices & situation all across the industry, as well as individual approach of each company toward the goal of patient safety

        Senior Executive, Lupin
        Great Event

        I would like to appreciate the efforts & initiative of Virtue Insight in organising the 17th Pharmacovigilance 2018 dedicated conference. The conference was very much interesting & was a good platform for networking, It was well organised, very insightful & a informative conference. The whole conference was more lively & in particular the panel discussions. This should happen regularly to keep PV professional updated. I have enjoyed the whole conference very much.

        Senior Drug Safety Executive, IPCA Laboratories
        Great Event

        Had wonderful opportunity to share current challenges with Regulatory aspects of Pharmacovigilance.  Very informative conference and very much needed to educated all the stake holders considering current scenario of Pharmacovigilance within our regulatory. We had very interesting discussion on CRO role for end to end Pharmacovigilance. I enjoy the way Dr. Milind handled our Panel discussion.

        Founder & Chief Executive Officer, Nucleon Therapeutics

        Very nicely managed. Good Speakers & content. Cooperative and convenient venue. Nice management of time. Good opportunity for networking

        Assistant Manager – Pharmacovigilance, Mega Lifesciences

        The Venue, key speakers included from big pharma companies & CROs has been perfect for the topic of panel discussion

        MSA, George Clinical

        The session was knowledge transfer/sharing and valuable too

        Associate Manager, IQVIA (formerly known QuintilesIMS)

        Panel discussions are very interactive as well as address real world and practical issues

        Head – Medical Affairs, Wockhardt

        A commercial knowledge venture explored several areas under the topic. Very good and Professional speakers.

        Director, SYNORBS BIOSOLUTIONS

        This kind of conference is very important for younger generations and professionals to get mere awareness and day to day updates in markets

        CIO, Qtech Solutions

        The content of the conference is always good. Good to see speakers from regulatory authorities. Always delighted to attend your conference.

        Medical Services, Cipla

        Great conference, great people, great presentations, - thanks to you and Virtue Insight team for running everything smoothly!

        Senior Manager Global Patient Safety, Amgen

        Kudos to the organizing team – you did it again! A very good networking opportunity, highly recommending this to young professionals as well. Excellent panel discussions and presentations, with a variety of topic of interest, all very actual in the field of pharmacovigilance and beyond. Also not to neglect: great venue and food.

        Country Head Pharmacovigilance Deputy EU QPPV, Bayer

        I enjoyed the conference. It was very well organised and knowledgeable. It gave me a scope to understand the current affairs in the Pharmacovigilance industry and also got a chance to meet the experts in this field.

        Drug Safety Executive - Corporate Pharmacovigilance Cell, Ipca Laboratories

        It's my pleasure as a speaker at the 29th Pharmacovigilance India 2022 from Virtue Insight Conference, It was a great experience sharing knowledge with Industry experts, interacting with leaders, speakers, professionals, guests, and spreading awareness about Pharmacovigilance in society with learning new things.  Many thanks for the support and for encouraging all to be more vigilant on medicines and the Healthcare system by organizing excellent conferences.

        Manager – Quality & Compliance (PV), Ipca Laboratories

        Well organized & good topics covered by experienced speakers

        Senior Manager, Fresenius Kabi

        The overall sessions were good with enlightening information

        Assistant Manager, Glenmark

        It’s a very good place to connect with all PV professionals from different sponsors from India includes some top most

        Manager – PV, Jeevan Scientific Technology

          Pricing Details

          Exclusive Offer — 3 Delegates for the Price of 2!

          STANDARD PRICE — INR 21,000 + GST (18%) PER DELEGATE

          You can simply email or call and book your conference delegate seats on:

          TEL: + 91 44 42108101 (or) Email — bookings@virtueinsight.com

          CONFERENCE SPONSOR & EXHIBITION STALL

          Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to:

          TEL: + 91 44 42108101 (or) Email — bookings@virtueinsight.com

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            Venue Details

            The venue is easily accessible, well-equipped with modern amenities, and offers a comfortable, professional setting for all attendees.

            Venue –
            Kohinoor Continental Hotel, Mumbai, India
             

            Andheri Kurla Road, Andheri ( E )
            Mumbai 400059 – India

            91 22 66919000 / 91 22 28209999

             

            Venue

            Kohinoor Continental Hotel, Mumbai,

            India

            Andheri Kurla Road, Andheri ( E )
            Mumbai 400059 – India

            91 22 66919000 / 91 22 28209999

            Get Involved

            Conference Production

            Speaking Opportunities

            Fen Castro
            fen@virtueinsightevents.com
            +91 44 42108101
            Speaking Opportunities

            Sponsorship and Delegate Enquiry

            Piyush Patel
            piyush@virtueinsightevents.com
            +44 20 3509 3779
            #VIphv39pharmaPharmacovigilance
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