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    • Past Conferences
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41st Pharmacovigilance USA 2026

41st Pharmacovigilance USA 2026

27 & 28 May, 2026

Boston, USA

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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.

    An Agenda Made For You

    High quality content that addresses your biggest challenges and uncovering hidden opportunities.

    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

    MARIETTE BOERSTOEL-S

    Bristol-Myers Squibb

    PHILISHA MACK

    Azurity Pharmaceuticals

    E. ALTON SARTOR

    AstraZeneca

    NICOLE SCHUMACHER-C

    Pfizer

    HARSHA SHETTY

    CSL Behring

    KARTHIK MUTHUSAMY

    Novo Nordisk

    DEANNA MONTES DE OCA

    Moderna

    WENDY ERLER

    Sarepta Therapeutics

    EDDIE DARTON

    Sarepta Therapeutics

    SUSAN WNOROWSKI

    Ipsen

    SHALINI PATEL

    Moderna

    MICHELE COIRO

    Bristol-Myers Squibb

    VASUDEV BHUPATHI

    Moderna

    ALLISON CONCANNON

    Ipsen

    JULIE BARBERIO

    Sanofi

    VIKALP KHARE

    Otsuka Pharmaceutical

    ASHRAF YOUSSEF

    Takeda Pharmaceuticals

    TEODORA DOHERTY

    Janssen R&D

    BEN LOCWIN

    SOPPhC

    MILIND SARDESA

    Dicerna Pharmaceuticals

    SUMIT MUNJAL

    Otsuka Pharmaceutical

    KAL ELHOREGY

    Amneal Pharmaceuticals

    WILLIAM A. BLUMENTALS

    Sanofi

    PRIYANKA CHHIKARA

    CSL Behring

    KAPIL BHUTADA

    Asklepios BioPharmaceutical

    ANUJ PARIKH

    Jazz Pharmaceuticals

    NAMITA JOSHI

    Sanofi

    FATIMA GHETHAN

    Makkah Health Cluster (Saudi Arabia)

    SANDY (BAUTE) DIAZ

    Novo Nordisk

    REEM YASIN

    Hawkary Pharmaceuticals, Kawkab group
    (Iraq)

    HEATHER LEIGH FLANNERY

    AI MINDSystems Foundation

    VINEET SINGH

    CSL Behring

    ×

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      Event Schedule

      Meet to learn and network with your conference colleagues.

      May 27
      May 28
      09:00 - Chairperson opening remarks

      Speaker

      BEN LOCWIN

      VP Board of Directors

      SOPPhC (VP, Reliant Life Sciences)

      09:10 – AI Agents Transforming Safety, Reporting, and Operations

      DATA TO DECISIONS

      • Medical AI Agent for Adverse Event Assessment
      • From Data to Draft: A Proof-of-Concept Agent for AI – Assisted Aggregate Report Writing
      • An AI Agent for Intelligent Navigation of Company Procedures

      Speaker

      PRIYANKA CHHIKARA

      Head of Risk Management, Aggregate Reports & Data

      Science, CSL Behring

      VINEET SINGH

      Head of PV Data Science and Analytics

      CSL Behring

      09:40 – Product safety reviews – purpose & function

      SAFETY

      • What to look for in signal evaluation under new EU guidance
      • Developing drug safety signals for report quality and content
      • Timings for safety review in clinical and post marketed products
      • Validation and confirmation of risk and benefits from signal received
      • Record keeping for safety review meetings

      Speaker

      RUDI SCHEERLINCK

      Safety Strategy Lead – Oncology

      Healthcare Business of Merck

      10:10 – Keynote Panel Discussion: Reimagining Global Pharmacovigilance: From Today’s Challenges to Tomorrow’s Solutions

      CHALLENGES & OPPORTUNITIES

      Moderator

      MARIETTE BOERSTOEL-STREEFLAND

      SVP, Worldwide Patient Safety Officer

      Bristol-Myers Squibb

      Panellists

      PHILISHA MACK

      Sr. Director of Drug Safety, Medical Affairs

      Azurity Pharmaceuticals

      NICOLE SCHUMACHER-CROW

      Continuous Improvement Center of Excellence Head

      – Senior Director, Pfizer

      MILIND SARDESA

      Executive Director, Safety Surveillance, Global

      Patient Safety, Dicerna Pharmaceuticals

      VASUDEV BHUPATHI

      Director – Pharmacovigilance

      Moderna

      NAMITA JOSHI

      Regional PV Head, North America

      Sanofi

      11:00 – Morning Networking Coffee/Tea & Discussion
      11:30 – Real World Data to Real World Evidence

      RWD / RWE

      • Importance of real-world data for answering regulatory 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
      • 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.

      JULIE BARBERIO

      Director, Pharmacoepidemiology

      Sanofi

      12:00 – Solution Provider Presentation

      For sponsorship opportunities please contact
      info.uk@virtueinsight.com

      JULIE BARBERIO

      Director, Pharmacoepidemiology

      Sanofi

      12:30 – Networking luncheon
      13:30 – Panel Discussion - Transforming Pharmacovigilance Through Technology: AI, Automation, and the Future of Drug Safety. Opportunities, Challenges & Lessons Learned

      IMPACT OF TECHNOLOGY

      Moderator

      HEATHER LEIGH FLANNERY

      CEO & Co-Founder

      AI MINDSystems Foundation

      Panellists

      ALTON SARTOR

      Medical Director, Patient Safety Physician Digital &

      Devices, AstraZeneca

      VIKALP KHARE
       
       
      Director, Head of US GPV Safety Data Management
       
       
      Otsuka Pharmaceutical

      PRIYANKA CHHIKARA

      Head of Risk Management, Aggregate Reports &

      Data Science, CSL Behring

      MICHAEL VON FORSTNER

      Chief Scientific Officer

      MedGenie

      CINTHYA GALICIA QUINTANAR

      Senior Manager, Country Safety Lead

      Pfizer

      14:20 – From Compliance to Excellence: The future of Patient Safety

      COMPLIANCE

      • Patient Safety, where are we and what has changed lately?
      • Fundamentals remain unchanged
      • Shift the focus
      • Implementation strategy
      • Conclusion and take aways

      Speaker

      MALIN KREITZ

      Director of European Operations

      Ultragenic Research and Technologies

      14:50 – Gene therapy, long-term follow-up, and Inspection readiness

      GENE THERAPY / INSPECTION

      • Long-term follow-up requirements for Gene therapy
      • How to plan inspection readiness activities for Gene therapy.
      • Risk Management in Gene Therapy

      Speaker

      KAPIL BHUTADA

      Head of PV Safety Operation & Compliance

      Asklepios BioPharmaceutical

      15:20 - Afternoon Networking Coffee/Tea & Discussion
      15:50 – The round table series

      COLLABRATIVE BREAKOUT SESSIONS

      Chairperson for all tables

      Speaker

      BEN LOCWIN

      VP Board of Directors

      SOPPhC (VP, Reliant Life Sciences)

      We have curated 6 distinct roundtable topics, each led by an 2 table speakers. The session is designed for maximum cross-pollination of ideas.

      The Selection: Look at the table numbers and topics listed below. Choose the theme most relevant to your interest.

      The Format: Each table will host a focused, 60-minute deep dive.

      The Flow: Take a seat at your first chosen table. The table speakers will kick off with a brief prompt followed by an open-floor discussion. You have the option to stay put to go deeper or rotate to a different table to gain a new perspective.

      Participation Guidelines

      Lean In: These sessions thrive on your input. If you are comfortable, feel free to discuss on your “work-in-progress” thoughts .

      Keep it Brief: With limited time, aim for “concise contributions” to ensure everyone at the table has a voice.

      Connect: Keep your business cards or digital QR codes ready—these tables are where the best partnerships begin

      Note: Seating is first-come, first-served. If a table is full, we encourage you to explore your second-choice topic—you might find an unexpected insight!

      Table 1 – Technology & Innovation

      Transforming Pharmacovigilance Through Technology: AI, Analytics, and Real-World Evidence

      Speakers

      HEATHER LEIGH FLANNERY

      CEO & Co-Founder

      AI MINDSystems Foundation

      WILLIAM A. BLUMENTALS

      Head of Pharmacoepidemiology, Specialty Care

      Sanofi

      SPEAKER TBC

      Aris Global

      GAYATHRI SUBBURAMAN

      Senior Director, Global Safety Lead

      Menarini Stemline

      Table 2 – Audits & Inspections

      Audit-Ready Pharmacovigilance: Inspection Preparedness, Compliance, and Best Practices

      Speakers

      SHALINI PATEL

      Sr. Director PV Operations – Pharmacovigilance Center of

      Excellence, Moderna

      KAPIL BHUTADA

      Head of PV Safety Operation & Compliance

      Asklepios BioPharmaceutical

      Table 3 – Outsourcing & Collaboration

      Collaborative Pharmacovigilance: Optimizing Partnerships Across Sponsors, CROs, Sites, and Patients

      Speakers

      DEANNA MONTES DE OCA

      Sr. Director, Global Head of PV Operations Case

      Management, Moderna

      SANDY (BAUTE) DIAZ

      Former Executive Director, North America Patient

      Safety Novo Nordisk

      Table 4 – Regulatory Landscape

      Navigating Global PV Regulations: Updates, Expectations, and Future Directions

      Speakers

      Table 5 – Risk Management (RMP / REMS)

      Next-Generation Risk Management: Evolving RMP and REMS Strategies for Patient Safety

      Speakers

      Table 6 – Quality, Safety & Signal Detection

      Ensuring Quality and Safety in PV: Advanced Approaches to Signal Detection and Risk Evaluation

      Speakers

      ASHRAF YOUSSEF

      Global Senior Medical Director, Post Marketed Products, Global Safety Lead

      Takeda Pharmaceuticals

      SANDY (BAUTE) DIAZ

      Former Executive Director, North America Patient Safety

      Novo Nordisk

      16:50 – Closing remarks by chairperson and End of day 01 conference
      17:00 – 18:15 – Networking Drinks
      09:00 - Chairperson opening remarks

      Speaker

      BEN LOCWIN

      VP Board of Directors

      SOPPhC (VP, Reliant Life Sciences)

      09:10 – AI Agents Transforming Safety, Reporting, and Operations

      DATA TO DECISIONS

      • Medical AI Agent for Adverse Event Assessment
      • From Data to Draft: A Proof-of-Concept Agent for AI – Assisted Aggregate Report Writing
      • An AI Agent for Intelligent Navigation of Company Procedures

      Speaker

      PRIYANKA CHHIKARA

      Head of Risk Management, Aggregate Reports & Data

      Science, CSL Behring

      VINEET SINGH

      Head of PV Data Science and Analytics

      CSL Behring

      09:40 – Product safety reviews – purpose & function

      SAFETY

      • What to look for in signal evaluation under new EU guidance
      • Developing drug safety signals for report quality and content
      • Timings for safety review in clinical and post marketed products
      • Validation and confirmation of risk and benefits from signal received
      • Record keeping for safety review meetings

      Speaker

      RUDI SCHEERLINCK

      Safety Strategy Lead – Oncology

      Healthcare Business of Merck

      10:10 – Keynote Panel Discussion: Reimagining Global Pharmacovigilance: From Today’s Challenges to Tomorrow’s Solutions

      CHALLENGES & OPPORTUNITIES

      Moderator

      MARIETTE BOERSTOEL-STREEFLAND

      SVP, Worldwide Patient Safety Officer

      Bristol-Myers Squibb

      Panellists

      PHILISHA MACK

      Sr. Director of Drug Safety, Medical Affairs

      Azurity Pharmaceuticals

      NICOLE SCHUMACHER-CROW

      Continuous Improvement Center of Excellence Head –

      Senior Director, Pfizer

      MILIND SARDESA

      Executive Director, Safety Surveillance, Global Patient

      Safety, Dicerna Pharmaceuticals

      VASUDEV BHUPATHI

      Director – Pharmacovigilance

      Moderna

      NAMITA JOSHI

      Regional PV Head, North America

      Sanofi

      11:00 – Morning Networking Coffee/Tea & Discussion
      11:30 – Real World Data to Real World Evidence

      RWD / RWE

      • Importance of real-world data for answering regulatory 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
      • 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.

      JULIE BARBERIO

      Director, Pharmacoepidemiology

      Sanofi

      12:00 – Solution Provider Presentation

      For sponsorship opportunities please contact
      info.uk@virtueinsight.com

      JULIE BARBERIO

      Director, Pharmacoepidemiology

      Sanofi

      12:30 – Networking luncheon
      13:30 – Panel Discussion - Transforming Pharmacovigilance Through Technology: AI, Automation, and the Future of Drug Safety. Opportunities, Challenges & Lessons Learned

      IMPACT OF TECHNOLOGY

      Moderator

      HEATHER LEIGH FLANNERY

      CEO & Co-Founder

      AI MINDSystems Foundation

      Panellists

      ALTON SARTOR

      Medical Director, Patient Safety Physician Digital &

      Devices, AstraZeneca

      VIKALP KHARE
       
       
      Director, Head of US GPV Safety Data Management
       
       
      Otsuka Pharmaceutical

      PRIYANKA CHHIKARA

      Head of Risk Management, Aggregate Reports & Data

      Science, CSL Behring

      MICHAEL VON FORSTNER

      Chief Scientific Officer

      MedGenie

      CINTHYA GALICIA QUINTANAR

      Senior Manager, Country Safety Lead

      Pfizer

      14:20 – From Compliance to Excellence: The future of Patient Safety

      COMPLIANCE

      • Patient Safety, where are we and what has changed lately?
      • Fundamentals remain unchanged
      • Shift the focus
      • Implementation strategy
      • Conclusion and take aways

      Speaker

      MALIN KREITZ

      Director of European Operations

      Ultragenic Research and Technologies

      14:50 – Gene therapy, long-term follow-up, and Inspection readiness

      GENE THERAPY / INSPECTION

      • Long-term follow-up requirements for Gene therapy
      • How to plan inspection readiness activities for Gene therapy.
      • Risk Management in Gene Therapy

      Speaker

      KAPIL BHUTADA

      Head of PV Safety Operation & Compliance

      Asklepios BioPharmaceutical

      15:20 - Afternoon Networking Coffee/Tea & Discussion
      15:50 – The round table series

      COLLABRATIVE BREAKOUT SESSIONS

      Chairperson for all tables

      Speaker

      BEN LOCWIN

      VP Board of Directors

      SOPPhC (VP, Reliant Life Sciences)

      We have curated 6 distinct roundtable topics, each led by an 2 table speakers. The session is designed for maximum cross-pollination of ideas.

      The Selection: Look at the table numbers and topics listed below. Choose the theme most relevant to your interest.

      The Format: Each table will host a focused, 60-minute deep dive.

      The Flow: Take a seat at your first chosen table. The table speakers will kick off with a brief prompt followed by an open-floor discussion. You have the option to stay put to go deeper or rotate to a different table to gain a new perspective.

      Participation Guidelines

      Lean In: These sessions thrive on your input. If you are comfortable, feel free to discuss on your “work-in-progress” thoughts .

      Keep it Brief: With limited time, aim for “concise contributions” to ensure everyone at the table has a voice.

      Connect: Keep your business cards or digital QR codes ready—these tables are where the best partnerships begin

      Note: Seating is first-come, first-served. If a table is full, we encourage you to explore your second-choice topic—you might find an unexpected insight!

      Table 1 – Technology & Innovation

      Transforming Pharmacovigilance Through Technology: AI, Analytics, and Real-World Evidence

      Speakers

      HEATHER LEIGH FLANNERY

      CEO & Co-Founder

      AI MINDSystems Foundation

      WILLIAM A. BLUMENTALS

      Head of Pharmacoepidemiology, Specialty Care

      Sanofi

      SPEAKER TBC

      Aris Global

      GAYATHRI SUBBURAMAN

      Senior Director, Global Safety Lead

      Menarini Stemline

      Table 2 – Audits & Inspections

      Audit-Ready Pharmacovigilance: Inspection Preparedness, Compliance, and Best Practices

      Speakers

      KAPIL BHUTADA

      Head of PV Safety Operation & Compliance

      Asklepios BioPharmaceutical

      SHALINI PATEL


      Sr. Director PV Operations – Pharmacovigilance Center of

      Excellence, Moderna

      Table 3 – Outsourcing & Collaboration

      Collaborative Pharmacovigilance: Optimizing Partnerships Across Sponsors, CROs, Sites, and Patients

      Speakers

      DEANNA MONTES DE OCA

      Sr. Director, Global Head of PV Operations Case

      Management, Moderna

      SANDY (BAUTE) DIAZ

      Former Executive Director, North America Patient Safety

      Novo Nordisk

      Table 4 – Regulatory Landscape

      Navigating Global PV Regulations: Updates, Expectations, and Future Directions

      Speakers

      Table 5 – Risk Management (RMP / REMS)

      Next-Generation Risk Management: Evolving RMP and REMS Strategies for Patient Safety

      Speakers

      Table 6 – Quality, Safety & Signal Detection

      Ensuring Quality and Safety in PV: Advanced Approaches to Signal Detection and Risk Evaluation

      Speakers

      ASHRAF YOUSSEF


      Global Senior Medical Director, Post Marketed Products, Global

      Safety Lead, Takeda Pharmaceuticals

      SANDY (BAUTE) DIAZ

      Former Executive Director, North America Patient Safety

      Novo Nordisk

      16:50 – Closing remarks by chairperson and End of day 01 conference
      17:00 – 18:15 – Networking Drinks
      09:00 - Chairperson opening remarks

      Speaker

      BEN LOCWIN

      VP Board of Directors

      SOPPhC (VP, Reliant Life Sciences)

      09:10 – Pharmacovigilance with Patients at the Forefront of Drug Safety and Trust

      PRIORITISING PATIENTS

      • How does the pharma industry approach rigorous pharmacovigilance and safety frameworks and reporting
      • What are the public facing safety databases and what are they not (i.e. FAERS)
      • How to approach the next generation of drug safety from a truly patient centric perspective

      Speaker

      WENDY ERLER

      SVP Patient Affairs

      Sarepta Therapeutics

      EDDIE DARTON

      VP – Head Global PV & Risk Management

      Sarepta Therapeutics

       

      09:50 – Enhancing Quality and Patient Safety Through Pharmacovigilance, Document Control & Policy Governance Integration

      SAFETY

      • What to look for in signal evaluation under new EU guidance
      • Developing drug safety signals for report quality and content
      • Timings for safety review in clinical and post marketed products
      • Validation and confirmation of risk and benefits from signal received
      • Record keeping for safety review meetings

      Speaker

      FATIMA GHETHAN

      Document Control at Executive administration of Quality & Performance

      Makkah Health Cluster (Saudi Arabia)

      10:20 – Keynote Panel Discussion: Patient-Centric Pharmacovigilance: Shaping the Next Generation of Drug Safety. A New Era of Safety and Trust

      PATIENT SAFETY

      Moderator

      ANUJ PARIKH

      Associate Medical Director, Medical Safety

      Jazz Pharmaceuticals

      Panellists

      HARSHA SHETTY

      Senior Director, Global Safety Lead & Patient Engagement

      CSL Behring

      SUSAN WNOROWSKI

      Sr. Director, US Medical Information and Patient Safety

      Ipsen

      KARTHIK MUTHUSAMY

      Executive Director, Head of US Patient Safety

      Novo Nordisk

      TEODORA DOHERTY

      Global Medical Safety (GMS), Medical Safety Officer

      Janssen R&D

      FATIMA GHETHAN

      Document Control at Executive administration of Quality &

      Performance, Makkah Health Cluster (Saudi Arabia)

      11:10 – Morning Networking Coffee/Tea & Discussion
      11:30 – Adverse Drug Reactions (ADRs) in Special Populations: Women and Children
      • Overview of physiological and pharmacokinetic differences in women and pediatric populations that influence ADR risk
      • Common and serious ADR patterns observed in women (e.g., pregnancy, lactation, hormonal factors) and children (e.g., growth and developmental stages)
      • Key challenges in detection, reporting, and assessment of ADRs in these special populations
      • Strategies to enhance medication safety through tailored prescribing, monitoring, and pharmacovigilance practices

      REEM YASIN

      Quality Assurance & PV Manager

      Hawkary Pharmaceuticals, Kawkab group (Iraq)

      12:00 – Solution Provider Presentation

      For sponsorship opportunities please contact
      info.uk@virtueinsight.com

      JULIE BARBERIO

      Director, Pharmacoepidemiology

      Sanofi

      12:30 – Networking luncheon
      13:30 – Panel Discussion - From RMPs to REMS: Implementing Effective Next-Generation Risk Management Strategies. Practical Approaches for Modern PV Systems

      RISK MANAGEMENT & PLANNING

      Moderator

      KAL ELHOREGY

      Director, Risk Evaluation and Mitigation Strategy (REMS) Programs

      Amneal Pharmaceuticals

      Panellists

      MICHELE COIRO

      Director, US REMS Strategy & Submissions

      Bristol-Myers Squibb

      ALLISON CONCANNON

      Director, Global Patient Safety, Americas Lead

      Ipsen

      SUMIT MUNJAL
       

      Global Head of Medical Safety
       
       
      Otsuka Pharmaceutical

      REEM YASIN

      Quality Assurance & PV Manager

      Hawkary Pharmaceuticals, Kawkab group (Iraq)

      MICHAEL VON FORSTNER

      Chief Scientific Officer

      MedGenie

      CINTHYA GALICIA QUINTANAR

      Senior Manager, Country Safety Lead

      Pfizer

      14:20 – Panel Discussion: Regulatory Pathways to Patient Safety: How Regulatory Changes Are Reshaping PV?. What’s Next in PV Regulations? Trends, Updates, and the Road Ahead

      REGULATORY UPDATE

      Moderator

      BEN LOCWIN

      VP Board of Directors

      SOPPhC (VP, Reliant Life Sciences)

      Panellists

      ALTON SARTOR

      Medical Director, Patient Safety Physician Digital &

      Devices, AstraZeneca

      VIKALP KHARE
       
       
      Director, Head of US GPV Safety Data Management
       
       
      Otsuka Pharmaceutical

      PRIYANKA CHHIKARA

      Head of Risk Management, Aggregate Reports & Data

      Science, CSL Behring

      MICHAEL VON FORSTNER

      Chief Scientific Officer

      MedGenie

      CINTHYA GALICIA QUINTANAR

      Senior Manager, Country Safety Lead

      Pfizer

      15:00 - Afternoon Networking Tea/Coffee & End of conference
      09:00 - Chairperson opening remarks

      Speaker

      BEN LOCWIN

      VP Board of Directors

      SOPPhC (VP, Reliant Life Sciences)

      09:10 – Pharmacovigilance with Patients at the Forefront of Drug Safety and Trust

      PRIORITISING PATIENTS

      • How does the pharma industry approach rigorous pharmacovigilance and safety frameworks and reporting
      • What are the public facing safety databases and what are they not (i.e. FAERS)
      • How to approach the next generation of drug safety from a truly patient centric perspective

      Speaker

      WENDY ERLER

      SVP Patient Affairs

      Sarepta Therapeutics

      EDDIE DARTON

      VP – Head Global PV & Risk Management

      Sarepta Therapeutics

       

      09:50 – Enhancing Quality and Patient Safety Through Pharmacovigilance, Document Control & Policy Governance Integration

      SAFETY

      • What to look for in signal evaluation under new EU guidance
      • Developing drug safety signals for report quality and content
      • Timings for safety review in clinical and post marketed products
      • Validation and confirmation of risk and benefits from signal received
      • Record keeping for safety review meetings

      Speaker

      FATIMA GHETHAN

      Document Control at Executive administration of Quality & Performance

      Makkah Health Cluster (Saudi Arabia)

      10:20 – Keynote Panel Discussion: Patient-Centric Pharmacovigilance: Shaping the Next Generation of Drug Safety. A New Era of Safety and Trust

      PATIENT SAFETY

      Moderator

      ANUJ PARIKH

      Associate Medical Director, Medical Safety

      Jazz Pharmaceuticals

      Panellists

      HARSHA SHETTY

      Senior Director, Global Safety Lead & Patient Engagement

      CSL Behring

      SUSAN WNOROWSKI

      Sr. Director, US Medical Information and Patient Safety

      Ipsen

      KARTHIK MUTHUSAMY

      Executive Director, Head of US Patient Safety

      Novo Nordisk

      TEODORA DOHERTY

      Global Medical Safety (GMS), Medical Safety Officer

      Janssen R&D

      FATIMA GHETHAN

      Document Control at Executive administration of Quality &

      Performance, Makkah Health Cluster (Saudi Arabia)

      11:10 – Morning Networking Coffee/Tea & Discussion
      11:30 – Adverse Drug Reactions (ADRs) in Special Populations: Women and Children
      • Overview of physiological and pharmacokinetic differences in women and pediatric populations that influence ADR risk
      • Common and serious ADR patterns observed in women (e.g., pregnancy, lactation, hormonal factors) and children (e.g., growth and developmental stages)
      • Key challenges in detection, reporting, and assessment of ADRs in these special populations
      • Strategies to enhance medication safety through tailored prescribing, monitoring, and pharmacovigilance practices

      REEM YASIN

      Quality Assurance & PV Manager

      Hawkary Pharmaceuticals, Kawkab group (Iraq)

      12:00 – Solution Provider Presentation

      For sponsorship opportunities please contact
      info.uk@virtueinsight.com

      JULIE BARBERIO

      Director, Pharmacoepidemiology

      Sanofi

      12:30 – Networking luncheon
      13:30 – Panel Discussion - From RMPs to REMS: Implementing Effective Next-Generation Risk Management Strategies. Practical Approaches for Modern PV Systems

      RISK MANAGEMENT & PLANNING

      Moderator

      KAL ELHOREGY

      Director, Risk Evaluation and Mitigation Strategy (REMS) Programs

      Amneal Pharmaceuticals

      Panellists

      MICHELE COIRO

      Director, US REMS Strategy & Submissions

      Bristol-Myers Squibb

      ALLISON CONCANNON

      Director, Global Patient Safety, Americas Lead

      Ipsen

      SUMIT MUNJAL
       

      Global Head of Medical Safety
       
       
      Otsuka Pharmaceutical

      REEM YASIN

      Quality Assurance & PV Manager

      Hawkary Pharmaceuticals, Kawkab group (Iraq)

      MICHAEL VON FORSTNER

      Chief Scientific Officer

      MedGenie

      CINTHYA GALICIA QUINTANAR

      Senior Manager, Country Safety Lead

      Pfizer

      14:20 – Panel Discussion: Regulatory Pathways to Patient Safety: How Regulatory Changes Are Reshaping PV?. What’s Next in PV Regulations? Trends, Updates, and the Road Ahead

      REGULATORY UPDATE

      Moderator

      BEN LOCWIN

      VP Board of Directors

      SOPPhC (VP, Reliant Life Sciences)

      Panellists

      ALTON SARTOR

      Medical Director, Patient Safety Physician Digital &

      Devices, AstraZeneca

      VIKALP KHARE
       
       
      Director, Head of US GPV Safety Data Management
       
       
      Otsuka Pharmaceutical

      PRIYANKA CHHIKARA

      Head of Risk Management, Aggregate Reports & Data

      Science, CSL Behring

      MICHAEL VON FORSTNER

      Chief Scientific Officer

      MedGenie

      CINTHYA GALICIA QUINTANAR

      Senior Manager, Country Safety Lead

      Pfizer

      15:00 - Afternoon Networking Tea/Coffee & End of conference
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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!

        Platinum Sponsor 

        ArisGlobals LifeSphere Safety offers the only unified, next-generation SaaS Safety platform in production, built to enable touchless case processing, scalable compliance, and standardized global pharmacovigilance workflows. Drive transformative change with industry-leading capabilities, including the latest innovations in automation, analytics, and GenAI technologies powered by LifeSphere NavaX.

        Bronze Sponsor 

        4C Pharma Solutions is established and operated by Physicians and Subject Matter Experts experienced in Clinical Research, Pharmacovigilance and Regulatory Affairs. It is one of the fastest growing global service provider organizations headquartered in the United States. The service spectrum spans Pharmacovigilance/Drug Safety, Devices, Biologics, Consumer Care products, Nutraceuticals & Cannabis products, Regulatory Affairs, Medical Writing, Argus Safety Database Hosting, Maintenance, Support and Training. 4C is focused on delivering quality services at an optimized cost to suit clients’ budget. We are ISO 9001 and 27001 certified with fully validated in-house Oracle Argus Safety installed on cloud for quick deployment and high availability. We provide quality support for Argus at drastically reduced costs facilitating companies to focus on R&D and other tasks without extensive technology overheads. We have an exemplary team of healthcare and IT professionals, well-established facilities, processes and systems capable of providing end to end support in Dossiers (CTD/eCTD/NeeS) preparation, publishing, validation, submissions, Labeling, Artworks, Medical Information Call Center, Literature Search, Case Processing, Signal Detection, Aggregate Reports, Risk Management Plans, Pharmacovigilance SOPs preparation, System setup and Training. 4C team also has expertise on multiple safety and regulatory applications to accommodate any requirement.

        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.
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        Event Testimonials

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

        Insightful Session

        “Thank you Siddhaarth! You and the team did an outstanding job once again! Appreciate everything Virtue Insight does to promote PV. Excellent speakers and panels”

        Head, Business Development US, Qinecsa Solutions
        Great Event

        “Thank you for a great conference. What a pleasant surprise to win the mini”

        Director, Global Pharmacovigilance & Epidemiology, Bristol-Myers Squibb

        “I enjoyed the venue (Waltham Conference Center), and think it would be a good fit for a meeting of this size. ”

        Sr. Director, Head of Pharmacoepidemiology, Sanofi

        “A huge compliment to the organizers! The event was very well researched and organized. The speakers represented leading organizations and addressed the most recent questions in the field, providing insights in current developments and meaningful solution approaches. The conference provided excellent opportunities to discuss recent developments with top experts and build impactful professional relationships. Overall, the conference was very useful and a joy to attend, also due to the selection of an easy to reach venue in an environment of biomedical research excellence and quality.”

        Director, Merck

          Booking Details

          We are currently in process of moving our payment gateway. Our online booking option will be coming soon. In the mean time please use below secure payment link to confirm your participation.

          Super Early Bird Price (Valid till 27 March)

          For 1 Delegate – $899

          Secure Payment Link

          Group Discount – $1798 (3 Delegates for the price of 2)

          Secure Payment Link

          Venue details

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

           

          Venue

          Boston

           USA

          13869 Park Center Rd,

          Herndon, VA 20171,

          United States

          +1 703-478-2900

           

          Venue – Boston, USA

          13869 Park Center Rd,

          Herndon, VA 20171,

          United States

          +1 703-478-2900

          Get Involved

          Conference Production

          Conference Production

          Fen Castro
          fen@virtueinsightevents.com
          +91 44 42108101
          Sponsorship & Delegate Sales

          Sponsorship & Delegate Sales

          Piyush Patel
          piyush@virtueinsightevents.com
          +44 20 3509 3779
          #VIphv202641stannualpharmaPharmacovigilanceUSA
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