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Conference Overview
Pharmacovigilance USA 2026: Core Focus Areas
“As the pharmacovigilance landscape shifts toward an AI-integrated future, staying ahead of regulatory and technological curves is critical. Our 2026 agenda is strategically designed to address the core pillars of modern drug safety, providing you with actionable blueprints for excellence.”
From Compliance to Intelligence
Move beyond traditional reporting toward a predictive, AI-driven pharmacovigilance model that anticipates risks before they emerge.
AI & Automation in Action
Explore how AI Agents are transforming safety operations, from medical assessment to assisted aggregate report writing.
Regulatory Mastery
Engage directly on evolving global requirements, including EMA’s Post Authorization Safety Studies and modern RMP/REMS strategies.
Real-World Evidence (RWE)
Learn how to harness RWD to answer critical regulatory questions and improve structured benefit-risk assessments.
Patient-Centric Safety
Shift the focus to the next generation of drug safety by integrating the patient voice and fostering trust across the healthcare ecosystem.
Advanced Signal Detection
Discover cutting-edge methodologies for quality and signal detection to ensure robust safety surveillance in an increasingly complex data landscape.
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The Global Standard in Drug Safety Excellence
Building on a prestigious legacy of 40 successful global summits, the 41st Pharmacovigilance USA 2026 arrives at a critical turning point for the industry. With the global drug safety software market projected to exceed $350M by 2030, the shift toward digital transformation and AI-driven reporting is no longer optional—it is a regulatory requirement.
This year, we unite a high-level ecosystem of Pharmaceutical, Biotech, and Regulatory stakeholders in Boston to dismantle silos and solve the most pressing challenges in the drug safety value chain. From navigating stringent EMA updates to mastering automation in PV, this forum provides the strategic intelligence and cross-functional collaboration needed to thrive in an increasingly complex global landscape.
Speakers
Attendees
round tables
Hours of High Value Networking
OUR ATTENDEES
Trusted by Industry Leaders Worldwide
REGISTER ATTEND LEARN NETWORK SUCCEED
5 reasons to attend the events
"In an era of rapid digital transformation and tightening global regulations, staying informed is no longer enough—you need a blueprint for action. Here is why the 41st Pharmacovigilance USA summit is the must-attend event for drug safety leaders in 2026."
Learn from the Elite
Access exclusive insights from senior leaders at Pfizer, Moderna, BMS, and GSK.
Master AI Innovation
Gain a technical edge with deep dives into AI Agents and Automation transforming PV operations.
Navigate Global Regulations
Stay compliant with expert-led sessions on the latest RMP, REMS, and EMA requirements.
Solve Real-World Challenges
Move beyond passive listening with interactive Roundtable Series designed for peer-to-peer problem-solving.
Elite Networking
Build high-value partnerships with a niche global audience in the heart of the Boston
Meet Our Expert Speakers
OUR EVENT SCHEDULE
08:50 - Chairperson opening remarks
BEN LOCWIN
SOPPhC (VP, Reliant Life Sciences)
09:20 – Welcome Address & Opening Remarks
DATA TO DECISIONS
09:00 – AI Agents Transforming Safety, Reporting, and Operations
- 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
PRIYANKA CHHIKARA
CSL Behring
VINEET SINGH
CSL Behring
09:30 – Agentic AI in Pharmacovigilance: From Task Automation to Unified Data Intelligence
This session examines the structural shift in pharmacovigilance from task automation toward bounded, coordinated agentic systems operating on unified data and knowledge foundations. Drawing on emerging architectural
patterns, it outlines howdecision intelligence elevates insight, context, and cross functional coherence across safety and regulatory domains.
JASON BRYANT
ArisGlobal
CHALLENGES & OPPORTUNITIES
10:00 – Keynote Panel Discussion: Reimagining Global Pharmacovigilance: From Today’s Challenges to Tomorrow’s Solutions
Moderator
MARIETTE BOERSTOEL-STREEFLAND
Bristol-Myers Squibb
Panellists
PHILISHA MACK
Azurity Pharmaceuticals
NICOLE SCHUMACHER-CROW
Pfizer
VASUDEV BHUPATHI
Moderna
NAMITA JOSHI
Opella
10:50 – Morning Networking Coffee/Tea & Discussion
RWD / RWE
11:20 – Real World Data to Real World Evidence
- 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
Sanofi
PV IN GENE THERAPHY
11:50 – Gene therapy long-term safety management
- 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.
MALLIKA SINGH
Genetix Biotherapeutics
12:20 – Topic TBC
- 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.
HUMAIRA QURESHI
Arriello
12:40 – Networking luncheon
IMPACT OF TECHNOLOGY
13:40 – Panel Discussion - Transforming Pharmacovigilance Through Technology: AI, Automation, and the Future of Drug Safety. Opportunities, Challenges & Lessons Learned
Moderator
HEATHER LEIGH FLANNERY
AI MINDSystems Foundation
Panellists
ALTON SARTOR
AstraZeneca
VIKALP KHARE
Otsuka Pharmaceutical
MICHAEL GLASER
GSK
PRIYANKA CHHIKARA
CSL Behring
YILONG JIA
Sumitomo Pharma America
14:40 – Accelerate Signal and Risk Management with Unified Safety
- Discover how a unified safety solution removes data silos to accelerate data flow, enabling earlier signal detection and seamless traceability to source case data
- Streamline the development and oversight of risk management plans (RMPs) and additional risk minimization measures (aRMMs) by directly linking them to signal outcomes
- Improve global-to-local oversight by ensuring consistent signal tracking and risk implementation across regions
- Explore how signal and risk management on a single platform provides deeper analytical insights and reduces compliance risks
CHRISTINA KIM
Veeva Systems
GENE THERAPY / INSPECTION
15:00 – Gene therapy, long-term follow-up, and Inspection readiness
- Long-term follow-up requirements for Gene therapy
- How to plan inspection readiness activities for Gene therapy.
- Risk Management in Gene Therapy
KAPIL BHUTADA
Asklepios BioPharmaceutical
15:20 – Afternoon Networking Coffee/Tea & Discussion
COLLABRATIVE BREAKOUT SESSIONS
16:00 – The round table series
Chairperson for all tables
BEN LOCWIN
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
HEATHER LEIGH FLANNERY
AI MINDSystems Foundation
JASON BRYANT
ArisGlobal
Table 2 – Audits & Inspections
Audit-Ready Pharmacovigilance: Inspection Preparedness, Compliance, and Best Practices
SHALINI PATEL
Moderna
KAPIL BHUTADA
Asklepios BioPharmaceutical
Table 3 – Outsourcing & Collaboration
Collaborative Pharmacovigilance: Optimizing Partnerships Across Sponsors, CROs, Sites, and Patients
DEANNA MONTES DE OCA
Moderna
HUMAIRA QURESHI
Arriello
SANDY DIAZ
Pharmacovigilance Solutions
Table 4 – Regulatory Landscape
Navigating Global PV Regulations: Updates, Expectations, and Future Directions
NITHILA DURAISAMY
Nevakar
HEIDI GERTNER
Hogan Lovells
Table 5 – Risk Management (RMP / REMS)
Next-Generation Risk Management: Evolving RMP and REMS Strategies for Patient Safety
MANJIRI NIRGUDKAR
Bristol-Myers Squibb
JILLIAN HORVATH
Jazz Pharmaceuticals
Table 6 – Quality, Safety & Signal Detection
Ensuring Quality and Safety in PV: Advanced Approaches to Signal Detection and Risk Evaluation
ASHRAF YOUSSEF
Takeda Pharmaceuticals
JIAN-YU E
Sanofi
Table 7 – RWD / RWE
Harnessing RWD & RWE: Transforming the Future of Pharmacovigilance
WILLIAM A. BLUMENTALS
Sanofi
WILLIAM A. BLUMENTALS
Sanofi
14:50 - Re-imagining Dossier Authoring: From Manual Compilation to AI-Assisted Authoring and Lifecycle Management
- AI-driven automation in dossier creation: Transition from time-consuming manual compilation to intelligent automation where AI tools structure, draft, and validate regulatory dossiers using pre-designed templates as per ICH guidelines and real-time data processing.
- Enhanced compliance and efficiency: AI-assisted authoring ensures alignment with global regulatory standards (e.g., EMA, USFDA, CDSCO) by auto-updating changes in guidance and improving accuracy, traceability, and submission timelines.
- Lifecycle intelligence and version management: Integrating AI into the dossier lifecycle enables continuous monitoring, smart version control, and predictive updates across product changes, fostering a fully connected regulatory ecosystem.
MANASA KASIVAJJULA
CEO and Co-Founder
DeepForrest.ai (A CtrlS Company)
17:00 – Closing remarks by chairperson and End of day 01
conference
17:10 – Networking Drinks
08:50 - Chairperson opening remarks
BEN LOCWIN
SOPPhC (VP, Reliant Life Sciences)
09:20 – Welcome Address & Opening Remarks
PRIORITISING PATIENTS
09:00 – Pharmacovigilance with Patients at the Forefront of Drug Safety and Trust
- 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
WENDY ERLER
Sarepta Therapeutics
EDDIE DARTON
Sarepta Therapeutics
09:30 – Topic TBC
This session examines the structural shift in pharmacovigilance from task automation toward bounded, coordinated agentic systems operating on unified data and knowledge foundations. Drawing on emerging architectural
patterns, it outlines howdecision intelligence elevates insight, context, and cross functional coherence across safety and regulatory domains.
AMIT JAIN
Ultragenic Research and Technologies
PATIENT SAFETY
10:00 – Keynote Panel Discussion: Patient-Centric Pharmacovigilance: Shaping the Next Generation of Drug Safety. A New Era of Safety and Trust
Moderator
BEN LOCWIN
SOPPhC (VP, Reliant Life Sciences)
Panellists
HARSHA SHETTY
CSL Behring
KARTHIK MUTHUSAMY
Novo Nordisk
TEODORA DOHERTY
Janssen R&D
HEIDI GERTNER
Hogan Lovells
10:50 – Morning Networking Coffee/Tea & Discussion
11:20 – Compliance to regulations related to EMA’s Post Authorization Safety Studies
- 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.
SHEFALI JOBANPUTRA
Takeda
11:50 – How can you run drug safety as a real-time, AI-driven system?
- Building agentic capabilities: autonomous workflows
- Expand data and own semantic layer
- Speed and embedded governance
NICOLE BAKER
Biologit
12:20 – Networking luncheon
13:20 – Strategic Risk Management in Pharmacovigilance: Driving Patient Safety Through RMP and REMS
- 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.
SANJEEV MIGLANI
AWINSA Life Sciences
13:30 – Ensuring Compliance in DSUR Processes: Addressing Global Regulatory Complexities
- 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.
MUGDHA CHOPRA
AWINSA Life Sciences
13:40 – EU GVP update Aug 2025: requirements about audit of third party. How to mitigate the risk during inspection ?
- 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.
JOHN ELZER
Sanofi
RISK MANAGEMENT & PLANNING
14:20 – Panel Discussion - From RMPs to REMS: Implementing Effective Next-Generation Risk Management Strategies. Practical Approaches for Modern PV Systems
Moderator
KAL ELHOREGY
Amneal Pharmaceuticals
Panellists
MICHELE COIRO
Bristol-Myers Squibb
ALLISON CONCANNON
Ipsen
NINA TEO
Alnylam Pharmaceuticals
NINA TEO
Alnylam Pharmaceuticals
15:10 – Chairperson closing remarks / Afternoon
Networking Tea/Coffee & End of conference
OUR EVENT SCHEDULE
08:50 - Chairperson opening remarks
BEN LOCWIN
VP Board of Directors
SOPPhC (VP, Reliant Life Sciences)
DATA TO DECISIONS
09:00 – AI Agents Transforming Safety, Reporting, and Operations
- 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
PRIYANKA CHHIKARA
Head of Risk Management, Aggregate Reports & Data Science, CSL Behring
VINEET SINGH
PV Data Science Lead, CSL Behring
09:30 – Agentic AI in Pharmacovigilance: From Task Automation to Unified Data Intelligence
This session examines the structural shift in pharmacovigilance from task automation toward bounded, coordinated agentic systems operating on unified data and knowledge foundations. Drawing on emerging architectural patterns, it outlines howdecision intelligence elevates insight, context, and cross functional coherence across safety and regulatory domains.
JASON BRYANT
SVP, Product Management, AI
ArisGlobal
CHALLENGES & OPPORTUNITIES
10:00 – Keynote Panel Discussion: Reimagining Global Pharmacovigilance: From Today’s Challenges to Tomorrow’s Solutions
Moderator:
MARIETTE BOERSTOEL-STREEFLAND
SVP, Worldwide Patient Safety Officer
Bristol-Myers Squibb
Panellists:
PHILISHA MACK
VP, Global Drug Safety,
Azurity Pharmaceuticals
NICOLE SCHUMACHER-CROW
Continuous Improvement Center of Excellence
Head -Senior Director, Pfizer
VASUDEV BHUPATHI
Director – Pharmacovigilance
Moderna
NAMITA JOSHI
Regional PV Head, North America
Sanofi
10:50 – Morning Networking Coffee/Tea & Discussion
RWD / RWE
11:20 – Real World Data to Real World Evidence
- 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
PV IN GENE THERAPHY
11:50 – Gene therapy long-term safety management
MALLIKA SINGH
Associate Director, Pharmacovigilance
Genetix Biotherapeutics
12:00 – Solution Provider Presentation
For sponsorship opportunities please contact
info.uk@virtueinsight.com
PV IN GENE THERAPHY
12:20 – Topic TBC
HUMAIRA QURESHI
Chief Operating Officer
Arriello
12:00 – Solution Provider Presentation
For sponsorship opportunities please contact
info.uk@virtueinsight.com
12:40 – Networking luncheon
IMPACT OF TECHNOLOGY
13:40 – Panel Discussion - Transforming Pharmacovigilance Through Technology: AI, Automation, and the Future of Drug Safety. Opportunities, Challenges & Lessons Learned
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
MICHAEL GLASER
Technology Innovation Director
GSK
PRIYANKA CHHIKARA
Head of Risk Management, Aggregate Reports & Data Science,
CSL Behring
YILONG JIA
Sr. Manager Pharmacovigilance Informatics,
Sumitomo Pharma America
14:40 – Accelerate Signal and Risk Management with Unified Safety
- Discover how a unified safety solution removes data silos to accelerate data flow, enabling earlier signal detection and seamless traceability to source case data
- Streamline the development and oversight of risk management plans (RMPs) and additional risk minimization measures (aRMMs) by directly linking them to signal outcomes
- Improve global-to-local oversight by ensuring consistent signal tracking and risk implementation across regions
- Explore how signal and risk management on a single platform provides deeper analytical insights and reduces compliance risks
CHRISTINA KIM
Senior Director, Veeva Safety
Veeva Systems
GENE THERAPY / INSPECTION
15:00 – Gene therapy, long-term follow-up, and Inspection readiness
- Long-term follow-up requirements for Gene therapy
- How to plan inspection readiness activities for Genetherapy.
- Risk Management in Gene Therapy
KAPIL BHUTADA
Head of PV Safety Operation & Compliance
Asklepios BioPharmaceutical
15:20 – Afternoon Networking Coffee/Tea & Discussion
COLLABRATIVE BREAKOUT SESSIONS
16:00 – The round table series
Chairperson for all tables
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 a 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
SPEAKER TBC
Aris Global
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
HUMAIRA QURESHI
Chief Operating Officer, Arriello
SANDY DIAZ
Owner & Principal Consultant Pharmacovigilance Solutions
Table 4 – Regulatory Landscape
Navigating Global PV Regulations: Updates, Expectations and Future Directionss
Speakers
NITHILA DURAISAMY
VP - Head of Regulatory Affairs Nevakar
HEIDI GERTNER
Partner, Hogan Lovells
Table 5 – Risk Management (RMP / REMS)
Next-Generation Risk Management: Evolving RMP and REMS Strategies for Patient Safety
Speaker
MANJIRI NIRGUDKAR
Director; Global Process Lead - Global Risk Management Bristol-Myers Squibb
JILLIAN HORVATH
Associate Director, Global RMP (Pharmacovigilance) Jazz Pharmaceuticals
Table 6 – Quality, Safety & Signal Detection
Ensuring Quality and Safety in PV: Advanced Approaches toSignal Detection and Risk Evaluation
Speakers
ASHRAF YOUSSEF
Global Senior Medical Director, Post Marketed Products, Global Safety Lead, Takeda Pharmaceuticals
JIAN-YU E
Director of Pharmacoepidemiology, Patient Safety & PV (PSPV), Sanofi
Table 7 – RWD / RWE
Harnessing RWD & RWE: Transforming the Future of Pharmacovigilance
Speaker
WILLIAM A. BLUMENTALS
Head of Pharmacoepidemiology, Specialty Care Sanofi
17:00 – Closing remarks by chairperson and End of day 01 conference
17:10 – Networking Drinks
08:50 – Chairperson opening remarks
BEN LOCWIN
VP Board of Directors
SOPPhC (VP, Reliant Life Sciences)
PRIORITISING PATIENTS
09:00 – Pharmacovigilance with Patients at the Forefront of Drug Safety and Trust
- 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
WENDY ERLER
SVP Patient Affairs Sarepta Therapeutics
EDDIE DARTON
VP - Head Global PV & Risk Management Sarepta Therapeutics
09:30 – Topic TBC
AMIT JAIN
Founder and Director US Ops, Ultragenic Research and Technologies
PATIENT SAFETY
10:00 – Keynote Panel Discussion: Patient-Centric Pharmacovigilance: Shaping the Next Generation of Drug Safety. A New Era of Safety and Trust
Moderator:
BEN LOCWIN
VP Board of Directors, SOPPhC (VP, Reliant Life Sciences)
Panellists:
HARSHA SHETTY
Senior Director, Global Safety Lead & Patient Engagement CSL Behring
KARTHIK MUTHUSAMY
Executive Director, Head of US Patient Safety Novo Nordisk
TEODORA DOHERTY
Global Medical Safety (GMS), Medical Safety Officer Janssen R&D
HEIDI GERTNER
Partner, Hogan Lovells
10:50 – Morning Networking Coffee/Tea & Discussion
11:20 - Compliance to regulations related to EMA’s Post Authorization Safety Studies
SHEFALI JOBANPUTRA
Associate Director, CPASS Compliance, Process, and Training Lead, Takeda
11:50 - Topic TBC
NICOLE BAKER
CEO, Biologit
12:20 – Networking luncheon
13:20 – Strategic Risk Management in Pharmacovigilance: Driving Patient Safety Through RMP and REMS
- Key Use Cases of Automation in Pharmacovigilance
- Robotic process automation (RPA), AI, Machine Learning
- Which areas of PV are you most likely to automate?
- Cognitive Computing in Pharmacovigilance: RevampingDrug Safety Using an Advanced Computing System
- Building an Automation-Centric Approach to Drug Safety
SANJEEV MIGLANI
Founder & Director, AWINSA Life Sciences
13:30 – Ensuring Compliance in DSUR Processes: Addressing Global Regulatory Complexities
- Key Use Cases of Automation in Pharmacovigilance
- Robotic process automation (RPA), AI, Machine Learning
- Which areas of PV are you most likely to automate?
- Cognitive Computing in Pharmacovigilance: RevampingDrug Safety Using an Advanced Computing System
- Building an Automation-Centric Approach to Drug Safety
MUGDHA CHOPRA
Co-founder & Director, AWINSA Life Sciences
13:40 – EU GVP update Aug 2025: requirements about audit of third party. How to mitigate the risk during inspection ?
BRUNO MENDEZ
VP Global Quality Head Pharmacovigilance, Sanofi
RISK MANAGEMENT & PLANNING
14:20 – Panel Discussion - From RMPs to REMS: Implementing Effective Next-Generation Risk Management Strategies. Practical Approaches for Modern PV Systems
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
NINA TEO
Senior Manager, Global Patient Safety & Risk Management Alnylam Pharmaceuticals
15:10 – Chairperson closing remarks / Afternoon
Networking Tea/Coffee & End of conference
Our Partners
“We extend our sincere gratitude to the following organizations for their vital role in advancing the future of global drug safety. Their generous support, technical expertise, and dedication are the driving force behind the success of the 41st Pharmacovigilance USA 2026 summit. Together, we are fostering the innovation and collaboration needed to safeguard patients worldwide.”
Title Partner
Key Partners
Associate Partners
Thought Leader
Lanyard Partner
Event Venue
Wyndham Boston Beacon Hill
Boston
USA
+1 617-742-7630
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Innovation Insights – from global industry leaders
Digital Resource Hub – Included
Professional Certificate – 3 Certificates
Best For – Corporate Teams & Decision Makers
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We have secured special room rates for our conference participants who wish to stay at the conference venue hotel “Wyndham Boston Beacon Hill Hotel” during the conference dates.
Once you confirm your participation, our operations team will share the room reservation details along with the booking deadline and the special rates we’ve arranged.
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