AGENDA
Boston, 4 - 6 November 2025
Schedule
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Registration & Expo Hall Opens
Registration & Expo Hall Opens
Organizer's Opening Remarks
Chairperson's Opening Remarks
Keynote Sponsored by ArisGlobal
Keynote Presentation: We Simplify Pharmacovigilance
Sponsored by EVERSANA.
Keynote: Adapting in Real Time: Future-Proofing Pharmacovigilance Through Innovation
In an increasingly dynamic global healthcare landscape, the need for agile, forward-thinking pharmacovigilance systems has never been more urgent. This panel will explore how real-time technologies, predictive analytics, AI/ML tools, and collaborative data ecosystems are revolutionizing the way safety signals are detected, assessed, and acted upon.
Networking, Posters, & Expo Hall Break
Networking, Posters, & Expo Hall Break
Track Chairperson's Opening Remarks
Attendees will gain a deep understanding of how AI, machine learning, and automation are revolutionizing pharmacovigilance by streamlining case processing, enhancing signal detection, and driving operational efficiency. They will explore real-world applications, innovative tools, and forward-looking strategies to build trust in AI and future-proof safety operations across the drug development lifecycle.
Track Chairperson's Opening Remarks
Attendees will gain insights into evolving global pharmacovigilance regulations, harmonization efforts, and compliance strategies across diverse markets. Through expert perspectives and case studies, they will explore how to navigate complex regulatory frameworks, align with international guidance, and implement best practices to ensure safety and compliance on a global scale.
Track Chairperson's Opening Remarks
Attendees will gain practical strategies for identifying, assessing, and mitigating safety risks throughout the product lifecycle. They will explore evolving approaches to benefit-risk management, REMS, and post-market surveillance, with insights into regulatory expectations and innovative tools to enhance patient safety and product oversight.
Track Chairperson's Opening Remarks
Attendees will gain a forward-looking view of how emerging technologies and advanced data analytics are shaping the future of pharmacovigilance. They will explore innovations in real-world evidence, signal detection, and data integration to enhance decision-making, optimize safety monitoring, and support more proactive risk management.
Track Chairperson's Opening Remarks
To be announced.
Track Chairperson's Opening Remarks
To be announced.
Track Chairperson's Opening Remarks
To be announced.
Presentation: Enhancing Productivity with AI: Leveraging ChatGPT for EDSR
Presentation: Navigating Complex Regulatory Frameworks Across the Middle East
Presentation: Operations as a Science - Paving the way Forward for the Standardization of PV Tasks
Presentation: Assessment of the NHSE Dataset's Suitability for Contextualizing Safety Risks
Presentation: Challenges of “Thinking Global” and “Acting Local” in a Global Pharmacovigilance Setting
Presentation: To be announced
Presentation: To be announced
To be announced.
Presentation: Automation in Pharmacovigilance – Friend or Fiend
Automation is already reshaping pharmacovigilance — quietly, compliantly, and effectively. This session explores why automation, not AI, is the real innovation in safety-critical workflows. We’ll discuss regulatory expectations, current use cases, and how rule-based systems deliver reliable, auditable results. Whilst AI remains aspirational, automation is operational — and inspection-ready!
Objectives include:
- Understand the key differences between automation and AI in pharmacovigilance.
- Learn where automation is already successfully used in PV processes.
- Explore regulatory expectations around validated systems and inspection readiness.
- Assess risks of unvalidated AI versus the compliance benefits of automation.
- Discover how hybrid models can balance automation with human oversight.
Sponsored by PharSafer.
Presentation: Sponsored by Arriello
To be announced.
Presentation: Sponsored by COD Research
Sponsored by COD Research.
Presentation: To be announced
Sponsored by Veeva.
Presentation: To be announced
Sponsored by IQVIA
Safety Updates for Cellular Therapies
Sponsored by APCER Life Sciences
Panel to be announced
Reserved for sponsor.
Presentation: Smarter Pharmacovigilance: AI Support for PBRER Preparation
This presentation describes a novel AI-driven system designed to support the authoring of Periodic Benefit-Risk Evaluation Reports (PBRERs), a critical component of pharmacovigilance. The system leverages generative AI, natural language processing, and machine learning to analyze safety data, generate draft content, and ensure alignment with regulatory expectations. Early prototypes have shown promising results in reducing manual workload and improving quality, consistency, and traceability in reporting. The presentation will share key technical insights, challenges encountered, and the potential impact on drug safety operations.
Presentation: Affiliate Audits Reimagined: Tactics, Tools and Transformation
This session introduces an efficiency-focused approach to affiliate auditing. We will explore streamlined tactics, enabling tools, and transformation strategies that shift audits from routine assessments to high-impact, risk-based evaluations. The session will involve a discussion on how to enhance audit planning and enable data-driven decision-making - ensuring your audits deliver real value in today’s complex environment.
Presentation: To be announced
To be announced.
Presentation: To be announced
To be announced.
Presentation: Understanding Benefit-Risk Assessment in Oncology
Presentation: Signal Detection in Early Phase Clinical Drug Trials
Sponsored by Soterius.
Presentation: From Clinical to Commercial: Safety Monitoring for Rare Gene Therapies
Presentation: To be announced
Sponsored by Parexel.
Presentation: To be announced
Sponsored by Pinnaxis.
Presentation: To be announced
To be announced.
Presentation: To be announced
Reserved for sponsor.
Panel: Beyond Cost: Reclaiming Quality in Pharmacovigilance Outsourcing
As outsourcing in pharmacovigilance accelerates, how do we ensure patient safety isn’t compromised by cost-driven decisions? This panel explores the role of QA and QMS in the vendor selection process, making the case for pre-qualification audits and robust quality metrics before contracts are signed.
Join our thought leaders to debate how we can embed quality from the outset — and why PV QA voices must be central to outsourcing strategy.
The objectives of this panel discussion will:
- Examine how QMS and KPIs can guide the selection and oversight of outsourced PV vendors.
- Discuss the growing need for robust pre-qualification audits — not just post-selection oversight.
- Debate whether cost is driving outsourcing decisions at the expense of quality.
- Explore how QA teams can influence vendor selection with risk-based, patient safety–focused criteria.
- Share strategies to embed quality metrics early in the decision-making process, not retrospectively.
Sponsored by PharSafer.
Panel: Delivering Transformative Results Not Hype, a Safety IT Perspective
Panel: Patient Safety Considerations in High-Risk Therapeutic Innovation: CV and Rare Disease in Focus
Sponsored by Clinigen.
Panel: To be announced
PR1SM: Patients Really are 1st in Signal Management A Novel Machine Learning Based Safety Alert Detection Application
Presentation: To be announced
Presentation: To be announced
To be announced
Presentation: Operationalizing AI Software - A Business Context
Sponsored by Ultragenic Research & Technologies LLC.
Presentation: The Voice of the Patient in Risk Management
Presentation: To be announced
Sponsored by Oracle Health.
Networking, Poster, & Expo Break
Networking, Poster, & Expo Break
Track Chairperson's Opening Remarks
Attendees will gain a deep understanding of how AI, machine learning, and automation are revolutionizing pharmacovigilance by streamlining case processing, enhancing signal detection, and driving operational efficiency. They will explore real-world applications, innovative tools, and forward-looking strategies to build trust in AI and future-proof safety operations across the drug development lifecycle.
Track Chairperson's Opening Remarks
Attendees will gain insights into evolving global pharmacovigilance regulations, harmonization efforts, and compliance strategies across diverse markets. Through expert perspectives and case studies, they will explore how to navigate complex regulatory frameworks, align with international guidance, and implement best practices to ensure safety and compliance on a global scale.
Track Chairperson's Opening Remarks
Track Chairperson's Opening Remarks
Attendees will gain a forward-looking view of how emerging technologies and advanced data analytics are shaping the future of pharmacovigilance. They will explore innovations in real-world evidence, signal detection, and data integration to enhance decision-making, optimize safety monitoring, and support more proactive risk management.
Track Chairperson's Opening Remarks
To be announced.
Track Chairperson's Opening Remarks
To be announced.
Track Chairperson's Opening Remarks
To be announced.
Panel: Neuropharmacovigilance: Anticipating Cognitive Risk Signals in the Age of Digital Therapeutics and Psychedelic Drug Development
Panel: To be announced
Sponsored by Syneos Health.
Panel: To be announced
Panelists to be announced.
Sponsred by Orbit by Feith Systems.
Presentation: Challenges in Pharmacovigilance Data Migration for Medium and Small Companies
Presentation: inspection/ audit realm or concerning deviations/CAPAs
Presentation: To be announced
Sponsored by ThermoFisher Scientific.
Presentation: The Role of Medical Doctors: Harnessing Medical Expertise in Risk Management
Presentation: To be announced
Reserved for sponsor.
Presentation: To be announced
Reserved for sponsor.
Presentation: TOTALVigilance in Action – A Case Study: Harnessing Agentic AI/ Automation/ Digital for Proactive PV Oversight, Operational Efficiency, and Global Process Harmonization
Sponsored by Techsol Life Sciences.
Fireside Chat: International Collaborations to Support Capacity Strengthening in PV
Presentation: Patient Safety Blueprint: Strategies for Emerging Biotech Companies
As emerging biotech companies bring novel therapies to market at record pace, patient safety must remain a core pillar of success. Yet smaller organizations often face unique challenges, including limited resources, evolving infrastructure, and the need to navigate complex global regulatory landscapes. This session will outline practical, scalable strategies to build a robust patient safety framework from early development through commercialization. Topics will include embedding safety considerations into clinical development, leveraging technology and partnerships for efficient pharmacovigilance, aligning safety strategy with evolving regulations, and fostering a proactive safety culture across small teams. Attendees will gain a blueprint for prioritizing patient protection while maintaining innovation and agility, ensuring safety becomes a catalyst—not a barrier—to growth.
Presentation: AI Based Safety Algorithms in Cell and Gene Therapies
Presentation: Global approaches to benefit-risk management following recent EMA, FDA, and CIOMS guidance
Presentation: Quality Management Maturity: How to Strategically and Operationally Build and Scale a QMS Over Time as a Variable of the Product Development Lifecycle
Presentation: Streamlining ICSR Replication with a new paradigm for accuracy and efficiency
Reserved for Transcelerate.
Panel: Navigating the ACNU Framework: Implications for Global Pharmacovigilance
As the ACNU framework continues to take shape, its implications across the pharmacovigilance (PV) ecosystem are becoming increasingly significant. Takeaways from this panel include:
- Understanding the ACNU Framework
- Benefits of ACNU to patients
- Impact of ACNU on PV process
- Technology and Innovation Requirements
- Global Regulatory Considerations
Panel: Newly Released - Benefit-Risk Balance for Medicinal Products, A CIOMS Working Group XII Report
Panelists to be announced.
Presentation: Building trust in AI for drug safety: Lessons from developing a generative AI intake tool
Sponsored by Syneos Health.
Presentation: To be announced
Reserved for sponsor
Presentation: To be announced
Reserved for sponsor.
Presentation: To be announced
Reserved for sponsor.
Presentation: To be announced
Reserved for sponsor.
Presentation: Country Specific PV: Navigating Legislative, Cultural, and Commercial Strategies in a GVP Environment
When building or supporting country-specific PV, there are legislative, cultural, commercial, as well as strategic variables that need to be considered. Here we discuss the framework and tools we use, as well as the challenges and successes from a collective 2 decades of experience.
Presentation: Long-term Follow-Up and Inspection Readiness for Gene Therapies
Presentation: The Renal Explorer: An Open-Source Interactive Graphical Tool to Detect Acute Renal Injury
The Renal Explorer is the latestopen-source tool from the Interactive Safety Graphics taskforce of the American Statistical Association's Biopharmaceutical Safety Working Group. This session will illustrate how instances of acute renal injury arising in clinical trials can be identified and evaluated by this interactive graphical tool.In addition, the accompanying clinical workflow will be introduced, which guides the safety scientist through a series of evaluations, explains how to interpret the results, all referenced back to the primary medical literature
Presentation: To be announced
To be announced.
Presentation:T o be announced
To be announced.
Panel: Advances in safety signal detection using real-world data
For many years, real-world data — e.g., administrative claims and electronic health records — have played a critical role in medical product safety through traditional Post-Approval Safety Studies. With advances in real-world data availability, methods, and tools, real-world evidence is increasingly being used as part of routine pharmacovigilance activities in the signal management process. While less well established, there is growing interest in using secondary real-world data for signal detection to identify new safety observations. Covering multiple stakeholder perspectives, this panel will discuss the current state and future potential of real-world data in signal detection
Panel: From Overload to Access: Streamlining Global Pharmacovigilance in the Age of Information Surplus
In today’s hyper-connected world, pharmacovigilance professionals are faced with an overwhelming abundance of data—ranging from peer-reviewed literature and clinical reports to social media signals and real-world evidence. While this information explosion holds immense potential for improving drug safety, it also presents significant challenges: fragmentation, duplication, and inequitable access, particularly in low- and middle-income countries (LMICs).
This session will explore how global stakeholders are working to streamline, standardize, and integrate diverse data sources to create more cohesive, actionable pharmacovigilance systems. Speakers will highlight innovative technologies, policy frameworks, and collaborative models that are helping to cut through the noise, prioritize meaningful signals, and democratize access to critical safety information.
Panel: Navigating Patient Safety: A Comparative Look Across Pharma, Devices, Cosmetics, and Combination Products
A panel on"Navigating Patient Safety: A Comparative Look Across Pharma, Devices, Cosmetics, and Combination Products"would explore the unique and overlapping safety challenges within each sector. Experts would discuss regulatory frameworks, risk management strategies, and post-market surveillance practices tailored to the specific nature of each product type. The conversation would highlight how innovation, globalization, and evolving consumer expectations are reshaping safety protocols. Ultimately, the session would aim to foster a more integrated approach to patient safety across the life sciences spectrum.
Panel: Navigating the Future of PV Operations: Key Challenges and Emerging Trends
Presentation: From Automation to Intelligence: The Pharmacovigilance Workforce of the Future
Sponsored by Indegene.
Presentation: To be announced
To be announced.
Fireside chat: To be announced
Presentation: To be announced
To be announced.
Short beak before Keynotes
Please join us in Hall C for our afternoon keynotes.
Keynote Fireside Chat: Navigating the responsible use of AI for Drug Safety
Other speakers to be announced.
Keynote: To be announced
To be announced.
Keynote Panel: Global synergy in pharmacovigilance: Bridging Borders for safer medicines
Other panelists to be announced.
Happy Hour!
Join us on the expo floor in Hall C for happy hour!
Create your personal agenda –check the favourite icon
Registration & Expo Hall Opens
Registration & Expo Hall Opens
Keynote Chair Person's Opening Remarks
To be announced.
Keynote: To be announced
Sponsored by Parexel.
Keynote Panel: Regulatory Agency Innovation and Future PV Roadmaps. Where are we going?
Keynote: To be announced
Sponsored by ArisGlobal.
Networking, Poster, and Expo Hall Break
Networking, Poster, and Expo Hall Break
Track Chairperson's Opening Remarks
Attendees will gain a deep understanding of how AI, machine learning, and automation are revolutionizing pharmacovigilance by streamlining case processing, enhancing signal detection, and driving operational efficiency. They will explore real-world applications, innovative tools, and forward-looking strategies to build trust in AI and future-proof safety operations across the drug development lifecycle.
Track Chairperson's Opening Remarks
To be announced.
Track Chairperson's Opening Remarks
Attendees will gain practical strategies for identifying, assessing, and mitigating safety risks throughout the product lifecycle. They will explore evolving approaches to benefit-risk management, REMS, and post-market surveillance, with insights into regulatory expectations and innovative tools to enhance patient safety and product oversight.
Track Chairperson's Opening Remarks
To be announced.
Track Chairperson's Opening Remarks
To be announced
Track Chairperson's Opening Remarks
To be announced.
Track Chairperson's Opening Remarks
To be announced.
Company Presentations
To be announced.
Presentation: Fit-For-Purpose Real-World Data for Enhanced Patient Safety: Insights from Rapid Signal Assessment to ICH M14 Implementation
Presentation: How to Plan for Early Phase Safety Strategies
Presentation: Incorporating AI generated cases into databases: Supported by Human Quality Control
Presentation: Regulatory & Compliance of EMA PASS Procedures
Presentation: To be announced
Presentation: Updates on SAR, AE intake, and other use cases
Presentation: Challenges and Bias in PV Literature Review
Sponsored by UBC.
Presentation: Future-proofing pharmacovigilance: Augmenting human expertise with advanced AI/ML technology
In this session, you will explore the compelling benefits for pharmaceutical companies in combining human expertise with advanced technology to optimize pharmacovigilance operations. Learn how integrating human insights with cutting-edge tools, including AI and machine learning, pharma companies can achieve greater efficiency, accuracy, and compliance in their safety monitoring processes. Explore real-world examples and industry research to demonstrate the practical applications and benefits of these integrated solutions in enhancing pharmacovigilance operations.
Sponsoredd by IQVIA.
Presentation: Generative to Agentic AI: Multiplying PV Writing Impact
Sponsored by Quartica.
Presentation: To be announced
To be announced.
Presentation: To be announced
Sponsored by BioPoint.
Presentation: To be announced
Sponsored by Alwis Solutions.
Learning group: How can we Ensure Diversity and Inclusion in Clinical Trials?
Presentation: Quality and Content of Clinical Trial Safety Data in Public Information Sources
Presentation: Strategies that Support Risk Minimization Measures from Beginning to End
Presentation: To be announced
To be announced.
Presentation: To be announced
Presentation: To be announced
To be announced.
Presentation: Selecting or Re-evaluating your Drug Safety Service Provider
Sponsored by Soterius.
Presentation: To be announced
Sponsored by ClinChoice.
Presentation: To be announced
Reserved for sponsor.
Presentation: To be announced
Reserved for sponsor.
Presentation: To be announced
Reserved for sponsor.
Panel: Reference Safety Information in Practice: From Global Standards to Local Execution
As the regulatory landscape evolves, the implementation of Reference Safety Information (RSI) has become a cornerstone of effective pharmacovigilance. This panel will explore how companies navigate the complexities of RSI implementation, from aligning with global standards to addressing region-specific regulatory expectations and operational challenges. Experts will discuss strategies for maintaining consistency across regions, integrating updates into safety systems, and ensuring clear communication with investigators and regulators. Attendees will gain practical insights on best practices, common pitfalls, and the future of RSI management in an increasingly connected global environment.
Panel: Smart Safety: The Future of Risk Management Through Technology
Panel: Technology: Unlocking the Better ways in PV for Safer Drugs
Panel: The Outsourcing Partnership Playbook: Bridging Expectations, Boosting Productivity, and Achieving Mutual Success
Outsourcing safety activities offers several strategic and operational benefits to sponsors. It spans from Global footprint to cost efficiency encompassing access to specialized knowledge, and scalability, among others. However, there are several challenges that need to be taken into consideration. For example, oversight, differences in time zones, quality issues and non-compliance, vendor dependency, costs, and others. Recognizing those factors is the recipe for a successful outsourcing partnership which will be explored in this panel discussion.
Sponsored by ThermoFisher Scientific.
Presentation: Enhancing Patient Safety: Integrating Active and Passive Monitoring in Modern Pharmacovigilance
Presentation: To be announced
Reserved for sponsor.
Reserved for Propharma
Sponsored by Propharma.
Presentation: To be announced
Reserved for sponsor.
Presentation: To be announced
Reserved for sponsor.
Fireside chat: How can PV participate in precision medicine?
Networking, Poster, & Expo Break
Networking, Poster, & Expo Break in Expo Hall C
Track Chairperson's Opening Remarks
To be announced.
Track Chairperson's Opening Remarks
Attendees will gain a deep understanding of how AI, machine learning, and automation are revolutionizing pharmacovigilance by streamlining case processing, enhancing signal detection, and driving operational efficiency. They will explore real-world applications, innovative tools, and forward-looking strategies to build trust in AI and future-proof safety operations across the drug development lifecycle.
Track Chairperson's Opening Remarks
To be announced.
Track Chairperson's Opening Remarks
Attendees will gain practical strategies for identifying, assessing, and mitigating safety risks throughout the product lifecycle. They will explore evolving approaches to benefit-risk management, REMS, and post-market surveillance, with insights into regulatory expectations and innovative tools to enhance patient safety and product oversight.
Track Chairperson's Opening Remarks
To be announced.
Track Chairperson's Opening Remarks
To be announced.
Track Chairperson's Opening Remarks
To be announced.
Panel: Next-generation of PV Experts
Panel: Rebuilding Safety Around the Patient: Moving Medical Safety Beyond the Silo and Back to the Bedside
In an era of increasing complexity in drug development and real-world use, patient safety must be re-centered as a multidisciplinary, patient-facing function - not just a regulatory requirement. This panel,Rebuilding Safety Around the Patient: Moving Medical Safety Beyond the Silo and Back to the Bedside, explores how safety science can evolve beyond traditional silos to actively engage with patients, clinicians, and data at the point of care. Panelists will share practical strategies for bridging the gap between pharmacovigilance and patient experience through cross-functional collaboration, patient-reported outcomes, and ethical transparency. Join us for a thought-provoking discussion on reimagining medical safety as a bedside ally rather than a back-office function.
Presentation: DSUR/PSUR from 3 months to 3 seconds AI learnings and deployment
Presentation: Safety of SPIKEVAX in Pregnant Women and Their Offspring
Presentation: To be announced
To be announced.
Presentation: To be announced
Presentation: To be announced
Reserved for sponsor.
Presentation: To be announced
Reserved for sponsor.
Presentation: To be announced
Reserved for sponsor.
Presentation: To be announced
Reserved for sponsor.
Presentation: To be announced
Reserved for sponsor.
Presentation: Nonclinical Assessment of the Target Organ Safety in Drug Discovery and its Translational Value for Human Subjects
Presentation: To be announced
To be announced.
Presentation: To be announced
To be announced.
Presentation: To be announced
To be announced.
Presentation: To be announced
To be announced.
Presentation: To be announced
To be announced.
Presentation: To be announced
To be announced.
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Emily Ngai
emily.ngai@terrapinn.com
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