AGENDA
Boston, 4 - 6 November 2025
Schedule
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Early Registration Opens & Sponsor Set Up
Early Registration Opens & Sponsor Set Up
Beauty and the Beast: The Realities of Cosmetic Safety in a Consumer-Driven World
Cosmetics may be beautiful, but safety can be a beast. This informal session invites industry professionals to explore the tricky balance between product appeal, consumer expectations, and the reality of safety system costs.
From eyebrow-raising ingredients to under-reported events, we’ll open the floor for candid discussion on how the cosmetics industry can build smarter, scalable, and reputation-saving safety systems — even where regulations lag behind. Join PharSafer for an insightful workshop they will:
- Explore the tension between product innovation, consumer appeal, and regulatory obligations.
- Discuss the types of cosmetic products and the nature of adverse events being reported.
- Share challenges around building a cost-effective but compliant safety system in a low but rapidly growing regulatory environment.
- Engage in open dialogue around best practices for safety monitoring, even without formal pharmacovigilance structures.
- Consider what “good enough” looks like when safety isn’t always legally mandated — but reputationally essential.
Sponsored by PharSafer.
REMS 101
The REMS 101 Workshop, developed by the REMS Industry Consortium (RIC), is a remarkable chance to delve into the world of Risk Evaluation and Mitigation Strategy (REMS). This course offers a comprehensive overview, covering essential topics like policy milestones, REMS requirements, and Elements to Assure Safe Use, Implementation Systems, Assessment Reports, Industry Participants and REMS Program Models. But that's not all! Our workshop will also highlight the significant achievements of the RIC and the practical benefits of being a member.
Attending this workshop will not only expand your knowledge but also provide invaluable insights that can be directly applied to your organization's risk management discipline. You will have the opportunity to learn from industry experts, engage in meaningful discussions, and take away actionable strategies to enhance your REMS programs. This is a unique chance to stay ahead of the curve and make a tangible impact on your organization's safety and compliance efforts.
We are excited to present this workshop and look forward to seeing you there. If you have any further suggestions or questions, please feel free to reach out toinfo@remsconrtium.org.
Setting up Safety and Creating Executive Buy-In for Early Stage Development
Break
Brief break before workshops resume.
Safety Doesn’t Build Itself — Leaders Do
Every safety system has to start somewhere, but the blueprint isn’t always clear. Do you hire first or design first? Build policies or build people? This workshop dives into the messy, motivating work of leading safety from the ground up — where today’s decisions shape tomorrow’s resilience.
Together we’ll:
- Tackle the big question of what to build now vs. what can wait.
- Explore how to spot (and keep) the right talent for an early-stage safety team.
- Define goals that inspire today while preparing for tomorrow.
- Share candid lessons on scaling systems without losing your foundation.
- Talk leadership — how to create a safety culture people want to follow.
Because safety frameworks may run on process, but they last on leadership.
To be announced
To be announced.
Inspection Readiness for Evolving PV Expectations: What Regulators Are Looking For Today
Transforming Safety Science: Harnessing AI and Analytics to Enhance Patient Safety
Join us for an interactive workshop exploring the real-world applications of AI, analytics, and technology in safety science. During this session, we can showcase some transformative and fit-for-purpose initiatives and strategies, including AI-driven literature review, case assessments, integrated data analytics and simple automation using AI. Great opportunity to brainstorm, share ideas, and plan future opportunities as a group. We’ll also delve into the power of new data sources, including real-world evidence (RWE), to enhance understanding of drug use in real-life settings and improve safety outcomes. Discover how these advancements are reshaping the future of drug safety - making it smarter, faster, and more impactful.
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Registration & Expo Hall Opens
Registration & Expo Hall Opens
Organizer's Opening Remarks
Chairperson's Opening Remarks
Keynote: Executive perspective: R&D IT Digital Transformation
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.
Keynote: Deep Research and Agentic AI for Safety Evaluation
Artificial intelligence presents a transformative opportunity for the medical evaluation of adverse events and the investigation of safety signals within pharmacovigilance. Emerging technologies—such as deep research AI and agentic AI systems—can securely access proprietary company data alongside diverse external resources, enabling comprehensive and timely adverse event assessment. This keynote will explore how these advanced AI tools enhance the depth and efficiency of medical review, support earlier signal detection and empower pharmacovigilance physicians to drive data-informed safety decisions across the product lifecycle.
Sponsored by Oracle Health and Life Sciences.
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.
Panel: Neuropharmacovigilance: Anticipating Cognitive Risk Signals in the Age of Digital Therapeutics and Psychedelic Drug Development
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: Automation for Signal Detection
Presentation: Challenges of “Thinking Global” and “Acting Local” in a Global Pharmacovigilance Setting
Presentation: 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: Navigating the Complexities of International PV: Building a Scalable PV System During Geographic Expansion
A Complex Global PV Landscape. International PV is a nuanced field, still far from harmonization. Navigating disparate global PV regulations remains a critical challenge for PV teams and pharma generally. These challenges are further compounded by the need to quickly scale for commercial strategy execution or during strategic geographic expansion, such as global licence approvals or M&A. Success hinges on building sustainable outsourcing models that enable seamless geographic expansion while ensuring local compliance. How does a company implement an efficient Local PV network with centralized orchestration to remove inefficiencies and increase productivity whilst safeguarding compliance and patients
Sponsored by Arriello.
Presentation: Risk Management for Combination Products: Unraveling the Balancing Act Between Drugs & Devices
This session will address:
- The challenges in developing risk management strategies for combination products.
- What are the principles and model applies while creating such strategies, and how it operationally perfomed.
- Willalso discuss on certain case studies and solutions with the best practices and future outlooks.
Sponsored by COD Research.
Presentation: To be announced
Sponsored by Veeva.
Safety Updates for Cellular Therapies: Managing Critical Challenges from Development to Clinical Use
This session coverskey safety updatesfor cellular therapies currently under development or approved for use. When cellular therapies are ready for clinical evaluation, there are significant challenges in managing product safety.
Key Topics Covered:
- Safety Management Challenges:The specific challenges that arise when managing safety of cellular therapy products in clinical settings.
- Latest Developments:How these safety challenges are being managed from the early clinical stage, based on current developments in the field.
- Evolving Expectations:How greater understanding and confidence gained from years of experience with cellular therapies is changing expectations and helping manage safety challenges.
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
Sponsored by IQVIA.
Presentation: Understanding Benefit-Risk Assessment in Oncology
Presentation: What Your Statistician Won’t Tell You: 7 Common Stat Traps in Pharmacovigilance (and How to Beat Them)
In pharmacovigilance (drug safety), we rely on data to detect and assess adverse drug reactions. But data can mislead if we’re not careful - even if you have a statistician on your team. There are certain statistical pitfalls (“stat traps”) that drug safety professionals may fall into when interpreting safety data. Often, a busy statistician might not explicitly warn you about these, assuming they’re understood. Below we’ll explore seven of the most common stat traps in pharmacovigilance andhow to avoid them, using clear examples and storytelling to make the statistics more approachable and memorable.No formulas- just clear visuals and practical guardrails.
Presentation: Patient Safety in Gene Therapy: Considerations in Clinical and Commercial Practice
Patient safety remains the foundation of our work as pharmacovigilance professionals. Tailoring safety monitoring strategies to align with the unique characteristics of treatment types, disease areas, and patient populations is paramount. This session delves into key pharmacovigilance practices in gene therapy, highlighting specific considerations for safety monitoring during clinical trials and their role in shaping product labels. We’ll also briefly explore the nuances of pharmacovigilance in the commercial landscape for gene therapies. Join us for this engaging discussion and share your valuable insights and experiences.
Presentation: Medication Errors and Guidance on Adverse Event Coding in Specific Error
Sponsored by Soterius.
Presentation: To be announced
To be announced
Presentation: To be announced
Sponsored by Pinnaxis.
Presentation: To be announced
To be announced.
Presentation: To be announced
Sponsored by WhatFix.
Delivering Transformative Results from Promises in an AI-era
Join experienced Pharmacovigilance Systems Leaders to discuss what it really takes to successfully implement reality vs. hype and what's changed with AI. We'll cover navigating overselling during the sales cycle, expectation setting, culture and commitment to change - with plenty of lessons learnt along the way. Not one to be missed for PV systems or business leaders looking for actionable insight from industry veterans representing a diverseset of organizations.
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: Patient Safety Considerations in High-Risk Therapeutic Innovation: CV and Rare Disease in Focus
Join Dr. David Chonzi, Dr. John Lee, and Dr. Ricardo Velazquez for an in-depth panel discussion on the evolving landscape of safety in the development of high-risk therapies, with particular emphasis on cardiovascular and rare disease indications. This session will delve into key challenges such as early safety signal detection, rigorous benefit-risk assessment, and the intricacies of clinical trial design—especially in the context of cutting-edge modalities like gene and RNA-based therapies.
Drawing on real-world examples and current regulatory frameworks, the panel will highlight how safety strategies are adapting to match the pace of scientific innovation. Attendees will come away with actionable insights into proactive safety planning across complex, high-stakes clinical development programs.
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: Long-Term Follow-Up and Inspection Readiness for Gene Therapies
Presentation: Precision Pharmacovigilance and its Pragmatic Adoption' Work
Presentation: Operationalizing AI Software - A Business Context
Sponsored by Ultragenic Research & Technologies LLC.
Presentation: The role of Agentic AI in PV
Sponsored by Oracle Health.
Presentation: The Voice of the Patient in Risk Management
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: Patient-Centric Approaches to Safety Signal Causality Assessment and Risk Management
Sponsored by Syneos Health.
Panel: To be announced
Panelists to be announced.
Sponsred by Orbit by Feith Systems.
Presentation: : AI-driven Case Intake Benefits and Key Implementation Considerations
- armacovigilance (PV) case intake is critical in adverse event (AE) reporting, ensuring compliance with global regulatory requirements and maintaining patient safety. However, for many years, the increasing complexity and volume of individual case safety reports (ICSRs) have presented challenges for organizations using manual workflows. Traditional case intake methods, which include receiving, transcribing and validating reports, were becoming increasingly unsustainable as regulatory expectations evolved and the volume of cases increased. Despite the optimism shown by some technology vendors that the use of artificial intelligence (AI), there was scant evidence of significant deployment of AI in real functioning pharmacovigilance systems over the years. Barriers to adaptation were attributed to significant costs of the system configuration and datasets needs for both implementation and ongoing maintenance.
- Discuss barriers to adoption of earlier systems and two key factors which have significantly reduced these barriers over the past four years.
- Re-examine the benefits of AI-assisted case intake and processing.
- Share five key implementation considerations.
In this presentation, PPD™ Functional Service Partnership (FSP) Pharmacovigilance solutions experts:
Sponsored by ThermoFisher Scientific.
Presentation: Early Warning Systems in Patient Safety - From Passive to Active Approaches
Presentation: Global Reach, Local Touch: Revolutionizing Global PV System Through Strategic Affiliate Integration
Can global pharmacovigilance be both locally compliant AND globally efficient? Parexel and Opella reveal how we navigated this industry challenge. Hear firsthand how we partnered to build a global PV system that honors local requirements without sacrificing cost efficiency. The future of optimized pharmacovigilance awaits.
Sponsored by Parexel.
Presentation: inspection/ audit realm or concerning deviations/CAPAs
Presentation:Navigating Data Migration in Pharmacovigilance: Practical Approaches for Medium and Small Enterprises
The pharmacovigilance landscape is increasingly regulated, necessitating efficient and compliant data migration strategies for medium and small enterprises. This presentation delves into the core aspects of data migration, focusing on practical methods, ensuring data integrity, and developing robust migration plans.
We begin by exploring various data migration methods, including manual, E2B, and programmatic approaches, assessing their suitability based on dataset complexity and resource availability. Ensuring data integrity is paramount; thus, we outline best practices for validation and quality assurance, emphasizing compliance with regulatory standards.
Developing a comprehensive data migration plan is crucial, and this presentation provides strategic insights into planning, risk management, and resource allocation to optimize migration processes. We address common technical challenges, such as system compatibility and data cleaning, offering solutions to streamline migration efforts.
Cost and resource management are key considerations, particularly for smaller enterprises. We discuss efficient management strategies to minimize expenses while maximizing outcomes. Lastly, we touch on emerging trends, including AI-driven solutions, that promise to enhance migration efficiency and compliance.
This presentation aims to equip medium and small enterprises with the knowledge and tools needed to successfully navigate the complexities of pharmacovigilance data migration, ensuring seamless transitions while maintaining regulatory compliance.
Presentation: The Role of Medical Doctors: Harnessing Medical Expertise in Risk Management
Medical doctors play a critical, yet often underappreciated, role in the risk management lifecycle of medical devices. Their clinical insight is essential for identifying potential hazards, assessing real-world risks, and shaping safer, more effective products. This presentation explores how physicians contribute across key phases of medical device development and post-market surveillance, including clinical risk identification, usability assessment, adverse event analysis, and patient safety advocacy.
Presentation: To be announced
Reserved for sponsor.
Presentation: To be announced
Reserved for sponsor.
Presentation: To be announced
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: Medical Safety Databases and Challenges with Outsourcing
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
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: 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.
Presentation:To 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
Pharmacovigilance operations are evolving fast—driven by new regulations, global data demands, and advanced safety technologies. Hear experts from Jazz Pharmaceuticals, Moderna, Novo Nordisk, Tango Therapeutics, and Kyowa Kirin, Inc.- U.S. share insights on the biggest challenges and trends shaping the future of PV operations, and what it means for patientsafety.
Panel: To be announced
Reserved for sponsor.
Presentation: From Automation to Intelligence: The Pharmacovigilance Workforce of the Future
Sponsored by Indegene.
Presentation: To be announced
To be announced.
Presentation: Innovation in Action: Realizing the Promise of AI in Jazz Pharma’s Safety Science
As technology continues to transform how we ensure patient safety,Jazzis leaning into AI to revolutionize pharmacovigilance. In this session, we will walk through our innovation journey—highlighting how AI is helping us boost efficiency and accuracy.
Presentation: Release of the CAR-T REMS
Kymriah is the first approved chimeric antigen receptor T-cell (CAR-T) therapy. Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient's own T-cells to fight cancer. Kymriah is the first therapy based on gene transfer approved by the FDA. Kymriah was approved with a Risk Evaluation and Mitigation Strategy (REMS) on August 30, 2017. The REMS served to inform and educate healthcare professionals about the risks that may be associated with Kymriah treatment. In order to support safe patient access, Novartis established a network of certified treatment centers throughout the country which were fully trained on the safe use of Kymriah and appropriate patient care. As a part of the REMS, Kymriah was only to be administered in certified healthcare facilities. All healthcare providers had to take a mandatory test showing adequate knowledge of CAR-T related toxicities of cytokine release syndrome (CRS) and neurological toxicities (NT) and how to manage these risks in order to prescribe, dispense, or administer Kymriah. Subsequent to Kymriah’s approval, many other CAR-Ts emerged in the market, each having their own REMS. Hospitals that administered various CAR-Ts had to therefore certify in multiple programs having differing CRS and NT treatment algorithms. Novartis entered into negotiations with the FDA on streamlining and transitioning the REMS mandates into standard medical practice in 2020. On July 26, 2025, the FDA released the entire class of BCMA and CD19 CAR-T REMS. The presentation will cover the steps that lead up to the release of this REMS.
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: To be announced
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
Keynote: Patient-Centric Pharmacovigilance: Elevating the Patient Voice in Pharmacovigilance
Pharmacovigilance is no longer just about monitoring - it’s about meaningful engagement. This keynote explores how amplifying patient voices is reshaping the future of drug safety. Featuring insights from a recent patient advocate survey and a powerful personal story from Parexel’s Chief Patient Officer, this keynote will also look ahead to the future of PV - where personalized medicine, predictive safety, and AI innovation reshaping the landscape.
Sponsored by Parexel.
Keynote Panel: Regulatory Agency Innovation and Future PV Roadmaps. Where are we going?
Keynote: The Road to AI Success: How to Operationalize for Sustainable Value
Sponsored by ArisGlobal.
Keynote Presentation: Innovation in Pharmacovigilance: Strategies for Personalized Safety
Pharmacovigilance (PV) is evolving to optimize therapeutic outcomes through personalized safety strategies.Emerging data sources, such as social media and wearable technologies, offer opportunities to gather real-world, patient-generated data, but challenges like data quality, regulatory compliance, and cost pressures necessitate advanced solutions.Automation, AI, and advanced analytics are transforming PV processes, enabling faster, more accurate data processing, signal detection, and risk management.AI-driven approaches unlock insights from unstructured healthcare data, enhance efficiency, and enable novel capabilities, though risks like bias, explainability, and regulatory compliance must be managed.
Personalized safety focuses on understanding patient-specific factors driving adverse events, such as immune-related toxicities in cancer immunotherapy.Research on genetic markers, organoid models, and patient-derived tissues is advancing predictive tools for adverse events like liver injury, myocarditis, and skin toxicity.
Collaborations with health authorities, industry experts, and global research teams are key to fostering transparency and innovation.Personalized medicine supports informed consent and shared decision-making, empowering patients to understand how their genetic and personal data influence treatment.
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
Pioneering Neuroscience with Nose to Brain Neurocircuitry- Vistagen Therapeutics
To be announced.
Presentation: Fit-For-Purpose Real-World Data for Enhanced Patient Safety: Insights from Rapid Signal Assessment and RWD Access & Availability Survey
Post-marketing safety assessments traditionally rely on limited data sources that may lack contextual longitudinal insights critical to patient safety. There is an opportunity to fill this gap by leveraging RWD while also supporting benefit–risk assessments, helping reduce post-marketing study demands, and better aligning with regulatory expectations without the necessity of conducting additional studies.
This forum will share findings from a recent industry surveyidentifying key challenges in accessing and applying RWD for patient safety, revealing top barriers and opportunities across a variety of use cases. Participants will gain a deeper understanding of what these common barriers are and where there is anopportunity to expand RWD use in patient safety.
Presentation: How to Plan for Early Phase Safety Strategies
Presentation: Incorporating AI generated cases into databases: Supported by Human Quality Control
Discover how a small pharma company is reshaping pharmacovigilance with AI.In a world where 95% of AI pilots fail to deliver ROI, Wörwag Pharma and AAA-Pharma have defied the odds. This session unveils their journey from skepticism to success—leveraging theralyze.ai to automate E2B R3 case generation, reduce manual workload, and maintain regulatory compliance through human quality control. If you're curious about real-world AI implementation in safety databases, this is a story you won’t want to miss.
From proof-of-concept to practical impact—fast.Learn how rapid development, agile feedback loops, and a commitment to quality enabled a responsive AI system to evolve week by week. Reinhold Schilling shares firsthand insights into overcoming validation challenges, managing risks, and transforming case intake processes. Whether you're in pharma, tech, or compliance, this session offers valuable lessons on making AI work in high-stakes environments.
Presentation: Regulatory & Compliance of EMA PASS Procedures
Presentation: To be announced
To be announced.
Presentation: Updates on SAR, AE intake, and other use cases
Fireside Chat: Tailored for Trust: Redefining PV Outsourcing for Agility, Consistency, and Collaboration
Exploring how emerging sponsors are choosing strategic safety partners—focusing on flexibility, expertise, and long-term value over volume.We'll explore how PV outsourcing has evolved and what trends are shaping the future, challenges and opportunities in outsourcing, and how companies can ensure qualityand consistencyacross internal and external teams. Our panelists will also delve into what successful partnerships look like and how both sides can foster this collaborationfor best outcomes.
Sponsored by BioPoint.
Presentation: Adoptive Cell Therapy in Cancer Treatment: Breakthroughs, Safety Challenges, and What’s Next
Join us for an insightful session on the cutting edge of adoptive cell therapy (ACT) — from tumor-infiltrating lymphocytes (TIL) to engineered T-cell receptors (TCR) and chimeric antigen receptors (CAR). We will highlight landmark successes, including FDA-approved CD19-directed CAR T-cell therapy in hematologic cancers, and take a closer look at the safety challenges that come with these powerful treatments. Discover how advances in managing toxicity are shaping the next generation of ACT and its expanding role in oncology.
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
The pharmacovigilance (PV) landscape is evolving rapidly with advancements in artificial intelligence (AI), transitioning from traditional Generative AI (Gen AI) to the more autonomous Agentic AI. This presentation, titled "Gen AI to Agentic AI: Multiplying PV Writing," explores how this paradigm shift enhances the efficiency, accuracy, and scalability of PV documentation, including Periodic Benefit-Risk Evaluation Reports (PBRERs), Risk Management Plans (RMPs), and adverse event narratives. Gen AI has already revolutionized initial draft generation by leveraging natural language processing to produce high-quality content from structured data. However, Agentic AI takes this further by autonomously managing end-to-end workflows—identifying data gaps, cross-referencing regulatory requirements, and iteratively refining outputs—effectively multiplying productivity while minimizing human oversight. Through case studies, we demonstrate a 40% reduction in writing time and a 25% improvement in compliance adherence when transitioning from Gen AI to Agentic AI systems. Attendees will gain insights into implementation strategies, challenges (e.g., data quality, validation), and future potential, equipping PV professionals to harness AI-driven automation for enhanced safety reporting in a regulatory landscape.
Sponsored by Quartica.
Presentation: To be announced
To be announced.
Presentation: To be announced
Sponsored by Alwis Solutions.
Fireside Chat: AI, Trust, and Transformation: Separating Potential from Hype in Pharmacovigilance
This fireside chat will deliver a compelling narrative around the potential of AI based tools, focusing on the real (human) foundations of deployment like cultural change and building trust.
Learning group: How can we Ensure Diversity and Inclusion in Clinical Trials?
Panel: Women in Pharmacovigilance: Stories of Resilience, Strategy, and Support
This dynamic panel will spotlight the personal and professional journeys of women leading in the field of pharmacovigilance. Panelists will share strategies for navigating career advancement, overcoming industry-specific challenges, and identifying new opportunities for growth.Mentorship and networking will be highlighted as powerful tools for empowerment and career development, along with a conversation on how diverse, inclusive teams strengthen safety outcomes and innovation in PV. Join us for an inspiring and candid dialogue on resilience, strategy, and the supportive networks that help women thrive in this vital field.
Presentation: Modernizing ICSR Management through Multi-Stakeholder Collaboration
The current practice of managing and sharing Individual Case Safety Reports (ICSRs) across the PV ecosystem was established in the 1960s.A new conceptual ICSR management model has been proposed to limit the number of replicates and duplicates in the global PV ecosystem and improve the speed of access to qualitydata for signal detection1While there are many challenges with progressing such a vision, the potential opportunities warrant further exploration.
We seek to use this forum to catalyze action - to start the discussion about how a multi-stakeholder group might partner in international collaboration to design, build, and conduct a pilot to modernize ICSR management and scale ownership to a new way of working. We invite stakeholders to consider joining this effort as collaboration is essential to realizing a more efficient and responsive PV ecosystem.
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: 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: Opportunities and Challenges for AI in Drug Safety: From Automation to Generating Scientific Insights
Artificial intelligence (AI) holds significant promise for strengthening proactive drug safety measures throughout the product lifecycle, spanning pre-clinical research, clinical trials, and post-market surveillance. Regulatory bodies worldwide recognize AI as a powerful tool capable of identifying, monitoring, and mitigating safety risks, such as FDA’s Emerging Drug Safety Technology Program (EDSTP). Drug developers are also poised to harness the power of AI to achieve the best safety profiles for products and reduce development costs.In pre-clinical research, AI-powered quantitative structure-activity relationship (QSAR) models can predict toxicity, helping prevent unsafe compounds from entering clinical trials. In clinical development, AI can help further identify drug characteristics leading to potential adverse events, predict possible drug–drug interactions, and identify high-risk populations. In post-market phases, AI can be applied in adverse drug event detection and automated processing of safety reports. Context-aware machine learning solutions can support pharmacovigilance (PV) departments by automating repetitive tasks, analyzing vast volumes of real-world data, and providing decision support for benefit-risk discussions and causality assessment of safety events. However, several challenges must be addressed. Limitations in data quality and consistency impedes robust development of AI technology. AI technology still needs to mature in areas such as transparency, interpretation, and validation. As a result, uncertainties remain for integrating AI-driven outputs into official safety assessments.Moving forward, collaboration among industry, academia, and regulatory agencies is vital to fully realize AI’s potential in strengthening drug safety. With effective governance, robust datasets, and ongoing methodological innovation, AI can help usher in a new era of efficient, data-driven pharmacovigilance and safer therapeutic developments worldwide.
Presentation: Safety in Gene Therapies
Presentation: Mastering the PSMF: The Pillar of Inspection Readiness
Abstract: First impressions are everything, especially during a Pharmacovigilance Inspection. As the Inspector’s entry point into an organisation’s PV system, the Pharmacovigilance System Master File (PSMF) can be leveraged to showcase continuous improvement in key areas and demonstrate a commitment to patient safety through regulatory compliance.
With real-world examples and practical tips, attendees will learn the role the PSMF plays during Pharmacovigilance Inspections, current best practices and how to anticipate inspector queries.
By adopting a proactive approach to PSMF management, organisations can transform this standard regulatory requirement into a strategic asset that drives transparency, efficiency, and compliance to give the perfect first impression.
Sponsored by ProPharma.
Presentation: Signal Detection in Pharmacovigilance Using Machine Learning: A 10-Year FAERS Data Analysis
Pharmacovigilance is entering a new era. Traditional methods can no longer keep pace with the volume and complexity of safety data. By applying machine learning to a decade of FAERS reports, this study demonstrates how advanced algorithms can reveal safety signals that might otherwise remain hidden. The future of drug safety is all about using clever new tools to predict risks before they happen.
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
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: To be announced
To be announced.
Presentation: To be announced
Presentation: Safety of SPIKEVAX in Pregnant Women and Their Offspring
Presentation: To be announced
Reserved for sponsor.
Presentation: To be announced
Reserved for sponsor.
Presentation: To be announced
Reserved for sponsor.
Presentation: Benefit Risk Assessment in Reverse Vaccinology
The presentation explores the integration of machine learning (ML), artificial intelligence (AI), and automation into vaccine development with a singular emphasis on patient safety. Using the case example of an mRNA vaccine against H5N2 avian influenza, it illustrates how reverse vaccinology, in-silico antigen optimization, and safety-centric design principles can accelerate timelines while ensuring robust safeguards. The cross-functional AI assistant concept is highlighted as a means to streamline collaboration across clinical, regulatory, CMC, and safety domains, while automation reinforced data accuracy and efficiency.
Key innovations include the application of reverse vaccinology with AI for antigen selection and structural modeling, integration of wearable digital health tools for remote safety monitoring, and automation of safety data management to reduce errors. Importantly, the program addressed the limitations of AI by adopting human-led governance, manual validation of outputs, and immutable data storage to mitigate risks of AI hallucinations. Within seven months, sufficient safety and immunogenicity data enabled dose expansion and planning for Phase II trials.
The presentation emphasizes that safety must be embedded from discovery through post-marketing surveillance, supported by structured benefit–risk assessments and regulatory-aligned frameworks such as CDER’s Emerging Drug Safety Technology Program. By combining computational power with human oversight, vaccine development can be both accelerated and made safer, offering a model for future innovation in patient protection.
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.
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