Agenda
October 13-15, 2026
Thomas M.Menino Convention & Exhibition Center, Boston, MA
Boston, 13 - 15 October 2026
Schedule
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Title TBC
Workshop - Inspection Readiness in Action: A Hands-On Workshop for Industry Teams
13.00 - 13.30 Module 1: Inspection Readiness Reality Check
Interactive Poll + Discussion
- What inspectors actually look for vs. what teams over-prepare
- Recent inspection trends and recurring findings
- Readiness myths that hurt inspection outcomes
13.30 - 14.00 Module 2: Building an Inspection-Ready Organization
- Hands-On Framework Walkthrough
- People: roles, training, behaviour under inspection
- Process: SOPs, deviations, CAPAs, vendor oversight
- Data: traceability, documentation, data integrity
14.00 - 15.00 Module 3: Mock Inspection Role-Play
15.30 - 16.00 Module 4: Handling Findings & Difficult Moments
Case-Based Discussion
- 483s, inspection observations, and critical findings
- When to push back vs. when to acknowledge
- Aligning internal teams during inspection stress
Exercise:Draft a real-time response to a mock inspection observation.
16.00 - 16.30 Module 5: Post-Inspection Success & Continuous Readiness
Workshop - Title TBC
Workshop - AI You Can Trust: Hands-on Delivery, Safe by Design and Governance
Workshop - Sponsored by PharSafer
Title & Speaker to be confirmed by PharSafer
Workshop - Transforming Safety Science: Harnessing AI and Analytics to Enhance Patient Safety
Workshop - Signal Detection in Pregnancy using Real World Evidence and Tree Based Scan Statistics
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Panel - From Defence to Offense: Architecting the Future-Ready Vigilance Strategy Across Pharma, Devices, and Cosmetics
Connected Intelligence: How Agentic AI Is Transforming Life Sciences Operations
Agentic AI is no longer a future concept—it is already delivering measurable value across pharmacovigilance and R&D operations. This keynote will explore how leading life sciences organizations are using AI-powered agents to streamline workflows, improve productivity, accelerate decision-making, and reduce operational burden across safety, regulatory, quality, and clinical functions. The guests will also discuss why connected data is essential to maximizing AI's impact, enabling organizations to move beyond siloed processes and create a foundation for more intelligent, efficient, and scalable operations.
From Promise to Proof: How Sanofi Operationalized Governed AI in Pharmacovigilance at Global Scale
In this keynote case study, Sanofi and IQVIA share the real story behind Project ARTEMIS: moving from a heavily customized legacy PV landscape to a production-grade, enterprise-scale operating model that uses governed, human‑in‑the‑loop AI to drive speed and consistency while protecting quality and compliance. We’ll unpack what it took to deliver at Tier‑1 scale, the governance decisions that mattered most, and the implementation lessons others can apply—whether you’re exploring automation in intake or aiming for end-to-end modernization.
Chair
Chair
Representative to be confirmed by Syneos Health
Chair
Evolving Pharmacovigilance – The Future of AI Implementation & Patient Safety
AI-powered Signal and Risk Detection in Pharmacovigilance
Navigating the PV Landscape across Latin America
Systems Thinking Applied to Patient Safety Risk Management
PV data a goldmine and a nervous system
Presentation given by Santosh Srirangam
To be confirmed
Presentation to be given by senior representative from argenx
Automation in Pharmacovigilance: Why It Still Feels Manual – and What Needs to Change
Despite significant investment in automation and AI, pharmacovigilance operations often still feel manual.
Many organisations have introduced tools designed to streamline case processing and improve efficiency. However, in practice, these solutions often shift effort rather than remove it – introducing new layers of oversight, exception handling, and system complexity.
Partial automation, disconnected workflows, and continued reliance on human interpretation mean that the expected gains in efficiency and scalability are not always realised.
As a result, organisations can find themselves managing increasingly complex processes without a corresponding increase in consistency or control.
This session takes a practical look at where current approaches are falling short, and what needs to change to move towards more consistent, reliable, and inspection-ready execution across pharmacovigilance processes.
Mastering Strategies for Risk Management in Medical Device Safety: Integrating Clinical Expertise and Comprehensive Approaches Across the Product Lifecycle
Speaker to be confirmed by PrimeVigilance
Presentation Sponsored by Syneos Health
Title and speaker to be confirmed by Syneos Health
Presentation Sponsored by Indegene
Title & Speaker to be confirmed by Indegene
Presentation Sponsored by Authenticx
Title to be confirmed by Authenticx
Accelerating Pharmacovigilance with AI: from ICSRs identification and aggregate reporting to signal detection and assessment
Promoting Collaboration and Transparency Between Industry and Regulators to Support Meaningful GVP Compliance Oversight
Next-Generation risk management: integrating clinical expertise in mastering strategies for risk management across the product lifecycle
Pharmacogenomics: Driving Personalized Medicine
The Role of Pharmacoepidemiology for Early Versus Late Phase Drug Development
Hype to Impact: A mart-touch approach to operationalizing AI in PV with audit-ready oversight
AI is moving fast in pharmacovigilance, but scaling it safely is where most programs stall. In this session, you will learn how to move from pilot to measurable impact using a smart-touch approach: apply AI to accelerate repeatable, high-volume work while keeping qualified experts accountable for scientific judgment and final decisions. We will share practical patterns PV and safety leaders can use to operationalize AI with audit-ready oversight, including clearly scoped “context of use,” human-in-the-loop checkpoints, risk-based validation, and traceable evidence showing what AI did and what humans approved.
Real-World Evidence in Assessing the Effectiveness of Risk Minimization Measures
Risk Management Tracking
This presentation highlights the evolving need to capture and track regulatory commitments in Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). Drawing on recent experience implementing an RMP/REMS tracking tool, we will discuss the drivers for implementation, tool scope, operational considerations, and key lessons learned from both the sponsor and vendor perspectives.
This session will provide Patient Safety Risk Management experts with practical insights into how a structured tracking tool can improve visibility, strengthen oversight, and support consistent management of global risk management commitments.
Presentation Sponsored by ClinChoice
Title & Speaker to be confirmed by ClinChoice
Taking Control of Safety: The Shift to Sponsor-Owned PV Platforms
Many emerging biopharma and small companies have historically relied on CROs for pharmacovigilance systems, gaining speed and cost efficiency but limiting access to critical data. In today’s environment, lack of timely, comprehensive data and control over the information lifecycle creates clear disadvantages across clinical and post-marketing safety.
As companies grow and complexity increases, these constraints drive higher costs and operational challenges. As a result, more organizations are shifting toward sponsor-owned PV platforms—not just systems to manage processes, but modern platforms that enable AI and provide faster, higher-quality data access.
This session explores when it makes sense to invest in a dedicated safety platform, how requirements evolve as teams scale, and how ownership can enhance transparency, strengthen risk management, and support long-term flexibility. We will also discuss how more standardized, right-sized approaches are lowering barriers, making it practical for lean teams to establish an audit-ready PV foundation earlier.
Lunch
1hour lunch break
Patient Safety Connect
A dedicated power-hour of pre-scheduled, 1:1 meetings designed to solve your specific challenges.
Panel 1 - From Real-World Evidence to Real-World Safety: What’s Working, What’s Not, and What’s Next
Panel 2 - Regulatory Compliance in Focus: Best Practices from Cosmetics, OTCs, Supplements, and Pharma
Panel Sponsored by APCER Life Science
Title & Speakers to be confirmed by APCER Life Science
Panel 4 - Women in PV
Panel Sponsored by COD Research
Title & Speakers to be confirmed by COD Research
Panel 6 – Safety and Risk Management for Inspection Readiness in the AI Era
As artificial intelligence (AI) continues to transform pharmacovigilance, organizations must strike the right balance between innovation, regulatory compliance, transparency, and patient safety.As AI technologies continue to reshape the way organizations operate, a key question emerges: How should inspection and audit readiness evolve in the age of AI? More importantly, How can AI itself become an enabler of continuous inspection readiness, helping organizations remain audit-ready at all times while improving efficiency, compliance, and patient safety?
Join industry leaders at the World Drug Safety Congress Americas to explore the evolving role of AI in drug safety and its impact on inspection readiness, governance, and risk management.
This session will examine critical topics including AI governance frameworks, model explainability, data integrity, and the importance of human oversight in modern pharmacovigilance systems. Discover how organizations can leverage continuous inspection readiness strategies, real-time analytics, and cross-functional collaboration to strengthen compliance and enhance decision-making across safety operations.
Learn practical approaches for integrating AI, real-world evidence, and patient insights into pharmacovigilance processes while meeting evolving global regulatory expectations. Gain valuable perspectives on maintaining transparency, traceability, and accountability in AI-enabled environments.
Join us to explore best practices, emerging regulatory expectations, and actionable strategies that will help your organization prepare for the future of AI-enabled inspections and safeguard patient safety in an increasingly digital world.
Chair
Chair
Chair
Chair
Collaborating with Regulatory Groups for New Drug Applications
Smarter pharmacovigilance: Embedding automated QC to reduce rework, cut costs, and elevate patient safety
- Manual quality control processes are a hidden cost center—catching errors late means rework, delays, and resource drain. This session reveals how embedding automated error detection and completeness validation directly into daily workflows transforms QC from a bottleneck into a competitive advantage.
- Learn how integrated QC solutions achieve higher first-pass quality rates, reduce rework by up to 40%, and free up QC resources for strategic oversight
- We'll present a financial model showing how standardized, automated QC pays for itself through efficiency gains while improving case quality and regulatory readiness
Presentation Sponsored by Pinnaxis
Title & Speaker to be confirmed by Pinnaxis
Beyond FTEs: When Pharmacovigilance Needs Strategy, Not Just Capacity
Beyond FTEs: When Pharmacovigilance Needs Strategy, Not Just Capacity challenges the traditional industry assumption that pharmacovigilance performance issues can be solved primarily through additional headcount or expanded outsourcing. While adequate resourcing remains a fundamental requirement of a compliant PV system, increasing capacity alone rarely addresses the underlying causes of recurring compliance issues, inspection findings, operational inefficiencies, or escalating costs. The concept of this presentation is to explore how governance, oversight, operating model design, vendor management, technology, and leadership accountability often has a greater influence on long-term PV success than resource levels alone. Through a regulatory and business-focused lens, the session will demonstrate why organisations should evaluate the effectiveness of their pharmacovigilance system as a whole rather than focusing solely on staffing metrics.
The presentation also highlights the evolving role of strategic pharmacovigilance advisory services in helping organisations design scalable, inspection-ready, and fit-for-purpose PV systems. Drawing on global regulatory expectations and industry trends, it will explore how sponsors can move beyond reactive resourcing decisions and instead adopt a proactive approach to PV system design, oversight, and continuous improvement. Ultimately, the session positions pharmacovigilance as a strategic business function that requires deliberate leadership and organisational design to support sustainable compliance, operational effectiveness, and future growth.
Presentation Sponsored by Syneos Health
Title & Speaker to be confirmed by Syneos Health
Predictive Safety Platform
To be confirmed
Title TBC
Transforming Safety Signal Detection into End-to-End Decision Intelligence
Beyond the Molecule: Integrating the Exposome, Pharmacogenetics, and Chronic Stress into ADR Assessment and Causality Evaluation
Signal Detection for a Hybrid Workforce - Humans and AI Agents Working Together
Decentralized expertise, centralized efficiency—harmonizing local PV services across global markets through process centralization and automation, derisking inspection readiness
As regulatory requirements grow more complex across jurisdictions, pharmaceutical companies face mounting pressure to maintain local pharmacovigilance expertise whilst controlling costs.
This session explores how organizations can leverage local PV country-specific regulatory experts, while streamlining and automating processes to maximize cost efficiencies and quality compliance.
We'll discuss practical examples and case studies that have shown successful outcome to navigate the local regulatory complexities while supporting quality and fiscal control.
Presentation Sponsored by Clinevo
Title & Speaker to be confirmed by Clinevo
Break
Break of 20 minutes
Patient Safety Connect
A dedicated power-hour of pre-scheduled, 1:1 meetings designed to solve your specific challenges.
Presentation Sponsored by Techsol
Title & Speaker to be confirmed by Techsol
Accelerating Pharmacovigilance Signal Evaluation with AI-Assisted Analytics and Real-World Data
Discover how Oracle Life Sciences Data Intelligence combines AI-assisted workflows with Oracle's Real-World Data (RDW)—a longitudinal dataset of more than 129 million de-identified patients—to support faster, more consistent pharmacovigilance signal evaluation. See how analysts remain in control while AI helps translate clinical questions into transparent analyses, generate real-world evidence, and produce traceable outputs for regulatory review.
Happy Hour
Close of conference & happy hour
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Panel - Shaping the Future of Patient Safety: Regulatory Perspectives and Roadmaps
Presentation - Making Precision Pharmacovigilance Real: The Future Is Already Here
Pharmacovigilance is undergoing a paradigm shift—from retrospective reporting to a proactive, predictive model that can anticipate and prevent adverse drug reactions. This session explores how the integration of real-world data, artificial intelligence, and pharmacogenomics is transforming drug safety into a precision discipline. Through real-world examples and strategic insights, attendees will gain a clear understanding of how to operationalize this evolution. The session concludes with a forward-looking call to action, empowering pharmacovigilance leaders to champion this transformation and drive safer patient outcomes worldwide.
- Explore how precision pharmacovigilance leverages AI, real-world data, and pharmacogenomics to anticipate and prevent adverse drug reactions
- Learn from real-world case studies that demonstrate the tangible impact of predictive safety strategies in global pharmacovigilance
- Leave with a forward-looking call to action and a roadmap to lead the paradigm shift toward safer patient outcomes worldwide.
Panel - From Potential to Trusted Adoption: Scaling Agentic AI in Pharmacovigilance
As AI becomes increasingly embedded across pharmacovigilance, the conversation is shifting from experimentation to trust and operational adoption. In this panel discussion, PV leaders from leading pharmaceutical organizations will share how they are building confidence in AI within regulated environments and what it will take to move beyond 100% manual review of AI-generated outputs.
The discussion will explore governance, validation, performance monitoring, and human oversight, as well as the practical challenges of scaling AI while maintaining compliance, quality, and accountability.
Chair
Chair
Chair
Title to be confirmed
Title to be confirmed
Challenges faced by companies dealing with SFDA audits
Risk Management Inspection Preparedness Best Practices
Risk Management Challenges for Complex and Innovative Therapies
Lessons from Real World Drug Safety
Managing the Complexity of Scale: Why Specialised Safety Providers Outmanoeuvre Large CROs
The clinical development landscape is complex, particularly for rare diseases and specialized therapeutics. Selecting a Pharmacovigilance (PV) partner is a decision that affects not only daily operations but also the ultimate viability of a New Drug Application (NDA) or Biologics License Application (BLA).
Large, integrated CROs hold a healthy position where they excel. This primarily lies with post-marketing, high-volume case-processing transactions and established sponsors with extensive, multi-product portfolios. This is their “sweet spot.” They also have a large pool of professionals to draw from, often siloed within the organization.
This presentation examines the systemic failures often observed when Small, Emerging Biopharma Organizations (SEBOs) partner with a large, integrated CRO for high-stakes clinical trials, particularly in managing their PV system.
Despite SEBOs’ intensive and often frustrating remediation efforts, the rigid, transactional model characteristic of the industry's largest CROs frequently introduces critical risks to study integrity, data quality, and resource management.For specialized clinical programs, transitioning to a nimble, expert-driven PV service provider is not merely a preference, but is quickly becoming aregulatory and financial necessity.
Presentation Sponsored by Shepherd Safety Services at Two Labs
Title & Speaker to be confirmed byShepherd Safety Services at Two Labs
AI-Powered Authoring and Automation for Safety Reporting Across the Product Lifecycle
Title & Speaker to be confirmed by Alpha Life Sciences
From fragmented tracking to intelligence: rethinking regulatory surveillance in pharmacovigilance
Cross functional collaboration in pharmacovigilance
Leveraging Multi-national Observational Studies in Post-marketing Safety Assessment
Estimating the impact of label design on reducing risk of medication errors by applying HEART in drug administration
Lunch
1 hour lunch break
Patient Safety Connect
A dedicated power-hour of pre-scheduled, 1:1 meetings designed to solve your specific challenges.
Panel 1 - AI Start-Ups
Panel 3 - Hot Topics in Hepatic Safety in Drug Development
Panel 4 - Leveraging Technology to Enhance Patient Safety
Panel 5 - Emerging multi-modal real world data sources for medical product safety
Chair
Chair
Chair
Workshop - The Future of Patient Safety: Reimagining ICSR Case Processing Through Automation
Technology and Process Enhancements in Alnylam SRM
Title TBC
Advancing Long-Term Patient Safety Through Human–AI Intelligence and Automation
The presentation will explore how artificial intelligence and automation can strengthen long-term safety surveillance by supporting the identification and prioritization of delayed, cumulative, rare, and emerging safety risks across the product lifecycle. It will also emphasize the importance of a human-in-the-loop approach, in which AI-generated insights are evaluated through clinical judgment, scientific interpretation, and appropriate safety governance. The discussion will include how Human–AI collaboration can support the integration of clinical trial data, spontaneous safety reports, scientific literature, registries, and real-world evidence to improve signal evaluation, aggregate safety assessment, and benefit–risk decision-making.
Fireside Chat
Breaking the Silence: Understanding Patient Barriers to Drug Safety Reporting
Get Involved At patient Safety Congress Americas
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Karolina Bzikot
karolina.bzikot@terrapinn.com
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